SURCICAL

CORRECTION OF
PRESBYOPIA
__I --=- -
Presbyopia
Surgery
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 Edited by
Ming Wang, MD, PhD
CEO, Aier-USA
Clinical Professor, Meharry Medical College
Director, Wang Vision Cataract & LASIK Center—An Aier-USA Eye Clinic
Nashville, Tennessee

Associate Editors
Tracy Schroeder Swartz, OD, MS, FAAO, Dipl ABO
Madison Eye Care Center
Madison, Alabama
Laser Eye Center
Huntsville, Alabama

Nathan Rock, OD, FAAO

Wang Vision Cataract & LASIK Center—An Aier-USA Eye Clinic
Nashville, Tennessee
 Senior Vice President: Stephanie Arasim Portnoy
Vice President, Editorial: Jennifer Kilpatrick
Vice President, Marketing: Michelle Gatt
Acquisitions Editor: Tony Schiavo
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Thorofare, NJ 08086 USA Creative Director: Thomas Cavallaro
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© 2019 by SLACK Incorporated

Cover photo courtesy of Jinfeng Cai, MD.

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Library of Congress Cataloging-in-Publication Data

Names: Wang, Ming X., 1960- editor. | Swartz, Tracy Schroeder, editor. |
Rock, Nathan, editor.
Title: Surgical correction of presbyopia : the fifth wave / edited by Ming
Wang ; associate editors, Tracy Schroeder Swartz, Nathan Rock.
Description: Thorofare, NJ : SLACK Incorporated, [2018] | Includes
bibliographical references and index.
Identifiers: LCCN 2018039613 (print) | LCCN 2018040606 (ebook) | ISBN
9781630914646 (Web) | ISBN 9781630914639 (Epub) | ISBN 9781630914622 (alk.
paper)
Subjects: | MESH: Presbyopia--surgery | Refractive Surgical
Procedures--methods
Classification: LCC RE938.5 (ebook) | LCC RE938.5 (print) | NLM WW 340 | DDC
617.7/55--dc23
LC record available at https://lccn.loc.gov/2018039613

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DEDICATION

To our families.
 CONTENTS
Dedication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .v
Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
About the Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
About the Associate Editors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Contributing Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xv
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii
Foreword by Arthur Cummings, MD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix

Section I History of Refractive and Lens Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

Chapter 1 History of Refractive Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Lisa Martén, MD, MPH; David I. Geffen, OD, FAAO; Tracy Schroeder Swartz, OD, MS, FAAO,
Dipl ABO; Monica Youcefi, OD; Amanda J. Setto, OD; and Paul J. Dougherty, MD
Chapter 2 Overview of Presbyopia and Its Medical Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Atalie C. Thompson, MD, MPH; Samuel Passi, MD; and Terry Kim, MD

Section II Corneal-Based Treatment for Presbyopia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Chapter 3 Excimer and Femtosecond LASER for Treatment of Presbyopia . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Tracy Schroeder Swartz, OD, MS, FAAO, Dipl ABO and Michael Duplessie, MD
Chapter 4 Presbyopia Correction With a Small-Aperture Inlay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Jay S. Pepose, MD, PhD and Mujtaba A. Qazi, MD
Chapter 5 Shape-Changing Inlays: Synthetic Inlays and Allogenic Inlays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Michael Endl, MD; Soosan Jacob, MS, FRCS, DNB; and Amar Agarwal, MS, FRCS, FRCOphth
Chapter 6 Refractive Inlays. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
David I. Geffen, OD, FAAO
Chapter 7 Complex Cases Using Corneal Inlays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Jessica Heckman, OD and Y. Ralph Chu, MD

Section III Lens-Based Treatment for Presbyopia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

Chapter 8 Overview of Refractive Lens Exchange . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Kristin Neatrour, MD; Lisa Sitterson, MD; and George Waring IV, MD, FACS
Chapter 9 Multifocal Intraocular Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Jay Bansal, MD
Chapter 10 Accommodating Intraocular Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
David Varssano, MD
Chapter 11 Extended Depth of Focus Intraocular Lenses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Robert M. Kershner, MD, MS, FACS
Chapter 12 Complex Intraocular Lens Cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .111
Arun C. Gulani, MD, MS and Tracy Schroeder Swartz, OD, MS, FAAO, Dipl ABO

Section IV Sclera-Based Treatment for Presbyopia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123

Chapter 13 Scleral Inserts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Barrie Soloway, MD; Y. Ralph Chu, MD; and Jessica Heckman, OD
Chapter 14 Laser Scleral Microporation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133
AnnMarie Hipsley, PhD, DPT; David H. K. Ma, MD, PhD; Karolinne M. Rocha, MD, PhD;
and Brad Hall, PhD
 viii  Contents

Section V Marketing Issues and Future Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143

Chapter 15 Marketing Surgical Treatment for Presbyopia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .145
Shareef Mahdavi, BA; Li Jiang, MD; and Ming Wang, MD, PhD
Chapter 16 Future of Presbyopia Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .151
Ming Wang, MD, PhD and Nathan Rock, OD, FAAO

Financial Disclosures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159

 ACKNOWLEDGMENTS
I would like to express my sincere appreciation and gratitude toward the associate editors: Dr. Tracy Schroeder
Swartz, for her hard work and dedication, and Dr. Nathan Rock, for his work in assisting Tracy. I would like to
thank the team at SLACK Incorporated, with special thanks to Tony Schiavo.
I would like to also thank all the staff members of Wang Vision Cataract & LASIK Center—an Aier-USA Eye
Clinic: Dr. Sarah Connolly, Dr. Li Jiang, Dr. Nathan Rock, Dr. David Zimmerman, Heather Brown, Jake Cox,
Cameron Daniels, Suzanne Gentry, Alana Grimaud, Scott Haugen, Chloe Jenkins, Anle Ji, Amanda Knight,
Ana Martinez, Shannon McClung, Crystal Micillo, Skyler Nelson, Eric Nesler, Beth Nielson, Ashely Patty, Kayla
Sinyard, Clare Stolberg, Leona Walthorn, Rebekah Whitehead, Haley Wilson, James Wright, and the entire Eye
Surgery Center of Middle Tennessee team.
I have had the good fortune to have the chance to learn from some great teachers over my professional career,
including: my PhD thesis (in laser spectroscopy) advisor, Professor John Weiner; my MD (magna cum laude) the-
sis advisor and Nature paper co-author, Professor George Church at Harvard Medical School and Massachusetts
Institute of Technology; my ophthalmology residency advisors, Professors Larry Donoso and the late William
Tasman at Wills Eye Hospital; my cornea and refractive surgery fellowship mentors, Professors Richard Forster,
Scheffer Tseng, Eduardo Alfonso, Carol Karp, William Culbertson, and Lori Ventura at Bascom Palmer Eye
Institute; my Vanderbilt University colleagues, the late Professors Dennis O’Day, James Elliott, and Donald Gass;
and my colleagues at the University of Tennessee, Professors Barrett Haik, Natalie Kerr, and James Fleming.
I would like thank my national and international colleagues, as well, including: Professors Arun Gulani, Jay
Basal, Ilan Cohen, David Chang, Ron Krueger, Aleksandar Stonjavic, Guiseppe D’lppolito, Francis Muier, Steve
Klyce, Marguerite McDonald, Dan Durrie, Jason Stahl, Steve Slade, George Waring III, George Waring IV, Terry
Kim, Karl Stonecipher, Brian Boxer-Wachler, Terrence O’Brien, Jay Pepose, Guy Kezirian, Noel Alpins, Thomas
Johns, Jack Holladay, Richard Lindstrom, Arlene Howard, Li Li, Bang Chen, Elaine Zhang, Chloe Chen, Nikki
Li, Zhen Long, Lihua Wang, Bao-sung Liu, Michael Zhou, Xiao-bing Wang, Zhi-yu Du, Qin-mei Wang, Li Zhen,
David Liu, Jin-feng Chai, David Dai, Zu-guo Liu, Jun-wen Zen, Zhen Zhou, David Fischer, Heather Ebert, David
Dunham, John Mickner, Tony Ashley, Tony Roberts, Max Li, Dave and Jan Dalton, Jim and July Hiatt, Richard
and Christine Nelson, Mike Fair, Boyang Wang, Charles Grummon, Jerry Moll, Carlos Enrique, Chenhua Yang,
Kenny Markanich, Kip Dotson, Kane Harrison, and John Bransford.
Often one learns as much from fellows that one trains, and I have been fortunate to have a great group of doc-
tors who have been my fellows over the years: Drs. Shin Kang, Ilan Cohen, Uyen Tran, Walid Haddad, Mouhab
Aljaheh, Ke-ming Yu, Yang-zi Jiang, Ray-Ann Lin, Lav Panchal, Lisa Martén, Lance Kugler, Michael George,
Meagan Celmer, Yang Yang, Ruibo Yang, and Li Jiang. I have learned a great deal also from our optometry resi-
dents over the years, Drs. Helen Boerman, David Coward, Shawna Hill, Tracy Winton, Dora Sztipanovits, Kevin
Jackson, Ryan Vida, Bryce Brown, and Sarah Connolly.
Finally, I want to thank my family for their unfailing support and love: my wife Anle Ji, my late father Dr. Zhen-
sheng Wang, my mother Dr. A-lian Xu, my brother Dr. Ming-yu Wang, my son Dennis Wang, my godmother June
Rudolph, and my godfather Misha Bartnovsky.
Ming Wang, MD, PhD
 ABOUT THE EDITOR
Ming Wang, MD, PhD, is the CEO of Aier-USA, Director of Wang Vision Cataract &
LASIK Center—an Aier-USA Eye Clinic in Nashville, and Clinical Professor at Meharry
Medical College.
Growing up in China during the tumultuous Cultural Revolution, Dr. Wang
played the Chinese violin er-hu and learned to dance in order to escape deportation
and a life sentence of hard labor and poverty, a devastating fate that fell upon mil-
lions of youth. He came to America in 1982 with $50, a Chinese-English dictionary,
and a big American dream in his heart. Dr. Wang graduated from Harvard Medical
School and Massachusetts Institute of Technology (MD, magna cum laude) in Boston,
Massachusetts; holds a doctorate degree in laser spectroscopy; and completed his resi-
dency at Wills Eye Hospital in Philadelphia, Pennsylvania, and his corneal and refrac-
tive surgery fellowship at Bascom Palmer Eye Institute in Miami, Florida.
A former panel consultant to the US Food and Drug Administration (FDA) Ophthalmic Device Panel and a
founding director of Vanderbilt Laser Sight Center, Dr. Wang published a paper in the world-renowned journal
Nature. This was followed by his editing of Corneal Dystrophy and Degeneration: A Molecular Genetic Approach
and the following 7 ophthalmic textbooks published by SLACK Incorporated: Corneal Topography in the
Wavefront Era: A Guide for Clinical Application, Irregular Astigmatism: Diagnosis and Treatment, Keratoconus
and Keratoectasia: Prevention, Diagnosis, and Treatment, Corneal Topography: A Guide for Clinical Application
in the Wavefront Era, Second Edition, Atlas and Clinical Reference Guide for Corneal Topography, Refractive
Lens Exchange: A Surgical Treatment for Presbyopia, and Surgical Treatment for Presbyopia: The Fifth Wave.
Additionally, he has published over 120 papers and numerous book chapters.
Dr. Wang holds several US patents for his inventions of new biotechnologies to restore sight, including an
amniotic membrane contact lens, an adaptive infrared retinoscopic device for detecting ocular aberrations, and
a digital eye bank for virtual clinical trials. His invention of amniotic membrane contact lens has been used by
more than 10,000 surgeons in the United States and worldwide in treating ocular surface diseases to restore sight.
Dr. Wang is an investigator in the US FDA clinical trial of a scleral-spacing procedure to treat age-related loss of
near vision (presbyopia) and ultraviolet cross-linking for the treatment of keratoconus. He introduced the fem-
tosecond laser to China and performed China’s first bladeless all-laser LASIK procedure using this laser in 2005.
He also performed the world’s first femtosecond laser–assisted artificial cornea implantation (Alphacor), and the
first Intacs procedure (Addition Technology, Inc) in the United States using a new version of Intacs for advanced
keratoconus.
Dr. Wang was a recipient of the Honor Award from the American Academy of Ophthalmology, the Lifetime
Achievement Award from the Association of Chinese American Physicians, Kiwanis Nashvillian of the Year
Award, and an honorary doctorate degree from Trevecca Nazarene University (Nashville, Tennessee).
Dr. Wang is the CEO of Aier-USA, the US expansion of Aier Eye Hospital, the world’s largest eye group with
more than 300 locations in 3 of the 5 continents providing eye care for more than 2 billion people worldwide; the
founding president of the Tennessee Chinese Chamber of Commerce; and co-founder of Tennessee Immigrant
and Minority Group.
Dr. Wang introduced many state-of-the-art technologies to the state including SMILE, bladeless all-laser
LASIK, KAMRA (CorneaGen), Raindrop (ReVision Optics), laser refractive lens exchange for the treatment of
presbyopia and laser cataract surgery, Intacs and cross-linking for keratoconus, and amniotic membrane contact
lens for ocular surface disease. He performed more than 55,000 procedures (including on more than 4000 doctors)
and runs a busy international referral clinic for post-LASIK and post–cataract surgery complications. He founded
another 501c(3) nonprofit charity, the Wang Foundation for Sight Restoration, which has also helped patients from
more than 40 states in the United States and 55 countries worldwide, with all sight restoration surgeries performed
free of charge.
Dr. Wang is a champion amateur ballroom dancer and a former finalist in the World Ballroom Dance
Championships in the Open Pro-Am International 10 dance. He plays the er-hu and accompanied country music
legend Dolly Parton on her CD Those Were the Days. Dr. Wang organized an annual classical ballroom dance
sight charity event, the EyeBall, and has drawn attendees from all over the United States and around the world.
 ABOUT THE ASSOCIATE EDITORS
Tracy Schroeder Swartz, OD, MS, FAAO, Dipl ABO, currently practices optom-
etry specializing in anterior segment disease in Madison and Huntsville, Alabama.
Originally from Wisconsin, Dr. Swartz attended Indiana University (Bloomington,
Indiana) for her undergraduate education. During optometry school, she served as an
assistant instructor for the biology department and became interested in pediatrics and
strabismus. After completing her doctorate, she pursued a master’s degree in physi-
ological optics, specializing in pediatrics. She served as a faculty member at the Indiana
University School of Optometry for 4 years and earned the Indiana Chapter of the
American Academy of Optometry Gordon Heath Fellowship in 1996.
After completion of her master’s, she relocated to Metro DC, where she specialized
in refractive and corneal surgery and earned her fellowship in the American Academy
of Optometry. She later joined Wang Vision Cataract & LASIK Center in Nashville,
Tennessee. Here, she served as Director of Clinical Operations, Residency Director for the Optometric Residency
Program, and adjunct faculty to the Indiana University School of Optometry. While here, she edited 2 textbooks
with Ming Wang, MD, PhD: Corneal Topography in the Wavefront Era: A Guide for Clinical Application and
Irregular Astigmatism: Diagnosis and Treatment, both published by SLACK Incorporated, as well as authoring
numerous book chapters on refractive surgery, topography, aberrometry, and anterior segment disease. She served
as co-editor for the literature review column for Cataract and Refractive Surgery Today from 2003 to 2008.
She left Nashville for Huntsville, Alabama, in 2008 where she became the Center Director for Vision America.
She edited additional books, Keratoconus and Keratoectasia: Prevention, Diagnosis and Treatment, the Cornea
Handbook, Corneal Topography: A Guide for Clinical Application in the Wavefront Era, Second Edition, and
Refractive Lens Exchange: A Surgical Treatment for Presbyopia, all published by SLACK Incorporated. She joined
Madison Eye Care Center in 2013 and Laser Eye Center in 2015. She is a board member of the Optometric Council
for Cornea, Cataract and Refractive Technology, and served as the Education Chair for the organization prior to
being elected Vice President in 2018. She currently writes blogs for Optometry Times and ODsonFacebook.com.

Nathan Rock, OD, FAAO, currently practices optometry specializing in refractive

and cataract surgery and anterior segment disease in Nashville, Tennessee. Dr. Rock is
originally from Michigan and attended Oakland University (Rochester, Michigan) for
his undergraduate education. In optometry school, Dr. Rock enjoyed opportunities to
participate in humanitarian eye care missions in Nicaragua, Guatemala, and Honduras,
as well as rural Tennessee and Kentucky. He received the Outstanding Clinician
Award and graduated with honors from Southern College of Optometry (Memphis,
Tennessee). Dr. Rock completed a 1-year residency program in primary care with an
emphasis on ocular disease at the Portland Veteran’s Affairs Medical Center, receiving
his certificate through Pacific University (Forest Grove, Oregon). Dr. Rock joined Wang
Vision Cataract & LASIK Center in 2014. He was inducted as a fellow of the American
Academy of Optometry in 2015.
 CONTRIBUTING AUTHORS
Amar Agarwal, MS, FRCS, FRCOphth (Chapter 5) AnnMarie Hipsley, PhD, DPT (Chapter 14)
Chairman Ace Vision Group
Dr. Agarwal ’s Group of Eye Hospitals Silver Lake, Ohio
Chennai, India
Soosan Jacob, MS, FRCS, DNB (Chapter 5)
Jay Bansal, MD (Chapter 9) Director and Chief
Medical Director Dr. Agarwal ’s Refractive and Cornea Foundation
LaserVue Eye Center Senior Consultant
Santa Rosa, California Cataract and Glaucoma Services
Dr. Agarwal ’s Group of Eye Hospitals
Y. Ralph Chu, MD (Chapters 7 and 13) Chennai, India
Founder and Medical Director
Chu Vision Institute Li Jiang, MD (Chapter 15)
Bloomington, Minnesota Assistant to CEO of Aier-USA
Wang Vision Cataract & LASIK Center—An Aier-USA
Paul J. Dougherty, MD (Chapter 1) Eye Clinic
Clinical Instructor of Ophthalmology Nashville, Tennessee
UCLA Stein Eye Institute
Los Angeles, California Robert M. Kershner, MD, MS, FACS (Chapter 11)
Eye Physician and Surgeon
Michael Duplessie, MD (Chapter 3) Refractive and Cataract Surgery
Los Angeles, California President and CEO
Eye Laser Consulting
Michael Endl, MD (Chapter 5) Professor and Chairman
Partner, Fichte Endl & Elmer Eyecare Department of Ophthalmic Medical Technology
Amherst, New York State College
Medical Director Bioscienece Technology Complex
Ambulatory Surgery Center of Niagara Palm Beach Gardens, Florida
Niagara Falls, New York
Terry Kim, MD (Chapter 2)
David I. Geffen, OD, FAAO (Chapters 1 and 6) Professor of Ophthalmology
Gordon Schanzlin New Vision Institute Duke University School of Medicine
La Jolla, California Chief, Cornea and External Disease Division
Director, Refractive Surgery Service
Arun C. Gulani, MD, MS (Chapter 12) Duke University Eye Center
Founding Director and Chief Surgeon Durham, North Carolina
Gulani Vision Institute
Jacksonville, Florida David H. K. Ma, MD, PhD (Chapter 14)
Department of Ophthalmology
Brad Hall, PhD (Chapter 14) Center for Tissue Engineering
Ace Vision Group Chang Gung Memorial Hospital
Silver Lake, Ohio Department of Chinese Medicine
Chang Gung University
Jessica Heckman, OD (Chapters 7 and 13) Taoyuan City, Taiwan
Vice President of Clinical Affairs
Chu Vision Institute Shareef Mahdavi, BA (Chapter 15)
Bloomington, Minnesota President
SM2 Strategic
Pleasanton, California
 xvi  Contributing Authors
Lisa Martén, MD, MPH (Chapter 1)
Medical Director
South Texas Eye Institute
San Antonio, Texas
Kristin Neatrour, MD (Chapter 8)
Medical University of South Carolina
Charleston, South Carolina
Samuel Passi, MD (Chapter 2)
Department of Ophthalmology
Duke University School of Medicine
Durham, North Carolina
Jay S. Pepose, MD, PhD (Chapter 4)
Medical Director
Pepose Vision Institute
Professor of Clinical Ophthalmology
Washington University School of Medicine
St. Louis, Missouri
Mujtaba A. Qazi, MD (Chapter 4)
Director, Clinical Studies
Pepose Vision Institute
Chesterfield, Missouri
Karolinne M. Rocha, MD, PhD (Chapter 14)
Director, Cornea and Refractive Surgery
Storm Eye Institute
Medical University of South Carolina
Charleston, South Carolina
Amanda J. Setto, OD (Chapter 1)
Clinical Research Optometrist
Dougherty Laser Vision
Westlake Village, California
Lisa Sitterson, MD (Chapter 8)
Cornea and Refractive Surgery Fellow
Tufts University/Ophthalmic Consultants of Boston
Boston, Massachusetts
Barrie Soloway, MD (Chapter 13)
New York Eye and Ear Infirmary
New York, New York
Atalie C. Thompson, MD, MPH (Chapter 2)
Department of Ophthalmology
Duke University School of Medicine
Durham, North Carolina
David Varssano, MD (Chapter 10)
Director, Cornea Unit
Director, Anterior Segment
Department of Ophthalmology
Tel Aviv Sourasky Medical Center
The Sackler Faculty of Medicine
Tel Aviv University
Tel Aviv, Israel
George Waring IV, MD, FACS (Chapter 8)
Founder and Medical Director
Waring Vision Institute
Mount Pleasant, South Carolina
Monica Youcefi, OD (Chapter 1)
Los Angeles, California
 PREFACE
Forty percent of the world’s population is presbyopic. The focus of the book Surgical Correction of Presbyopia:
The Fifth Wave is a detailed presentation and discussion of the techniques that have recently become available or are
under active clinical investigation for surgical correction of presbyopia. Presbyopia is the holy grail or the last frontier
of ophthalmology, which we refer to in this book as the fifth wave of refractive and lens surgery.
We have come a long way in our understanding of the mechanism of presbyopia. Through the late 1800s and
1900s, the accepted theory of accommodation was that of Hermann von Helmholtz, a German physiologist. In 1865,
he proposed that accommodation occurred because the lens, pulled on by zonules, became thickened in the center,
producing greater magnification. His friend Franz Cornelius Donders supported his theory in his classic textbook
Accommodation and Refraction of the Eye, published in 1884. Because of this endorsement, no one challenged the
Helmholtz theory for many years.
In 1924, an ophthalmologist, Dr. Lindsay Johnson, of Durban, South Africa, published a challenge to Helmholtz
in the June 1924 issue of Annals of Ophthalmology. Johnson theorized (as others had in the past) that on accommoda-
tion the lens, being pulled on by zonules and pushed by vitreous, moved forward in the eye, producing magnification
and near focus.
In the 1970s and 1980s, brilliant experiments by Dr. Jackson Coleman of New York demonstrated that the vitre-
ous, pulled forward by zonules on accommodation, pushed the lens forward. Many scientific studies have confirmed
the forward movement of the lens with accommodation, and efforts have been aimed at providing the means for this
to occur.
Today, we have a wide variety of treatments available for presbyopia. The surgical treatments for presbyopia discussed
in this book include: corneal solutions, including laser treatments and corneal inlays; lenticular solutions, including
intraocular lenses; and scleral solutions, such as scleral implants and ablation. The indications, benefits, results, and
risks of these procedures are discussed with close attention to clinical applications. Chapters on complex cases will focus
on improving outcomes both with patient and surgical modality selection and postoperative management.
Marketing to presbyopes, particularly plano presbyopes, who rarely present to eye care professionals for treatment,
presents a unique and new challenge. We will discuss some innovative ideas in this area.
This will be the first such comprehensive review of all the state-of-the-art surgical treatments for presbyopia,
including not only those currently available but also those under active clinical investigation. The target audi-
ence of the book is ophthalmology students, practicing ophthalmologists, optometrists, technicians, and opticians.
Presbyopia is the most common refractive condition, and more patients and providers are now actively seeking
surgical solutions.
Ming Wang, MD, PhD
CEO, Aier-USA
Clinical Professor, Meharry Medical College
Director, Wang Vision Cataract & LASIK Center—An Aier-USA Eye Clinic
Nashville, Tennessee

Spencer P. Thornton, MD, FACS

Past President
American Society of Cataract and Refractive Surgery
Clinical Professor
Department of Ophthalmology
University of Tennessee
Nashville, Tennessee
 FOREWORD
Presbyopia (the Greek word meaning aging eyes) is often called the holy grail of ophthalmology. What exactly
is the holy grail? Legends abound about King Arthur and his knights and their search for the Holy Grail. From
Biblical times, the Holy Grail is the cup that Christ drank from at the Last Supper. Today, however, the term holy
grail is typically used to convey the thought that something is very sought after or pursued. Ophthalmology has
benefited enormously from technological advances, and we now have excellent solutions for many conditions,
including myopia, hyperopia, astigmatism, and, to some degree, presbyopia. A universal solution for presbyopia
does still not exist, however, and hence the quest to find the optimal solution has become like the search for the
Holy Grail itself.
The presbyopia problem is huge, mainly because the market is huge. Eventually everyone is going to become
presbyopic, so the market for presbyopic solutions is only going to grow. At any stage, there are close to 2 bil-
lion presbyopes on Planet Earth. And for these presbyopes, visual needs are getting closer in terms of working
distances, with more people using personal computers at work than ever before, then using laptops at home, and
finally having handheld devices with them on an almost-permanent basis. There has never been a bigger need for
near vision than the present time. For those that are presbyopic, this is a frustration. There is further irony that you
need your reading glasses to find your reading glasses. To have functional vision, where you have adequate vision
for distance, intermediate, and near tasks without the use of any visual aids, is a grand prize indeed. Certainly, it
is something that is sought after and pursued, hence the term holy grail.
Besides being an irritating and annoying condition, presbyopia also indicates to the world that you are aging.
With the pursuit of eternal youth, people are more aware than before of trying to appear younger for as long as
possible. Placing on a pair of reading glasses to peruse the menu immediately places the person in an age category
that they may not appreciate. So, besides the crucial functionality issues, there is the cosmetic issue. Additional
reasons why being able to read without glasses has so much value are the recent thoughts that the preservation
of near vision may be one of the most important factors in staving off dementia in older patients. Being able to
see up close without the need for glasses—and thereby remain engaged with the world using newspapers, mobile
devices, Skype, and other personal communication tools—all help to keep the mind active. Not being able to see,
read the expression on people’s faces, delve into the world of books, and stay abreast of the activities important in
your world via your handheld device all contribute to disengagement from the world around you.
The solutions for presbyopia are multiple given that no current solution resolves the problem satisfactorily for
all presbyopia sufferers. Reading glasses and magnifiers are the traditional solutions, but the frustrations related
to their use are well known. Surgical options abound, and many are extremely successful, but their success greatly
depends on very specific patient selection, and there is undoubtedly an element of art in the process of patient
selection and perhaps a lack of science to help with the decision-making process. Multifocal intraocular lenses
(IOLs) including trifocals, extended depth of focus IOLs, small-aperture IOLs, accommodating IOLs, corneal
inlays, corneal presbyopia surgery, scleral approaches using scleral implants or lasers, and even pharmaceutical
approaches with eye drops all form part of the current arsenal in addressing presbyopia without the need for read-
ing glasses. The fact that there are so many possible solutions attests to the truth that there is no universal solution
currently and hence selecting the most appropriate solution for someone is paramount. Finally, we are providing
multiple possible solutions for what is ultimately a dysfunctional lens.
I have known Dr. Wang as a respected colleague for many years but have really gotten to know him more
recently while doing the Physician CEO course at the Kellogg School of Management (Evanston, Illinois). I have
gotten to know him as a deep thinker and someone with a methodical approach. When I look at the Table of
Contents, I can see how well this book has been put together, taking the reader from the beginning, through the
various options, all the way to what the future may look like in this field in years to come. I suspect that the reader
is going to be far better informed after reading or studying this textbook than before and that the material learned
will become part of his or her own thought process, given the structure in which it is presented.
I would not be surprised if this textbook, consisting of contributions from well-respected thought-of leaders
who are super specialists in their fields, under the editorship of Drs. Ming Wang, Tracy Schroeder Swartz, and
Nathan Rock, goes on to become a gold standard for the topic of presbyopia and its surgical management.

Arthur Cummings, MD
Wellington Eye Clinic
Sandyford, Dublin, Ireland
 SECTION ONE
History of Refractive and
Lens Surgery

History of Refractive Surgery
Lisa Martén, MD, MPH; David I. Geffen, OD, FAAO;
Tracy Schroeder Swartz, OD, MS, FAAO, Dipl ABO; Monica Youcefi, OD;
Amanda J. Setto, OD; and Paul J. Dougherty, MD
Refractive surgery is defined as a surgery performed
to reduce dependence on glasses and contact lenses and
improve uncorrected visual acuity. The first eye surgeries
were cataract removals performed in ancient Greece in the
5th century BC.1 The word cataract is derived from a Greek
word meaning fall of water.1 The procedure of couching
was first described in literature by an Indian surgeon in 800
BC using a curved needle to push the lens into the vitreous
cavity.2 This was the only surgery for cataracts performed
for many centuries, until a French surgeon named Jacques
Daviel (1696–1762) performed the first extracapsular cata-
ract extraction in 1747.3 There were no fine sutures at that
time, so patients were not allowed to move after surgery to
avoid expulsive hemorrhages. There was an increased risk
of mortality due to having to remain immobilized with
sandbags for days after surgery. Topical anesthetics such
as cocaine were also used more frequently, which allowed a
more comfortable surgery.2 During the 1850s, lensectomies
started to be performed to reduce myopia, marking the
beginning of refractive surgery.
Before the development of intraocular lenses (IOLs),
the cataract procedure left patients aphakic, severely far-
sighted, and visually impaired. During World War II, it
was noted injured pilots who had glass and plastic in their
eyes had no intraocular inflammatory response. This
inspired Dr. Harold Ridley, an English ophthalmologist,
-3-
1
to use polymethyl methacrylate to develop IOLs in cata-
ract surgery.4 He performed the first IOL implantation in
1949. Over the next few years, other materials were used to
create IOLs and an international symposium on IOLs and
implants was held in 1966. The Intraocular Implant Club
was formed after this meeting, with Dr. Ridley as the first
president.2 Through his innovative work and discoveries,
Ridley single-handedly changed the future of eye surgery.
With the advent of IOLs, cataract surgery became a refrac-
tive procedure.
Cataract surgery continued to evolve with another
advancement developed by Charles D. Kelman, known as
the father of phacoemulsification.5 With extracapsular sur-
gery, patients had a longer healing process, a hospital stay,
a larger incision, sutures, and more risk of complications.
Inspired by his dentist’s ultrasound probe, he developed a
technique using ultrasonic waves to emulsify the nucleus of
the crystalline lens to remove the cataract. The ultrasound
technology was combined into a handpiece with the use
of irrigation and aspiration to fit through a much smaller
incision.2,3
Improvements in A-scan technology to determine
axial length and optical formulas to calculate lens power to
reduce postoperative refraction have improved visual out-
comes. The modern combination of phacoemulsification,
foldable IOLs, biometry, lens formulas, and intraoperative
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 3-8).
© 2019 SLACK Incorporated.
4  Chapter 1
Figure 1-1. RK incisions to reduce myopia.
measurements have evolved cataract surgery into an ideal
refractive procedure. With the ease of an outpatient pro-
cedure, predictable visual outcomes, routine postoperative
care, and minimal restrictions following surgery, cataract
surgery has become the most commonly performed surgi-
cal procedure in any specialty.3
CORNEAL REFRACTIVE SURGERY
As lens surgery was being perfected, corneal surgeries
were also developing. Astigmatism correction with hori-
zontal incisions on the corneal surface was done in the late
1800s.6 Around the same time, L. J. Lans was developing
the beginning theory behind radial keratotomy (RK) in the
Netherlands. He published his theories in a paper in 1898
discussing incisions to reduce irregularity in the cornea.
It was not until the 1930s that the theories were imple-
mented, when a Japanese ophthalmologist, Tsutomo Sato,
started doing surgery on military pilots to correct their
vision using corneal incisions. His incisions were made on
the inner surface of the cornea, causing corneal opacifica-
tion and decompensation, limiting its popularity. In the
1960s, a Russian ophthalmologist, Slava Fyodorov, evolved
the procedure using anterior corneal incisions, leaving a
central clear optical zone. The procedure removed up to
8.0 diopters (D) of myopia with immediate results. The
procedure made its way to the United States in the 1970s by
Leo Bores, increasing the interests of US ophthalmologists
(Figure 1-1).3
The PERK (prospective evaluation of radial keratoto-
my) study was published in 1982. This was the first study
of the safety and efficacy of RK as well as corneal curvature
postoperatively over time. After several peer-reviewed
publications, RK was established as a safe procedure.
There were some side effects, including visual fluctua-
tion, irregular astigmatism, and long-term hyperopic shift
observed in these patients (Figure 1-2). Surgeons were able
to reduce myopia, farsightedness, and astigmatism using
different cuts on the cornea. The surgery gained more and
more popularity in the 1980s and 1990s, due to the appeal
of minimal surgeon training and the potential to help a
multitude of patients. In addition, the procedure was lucra-
tive as a cash procedure in a time of declining insurance
reimbursements.4
RK was followed by automated lamellar keratoplasty
manufactured by Chiron Inc. This procedure used a micro-
keratome to create a deep cut in the cornea to induce a con-
trolled steepening of the central cornea. Vision outcomes
for this procedure noted myopic progression beginning
as early as 3 months postoperatively, long-term refractive
instability, and loss of best-corrected visual acuity.7 Other
serious complications included increased inferior steepen-
ing of the cornea leading to the development of iatrogenic
keratoconus, irregular astigmatism, and ectasia.8 Patients
with enough postoperative ectasia required corneal trans-
plantation. Due to extremely poor outcomes, this procedure
is no longer performed.
The advent of the excimer laser in the 1980s allowed an
opportunity to safely use it on the corneal surface.9 The laser
was originally created and used to make computer chips
with incredible accuracy. This safety and precision allowed
eye surgeons to remove exact amounts of tissue to correct
refractive error better than using RK.3 Photorefractive
keratectomy (PRK) was the first surface ablation refractive
surgery performed. This technique required the corneal
epithelium be debrided, followed by excimer laser ablation
to correct the refractive error. The epithelium was allowed
to grow back. Healing caused a bit of discomfort, and there
is a risk of stromal scarring, but visual acuity results and
advanced nomograms to improve predictability exceeded
expectations. By 1995, 2 excimer lasers were approved by
the Food and Drug Administration for PRK.10
In an effort to perform a less painful procedure and
reduce healing time, microincisional instruments were
developed to precisely cut into the anterior corneal stroma
to create a superficial flap that could be lifted and returned
to its original position. A new surgery was developed called
LASIK that combined corneal flap creation with excimer
treatment of the refractive error on the anterior corneal
stroma (Figures 1-3 and 1-4). This allowed for minimal
postoperative pain and faster healing, as well as a wow
effect for postoperative day 1 patients. While the corneal
flap was created with a microkeratome blade in the begin-
ning and is still used, modern LASIK utilizes femtosecond
laser technology. The femtosecond laser greatly reduces any
complications in the creation of the LASIK flap.11-13
 History of Refractive Surgery   5

Figure 1-2. (A) A central, often decentered area of flattening is typical for corneas status post RK. The
flat keratometry is excessively flat (26.34 D OD) with severe corneal astigmatism (12.1 D). Also note the
difference between the refractive keratometry and simulated keratometry, which will vary in cases of
irregular astigmatism. Note the central irregularity on the local radius of curvature (also called tangential)
map. The elevation map illustrates the variance in corneal shape. (B) The Visual Function Analysis
demonstrates the typical petaloid pattern of 4-incision RK. The simulated letter E illustrates the distortion
resulting in loss of best spectacle correction.

Advances in the type of excimer laser also occurred,
advancing from broad-beam laser to slit-scanning and spot-
scanning, then incorporating wavefront-guided treatments
using a combination of both. Wavefront treatments allowed
the laser to address not only the refractive error, but also
the higher order aberrations that can greatly reduce qual-
ity of vision after surgery. Different customized treatment
technologies including iris registration, autorefractors, eye
trackers, and faster treatment times have refined and revo-
lutionized refractive laser surgery.
Performing excimer treatments also taught surgeons
the limits of these procedures. For those with severe myo-
pia or significant hyperopia, changing the corneal shape to
eliminate the refractive error was problematic. Phakic IOLs
rather than excimer treatment was preferred for those over
-10.0 D of myopia. Refractive lens exchange is preferred for
high hyperopes.
6  Chapter 1

Figure 1-3. Myopic LASIK, by design, flattened the central cornea. The greater the treatment, the greater the
flattening.

Figure 1-4. Hyperopic LASIK, by design, steepened the central corneal to create a hyperopic shift. The total
amount of correction is limited by the reduced best-corrected vision resulting from the central steeping.

Figure 1-5. Hexagonal keratotomy attempts to create central
steepening to induce a myopic shift.
REFRACTIVE SURGERY
FOR PRESBYOPIA
The first refractive surgery to be performed to address
presbyopia was RK. While typically using radial cuts for
myopia, hexagonal cuts for hyperopia were attempted.
Hexagonal keratotomy used 6 linear incisions into the
peripheral cornea in the shape of a hexagon. The incisions
encircle the central cornea in an attempt to correct hypero-
pia by inducing central steepening (Figure 1-5). However,
the results of this procedure were very unpredictable.
Long-term complications included significant amounts of
irregular astigmatism and ectasia that led to vision loss.14
Treatment with rigid gas-permeable lenses or corneal trans-
plantation may be required in some cases. This procedure
has been abandoned because of these complications.
LASIK and PRK were also performed with convention-
al monovision correction. The dominant eye is typically
corrected for emmetropia and the nondominant eye is tar-
geted for myopic to be able to focus objects at near. Studies
have shown that success rates of monovision may range
from 72% to 92.6%.15 However, monovision carries the risk
of inducing anisometropia, reducing binocular visual acu-
ity and stereopsis.16 Patients may not be able to adapt to the
difference between the eyes, which can result in eyestrain
and visual compromise. Laser refractive procedures have
downsides including the potential for inducement of opti-
cal and visual distortions, regression of effect, dry eye, and
complications such as corneal ectasia and haze.
Conductive keratoplasty (Refractec) is a procedure
used for the treatment of hyperopia, hyperopic astigma-
tism, and presbyopia (Figure 1-6). This technique uses
History of Refractive Surgery   7
Figure 1-6. Conductive keratoplasty used radiofrequency waves to
cause contraction in the cornea and induce a myopic shift. The
Dysfunctional Lens Patient Display objectively measures the intraocular
aberrations to determine the Dysfunctional Lens Index value, which is
reduced in the case of a cataract. The opacity map illustrates where
opacification prevents rays from hitting the retina and becomes white
as the opacification progresses.
radiofrequency energy from a fine-tipped needle that cre-
ates a ring-like pattern in the peripheral corneal stroma of
the nondominant eye.17 With this procedure, the collagen
between the spots shrinks and tightens, inducing central
corneal steepening. While this procedure is considered
minimally invasive and can be performed in-office, this
procedure has virtually been abandoned for the treat-
ment of hyperopia and presbyopia due to the universal loss
of effect with time. Side effects include regression after
several years, small refractive correction, and scarring of
the cornea.18 This procedure is still occasionally used in
combination with Intacs (Addition Technology, Inc) for the
treatment of keratoconus.
Another historical treatment similar to conductive
keratoplasty is laser thermokeratoplasty manufactured by
the now-defunct Sunrise Inc (PriaVision Inc). This pro-
cedure was intended for the correction of low hyperopia,
presbyopia, and astigmatism. Using the Hyperion laser
thermokeratoplasty system, a laser beam applied to the cor-
nea reshapes and shrinks the cornea. Corneal tissue is not
removed or cut during this procedure; therefore, the risk
of complications is low and can be performed within sec-
onds. Short-term results are effective, however, the vision
regressed over time. Due to the instability of this procedure,
it is no longer performed.19
As surgeons’ comfort with excimer procedures
increased, the quest for a binocular procedure intensified.
PresbyLASIK/PRK and multifocal treatment patterns were
attempted to allow patients to see at near. Unfortunately,
the multifocality tends to reduce distance vision.
8  Chapter 1
PRESBYOPIA-CORRECTING
LENS IMPLANTS
Cataract surgery or refractive lens exchange was slow to
develop as a treatment for presbyopia, since it is a more inva-
sive procedure. Multifocal IOLs correct presbyopia using
the method of simultaneous vision. The images created by
these lens designs require the patient to perceive the focused
image and ignore blur created by the unfocused image(s).20
The first bifocal lens implants were refractive IOLs,
including the Array and ReZoom (both by Abbott Medical
Optics, now Johnson & Johnson Vision). Refractive lens
design uses concentric zones with different power through-
out the lens. Diffractive implants followed; the ReSTOR
(Alcon Laboratories, Inc) followed by the TECNIS (Johnson
& Johnson Vision). These lenses use the principle of dif-
fraction. When light encounters an obstacle, it slows down
and changes direction. Diffractive zones are located on the
surface of the implant. As light enters each zone, it is directed
to distant and/or intermediate and/or near focal points that
are influenced by the step height as a proportion of wave-
length.20 Furthermore, bifocal diffractive IOLs can be split
into apodized or nonapodized. In the ReSTOR apodized
implant, the diffractive step height decreases when moving
from the center to the periphery of the lens. As the pupil size
increases, more diffractive zones with smaller step heights
are exposed and the light entering is directed largely to dis-
tance focal points. This design theoretically creates better
distance vision in low-light conditions.
Accommodating IOLs attempted to restore accom-
modative ability via ciliary muscle contraction to anteriorly
displace the vitreous, which theoretically results in anterior
movement and changes the shape of the accommodative
lens to increase in power to obtain intermediate and occa-
sionally some near vision. Accommodating IOLs fell into
2 categories: single-optic and dual-optic. The single-optic
design alters the image focal points through anterior move-
ment of the IOL and changes in the lens architecture. The
Crystalens and Trulign toric (Bausch + Lomb) accommo-
dating IOLs are the only Food and Drug Administration–
approved accommodating IOLs with a single-optic design.
Modern treatments for presbyopia include lens
implants, corneal inlays, and excimer procedures, often in
combination. These are discussed in depth in the following
chapters.
REFERENCES
1. Ascaso FJ, Huerva V. The history of cataract surgery. In: Zaidi FH,
ed. Cataract Surgery. London, United Kingdom: IntechOpen; 2013.
2. Cataract surgery across time. Unite for Sight. http://www.unite-
forsight.org/global-health-university/cataract-surgery. Accessed
October 20, 2017.
3. Refractive eye surgery history. Air Force Center of Excellence
for Medical Multimedia. https://www.refractiveeyesurgery.org/
Refractive-Surgery/History. Accessed January 12, 2018.
4. Takhchidi KP, Agafonova VV. The history of radial keritotomy:
a tribute to Svyatoslav Fyodorov. In: Goes FJ, ed. The Eye in
History. New Delhi, India: Jaypee Brothers Medical Publishers;
2013:423-449.
5. Linebarger EJ, Hardten DR, Shah GK, Lindstrom RL.
Phacoemulsification and modern cataract surgery. Surv Ophthalmol.
1999;44(2):123-147.
6. Bellan L. The evolution of cataract surgery: the most common eye
procedure in older adults. Geriatrics and Aging. 2008;11(6):328-332.
7. Automated lamellar keratoplasty. Eur J Implant Refract Surg.
1994;6(4):232-241. doi:10.1016/s0955-3681(13)80285-7.
8. Lyle WA. Hyperopic automated lamellar keratoplasty. Arch
Ophthalmol. 1998;116(4):425. doi:10.1001/archopht.116.4.425.
9. The history of refractive surgery. Improve Your Vision. http://
www.improveyourvision.com/refractive-surgery-center/history_
of_refractive_surgery.html. Accessed January 15, 2018.
10. FDA-approved lasers for PRK and other refractive surgeries. US Food
and Drug Administration. https://www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/
ucm192110.htm. Updated March 12, 2018. Accessed December 12,
2017.
11. Chen S, Feng Y, Stojanovic A, Jankov MR II, Wang Q. IntraLase
femtosecond laser vs mechanical microkeratomes in LASIK for
myopia: a systematic review and meta-analysis. J Refract Surg.
2012;28(1):15-24.
12. Patel SV, Maguire LJ, McLaren JW, Hodge DO, Bourne WM.
Femtosecond laser versus mechanical microkeratome for LASIK: a
randomized controlled study. Ophthalmology. 2007;114(8):1482-1490.
13. Xia LK, Yu J, Chai GR, Wang D, Li Y. Comparison of the femtosec-
ond laser and mechanical microkeratome for flap cutting in LASIK.
Int J Ophthalmol. 2015;8(4):784-790.
14. Murthy S, Rathi V, Mehta P. Deep anterior lamellar kerato-
plasty for the management of iatrogenic keratectasia occurring
after hexagonal keratotomy. Indian J Ophthalmol. 2012;60(2):139.
doi:10.4103/0301-4738.94058.
15. Fawcett SL, Herman WK, Alfieri CD, Castleberry KA, Parks MM,
Birch EE. Stereoacuity and foveal fusion in adults with long-stand-
ing surgical monovision. J AAPOS. 2001;5(6):342-347.
16. Baumeister M, Kohnen T. Accommodation and presbyopia: part 2:
surgical procedures for the correction of presbyopia. Ophthalmologe.
2008;105(11):1059-1073; quiz 1074.
17. Paley GL, Chuck RS, Tsai LM. Corneal-based surgical presby-
opic therapies and their application in pseudophakic patients.
J Ophthalmol. 2016;(2016):1-6. doi:10.1155/2016/5263870.
18. Hersh PS. Optics of conductive keratoplasty: implications for pres-
byopia management. Trans Am Ophthalmol Soc. 2005;103:412-456.
19. Koch DD, Kohnen T, Mcdonnell PJ, Menefee R, Berry M.
Hyperopia correction by noncontact holmium: YAG laser thermal
keratoplasty. Ophthalmology. 1997;104(11):1938-1947. doi:10.1016/
s0161-6420(97)30003-7.
20. The final cut: surgical correction of presbyopia. Review Group:
Vision Care Education. https://www.reviewofoptometry.com/ce/
the-final-cut-surgical-correction-of-presbyopia. Accessed June 26,
2017.

Overview of Presbyopia and
Its Medical Management
Atalie C. Thompson, MD, MPH; Samuel Passi, MD; and Terry Kim, MD
The term presbyopia refers to the gradual loss of
accommodation by the crystalline lens with advancing age.
Patients typically become symptomatic when approaching
middle age. They may report blurry vision when doing near
work, headaches, asthenopia, squinting, and eye strain.1
Identification of presbyopia is important because it is an
easily correctable cause of vision loss in aging individuals,
with many affordable nonsurgical and surgical manage-
ment options. In developing nations, presbyopia remains
widely undertreated due to limits in access to eye care.2
In developed nations, patients have a variety of treatments
available to improve their acuity at near and intermediate
distances. Nonsurgical management options include inex-
pensive over-the-counter plus power reading glasses, pre-
scription spectacles that incorporate a bifocal segment or
progressive lens, multifocal or monovision contact lenses,
and pharmacological drops.1
For previously emmetropic patients, the experience of
developing a new dependency on corrective lenses may be
distressing. Health care providers should reassure patients
that these changes in their vision are a normal part of the
aging process and refer the patient to an eye care specialist
in optometry or ophthalmology for further evaluation and
treatment. Guiding the patient to the best option to cor-
rect his or her evolving refractive error can take some time
and will require patience from the patient and provider as
-9-
2
they move through an iterative process of trial and error.
All decisions should be made in a patient-centered manner
with the goal of improving his or her visual function.
This chapter will review the worldwide epidemiology
of presbyopia, some of the theories behind the physiologic
changes that may contribute to the onset of this condition,
and the nonsurgical management options for presbyopic
patients.
EPIDEMIOLOGY OF PRESBYOPIA
Presbyopia occurs in all adults, with the onset typically
starting around 38 years of age and reaching a peak inci-
dence around 42 to 44 years of age.3 Nearly 100% of patients
will prove symptomatic by the time they are 52 years old.4
Despite the universal development of presbyopia in older
adults, estimating the prevalence and incidence of presby-
opia has proven challenging for a number of reasons. First,
it is difficult to assess the precise onset of such a slowly
developing chronic condition. Second, not all individuals
with presbyopia will present for an examination to an eye
care specialist to confirm their diagnosis. This is particu-
larly true in developing nations, where 94% of the world’s
burden of uncorrected vision impairment due to presbyopia
exists.2 Third, neither the definition of presbyopia nor the
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 9-17).
© 2019 SLACK Incorporated.
10  Chapter 2
methods to measure presbyopia have been standardized.5
Census data frequently rely on subjective self-report of
visual complaints, and few studies have attempted to cor-
relate survey measures with clinical diagnosis.6
Nevertheless, as life expectancy increases, the propor-
tion of aging individuals is growing worldwide and the
prevalence of presbyopia is expected to rise. The United
Nations estimates that in 2015, there were 901 million peo-
ple aged 60 years or older. This constituted a 48% increase
since the year 2000. By 2050, the global population of older
adults is projected to double to nearly 2.1 billion.7
By combining data from multiple surveys, Holden
and colleagues2 have recently attempted to publish global
estimates of presbyopia. They state that there were approxi-
mately 1.04 billion people with presbyopia in 2005. More
than half of these patients either did not have glasses or
had inadequate refractive correction, and 410 million had
functional impairment when trying to perform near tasks.2
Global health researchers should continue to work to
improve access to inexpensive nonsurgical treatments for
presbyopia, especially low plus power reading glasses. Such
interventions stand to make a large impact on the burden of
visual impairment in elderly patients worldwide.
Risk Factors for Presbyopia
In addition to age, several other factors can contribute
to presbyopic symptomatology. Females are more likely to
report presbyopia at an earlier age and may need a higher
plus power corrective lens than males.8 This finding may
stem from shorter arm lengths in women compared to
men, rather than true anatomic differences in the eye.9 At
baseline, hyperopic patients have greater accommodative
demands, and thus they may present sooner with visual
dysfunction from presbyopia. Patients whose vocation or
avocation involves prolonged near work may begin to com-
plain of asthenopia from accommodative fatigue as they
approach middle age. Impaired accommodation is also an
unwanted side effect of a number of major drug classes,
including but not limited to antidepressants, antipsychot-
ics, antispasmodics, antihistamines, anticholinergics, and
anxiolytics. Any trauma to the lens, ciliary muscle, or zon-
ules can also lead to earlier loss of accommodation as well
as earlier development of cataract.1
Physiology of Accommodation
The mechanism of accommodation has been a source
of scientific inquiry for more than half a century. In 1855, a
German physicist by the name of Hermann von Helmholtz
proposed what has become the predominant paradigm used
to explain the relationship between accommodation and the
ciliary muscle.10-12 According to von Helmholtz, whenever
a subject is focused on a distant object, the relaxed ciliary
muscle keeps the zonular fibers at a resting tension because
the internal diameter of the ciliary muscle is maximized.
This places tension on the lens equator, which flattens the
lens and diminishes its dioptric power. During accom-
modation, the ciliary muscle, which is a sphincter muscle,
contracts so that the internal diameter decreases, which
releases tension on the zonules. As the zonules relax, the
lens capsule constricts, leading to a decrease in the equato-
rial lens diameter and an increase in the convexity of the
anterior and posterior lens surfaces. The end result is a
rounder lens that increases the eye’s dioptric power so that
one can focus on near objects (ie, accommodate).10
A rival theory of accommodation was almost immedi-
ately put forth by a Danish ophthalmologist named Marius
Tscherning. In 1895, he published his theory that ciliary
muscle contraction increases the tension in the zonules,
which in turn pushes the cortex around the nucleus to
reshape the lens without modifying its thickness.13 More
recent adaptations of Tscherning’s theory have been pro-
posed by Ronald Schachar. Schachar has postulated that
ciliary muscle contraction during accommodation prefer-
entially increases, rather than decreases, zonular tension at
the equator of the lens. The lens curvature thus increases as
the equatorial lens is pulled toward the sclera.14 Schachar
believes that continued growth of the lens equatorial diam-
eter over time leads to a decrease in the lens-ciliary body
distance, such that the zonules display more slack with
advancing age. This slackening of the zonules contributes
to the loss of accommodation in his model.14-16
Recent work on accommodation in nonhuman pri-
mates and humans, however, has served to challenge
the Tscherning-Schachar theories of accommodation. For
example, using ultrasound biomicroscopy and goniovid-
eography, Glasser and Kaufman17 documented that both
the lens equator and ciliary body moved away from the
sclera during accommodation in monkeys. With the advent
of more modern technology, such as optical coherence
tomography (OCT), Scheimpflug imaging, and magnetic
resonance imaging (MRI), researchers have been able to
document in vivo dynamic changes in the lens and cili-
ary muscle during accommodation. For example, Baikoff
et al18 used OCT to image increasing lens thickness and
decreasing ciliary body diameter during accommodation in
a 19-year-old albino patient. Strenk and colleagues19 have
employed MRI to confirm that the ciliary muscle moves
inward during accommodation. In another study, the lens
diameter and surface area decreased with accommodation
while the lens volume was constant on OCT, indicating that
the lens was incompressible but the capsular bag elastic.20
Such findings seem to support von Helmholtz’s under-
standing that the lens thickens and ciliary body diameter
constricts during accommodation.
Goldberg and colleagues21 recently incorporated
data from biometry, video ultrasound biomicroscopy, and
endoscopy to design a Computer-Animated Model of
Accommodation and Presbyopia (CAMA 2.0) that illus-
trates how the lens, ciliary muscle, and zonules interact
during accommodation and disaccommodation. In this

model, the anterior zonules and posterior zonules have
reciprocal actions on the lens capsule. During ciliary
muscle contraction, for example, the anterior zonules relax
and lose tension, causing the lens to become rounder as they
release tension on the anterior capsule. At the same time,
the posterior zonules stretch and store energy for disac-
commodation. Because the posterior zonules are attached
to the elastic foundation in the Bruch’s membrane and
choroid, they rebound back during ciliary muscle relax-
ation. The anterior zonules simultaneously increase their
tension and pull on the lens in a reciprocal action during
disaccommodation.21
Accommodation and Aging
Although presbyopia is due to a loss of accommoda-
tion in middle age, it is the result of a gradual process that
begins in early childhood. On average, the accommodative
amplitude declines -1.0 diopter (D) for every 4 years, falling
to 6.0 D ± 2.0 D around the age of 40 years. Loss occurs at
a faster rate of -1.5 D for every 4 years between the ages of
40 to 48 years, and then slows down to an average of -0.5 D
decline every 4 years once one reaches 48 years old.22
The reason for this natural decline in the amplitude
of accommodation over time is not fully understood, but
it is likely multifactorial. Histopathologic evidence of
ciliary muscle atrophy and replacement of muscle with
connective tissue over time originally led some to believe
that presbyopia stems from ciliary muscle weakening.23,24
However, such age-related tissue changes may be the result
rather than etiology of presbyopia. Moreover, the decrease
in accommodative amplitude begins in childhood, long
before any atrophic changes occur in the ciliary muscle.25
Well into the seventh decade of life, the ciliary muscle
maintains a fairly constant contractile force as measured by
impedance cyclography.26 Recent MRI studies have failed
to detect any significant relationship between age and the
ability of the ciliary muscle to contract in humans.27 This
long-term constancy in ciliary muscle strength argues
against a strong influence of the ciliary muscle in loss of
accommodation, or presbyopia.
Rather, presbyopia is more commonly attributed to
age-related changes in the lens. Throughout one’s life, the
anterior lens epithelial cells act as progenitors that differ-
entiate into elongated lens fibers layered around the lens
nucleus like concentric rings in a tree. Studies using MRI
and Scheimpflug photography have confirmed that the
lens increases in its anterior-posterior diameter over time,
while the unaccommodated adult diameter of the lens
equator remains fairly constant around 9.0 mm.27,28 The
lens not only becomes thicker, but also stiffens and eventu-
ally opacifies into a cataract as the crystalline lens proteins
undergo posttranslational changes from chronic oxidative
damage.29 Older lenses are markedly stiffer than younger
lenses.30 However, an interesting discovery is that the lens
stiffness is not uniform within the lens itself over time.
Overview of Presbyopia and Its Medical Management   11
In young lenses, the stiffness gradient in the central lens
nucleus appears to be lower than in the cortex. By around
40 years of age, the nucleus and cortex are equally firm, and
after another 10 years, the lens nucleus becomes signifi-
cantly stiffer than the cortex.17,30
While this stiffening of the lens substance is likely
the primary factor contributing to loss of accommodation
over time, changes in the lens capsule may also contribute.
Fincham12 was the first to suggest that the lens capsule
helped to maintain the shape of the lens. He noted that
upon removal of the lens capsule, the lens material seemed
to lose its shape. Von Helmholtz10 later suspected that pres-
byopia was due in part to loss of the elasticity of the lens
capsule with age. Changes in the biomechanical properties
of the lens capsule have been published and seem to cor-
roborate this concept to an extent. For example, Krag and
colleagues31 found that younger lens capsules are not only
thinner but also stronger and more extensible, whereas
older lens capsules are thicker, more brittle, and less
extensible. In their study, changes in lens capsule elasticity
notably started to decline beyond age 35. Thus, lens and
lens capsule properties are likely the primary physiologic
factors driving the loss of accommodation with age, which
contributes to the onset of presbyopia.
Modern Visual Demands
on Presbyopes
Because of the surge in digital and mobile device own-
ership, the average American is connected with a digital
screen throughout the day for over 60 hours per week.32
Eighty-four percent of mobile technology owners use their
devices as second screens while watching television at
the same time.33 Office work spaces are less likely to be
cubicles with a desktop computer and a monitor on a desk.
According to the Citrix Workplace of the Future report, by
2020, the average employee will access the company net-
work from 6 different devices and one-third of employees
will no longer work from a traditional office but rather at
home, field sites, or alternate locations.34 The tablet has
changed the landscape of computing with exceptional
portability. However, the ergonomics of tablets may be
cumbersome. Tablets may be held at any angle for reading,
but for typing, holding a tablet flat is bad for the neck and
spine. Holding a tablet completely perpendicular is bad for
the wrists. A compromise is to hold the tablet at a 30-degree
angle when typing or using the touch screen.35 Ergonomists
suggest accessory keyboards be used for laptops and tablets
to allow for better body positioning. This increases the
working distance from the eye to the laptop screen and may
elevate the height of the screen.
Smartphone ergonomists suggest holding the smart-
phone at eye level, with font size, screen resolution, bright-
ness, and browser setting enlarged for eye comfort held at
arm’s length.36 It has also been suggested that a smartphone
be held while lying down, holding the phone over the face.37
12  Chapter 2
These recommendations may be more beneficial for pos-
ture, but they create significant problems with progressive
spectacle lens wear. Traditional bifocals as well as progres-
sive lenses require the eyes to drop down into the bottom
of the spectacle lens to view the printed reading material.
Computer glasses with blue blocker coatings or “office
lenses” directly address this shortcoming, but patients may
become frustrated with multiple pairs of glasses. These
patients are more likely to pursue surgical correction.
In addition to postural problems, increased smart-
phone usage can lead to increased ocular surface disease. In
the Nielsen Total Audience Report of 2016, they found that
the average American devoted more than 8 hours per day to
screen time.38 Prolonged screen time can lead to a variety of
symptoms including dry eyes, eye strain, headache, blurred
vision, and neck and shoulder pain.39 Reading reduces the
overall blink rate, which is compounded by the eyes being
open in primary rather than downward gaze. In addition
to retinal damage reported with blue LED light exposure,40
LED exposure has been found to increase ocular surface
disease in mice.41 In a recent study by Lee and colleagues,
LEDs of 630-, 525-, and 410-nm wavelengths were used to
irradiate mice. Tear break-up time in the blue wavelength
group was significantly decreased compared with the
control and red wavelength groups. Increased corneal fluo-
rescein staining scores, corneal levels of interleukin-1β and
interleukin-6, reactive oxygen species production in the
DCF-DA (dichlorofluorescin diacetate) assay, and inflam-
matory T cells in the flow cytometry were observed in the
blue group compared with the other groups. The authors
concluded that overexposure to blue light with short wave-
lengths can induce corneal oxidative damage and apoptosis,
which may manifest as increased ocular surface inflamma-
tion and dry eye.41 In another study, increased smartphone
usage and short duration of outdoor activity was strongly
associated with pediatric dry eye disease. Moreover, symp-
toms improved when smartphone usage was reduced.42
Increased ocular surface disease reduces the comfort
of contact lens wear, a common vision correction method
employed by middle-aged and older adults to avoid spec-
tacles. Current presbyopic contact lens options are more
successful than in years past. Modern contact lens materials
often contain hydrogel and siloxane groups, and are termed
SiHi lenses. While these materials allow greater oxygen trans-
mission, are more hydrophobic, and stiffer than conventional
hydrogel lenses, the material encourages lipid deposition,
may suffer from poor wettability, and cause reduced comfort
levels and mechanical complications.43 While more patients
are interested in presbyopic contact lens options, ocular sur-
face disease limits wearing time and often results in contact
lens drop out.44 This also can result in an increased interest
in surgical correction.
NONSURGICAL
TREATMENT OF PRESBYOPIA
The nonsurgical management of presbyopia encom-
passes spectacles, contact lenses, and pharmacological
agents. Selection of the appropriate therapy requires careful
consideration of the patient’s goals for visual performance
and desire for independence from glasses.
Spectacles
There are several options for optical correction of pres-
byopia with glasses. Single-vision spectacles for reading are
a convenient first-line treatment option for patients who
otherwise do not rely on glasses for distance vision. Patients
who are emmetropic at distance can purchase relatively
inexpensive, over-the-counter reading glasses that are a low
plus power. Estimation of the appropriate dioptric power
can be made by measuring the reading distance in meters
and taking the reciprocal (eg, +3.0 D lenses correct for a
33-cm reading distance). Patients with additional refractive
errors, such as hyperopia or astigmatism, can be prescribed
a pair of reading glasses that adds the reading power to the
sphere of their distance manifest refraction. Many myopic
patients, on the other hand, may find it easier to read if they
remove their distance glasses since their natural focal point
is at near.
For patients who want to be able to focus at different
focal lengths while wearing a single pair of glasses, there
are several options (Figure 2-1). Traditional bifocal lenses
preserve the top part of the lens for distance viewing and
incorporate the reading segment into the lower part of the
lens. Single-piece lenses are currently more common than
fused bifocal lenses where the bifocal segment is fused
into the convex part of the lens. Different shapes of read-
ing segments may induce variable amounts of image jump
or image displacement depending on the correction for
distance. Image jump is caused by the prismatic power at
the top of the bifocal segment and is worse if the optical
center of the bifocal is near the bottom of the segment.
Flat-top and executive reading segments minimize image
jump because the optical center is near the top. Image dis-
placement is caused by the combined prismatic effect of the
distance lens and bifocal segment. This tends to be more
problematic for patients than image jump. Round-top read-
ing segments minimize image displacement for hyperopic
patients who wear plus distance lenses but exacerbate image
jump. Flat-top reading segments minimize image displace-
ment and image jump for myopic patients who wear minus
distance lenses.45
Trifocal lenses have similar options for the shape of
the reading segment but are composed of 3 sections: the
large top section corrects for distance vision, a smaller mid-
dle segment corrects for intermediate distances, and the
 Overview of Presbyopia and Its Medical Management   13

bottom segment for near vision (see Figure 2-1C). The trifo-
cal add is usually half the bifocal add and allows a patient
to focus at a distance that is approximately the length of the
patient’s arm.45
The progressive addition lens (PAL) provides clear vision
for a range of distances via a narrow progressive corridor that
smoothly transitions between the distance and near zones in
the lens. One drawback of the PAL is that clear vision at the
intermediate distance is attained within a narrow corridor
(Figure 2-2). Patients may notice distortion in their periph-
eral vision from astigmatism.45 While some patients may
find it difficult to adapt to progressive lenses, many patients
prefer this no-line alternative to the lined bifocal and trifocal
lenses.46 Selecting the appropriate lens style for new presby-
opes may require trialing several different styles before the
patient finds a corrective lens that is both comfortable and
functional for his or her visual demands.
Most lens materials used in single-vision lenses are
also available in bifocal platforms. High-index material is
preferable for the patient whose lens power exceeds 3.0 D in
magnitude. Also, any patient who is monocular or whose
vocation or avocation involves shop-work should be pre-
scribed polycarbonate lenses for eye protection.

Contact Lenses
For presbyopic patients who wish to wear contact lens-
es, several options are available. Presbyopic patients wear-
ing contact lenses to correct for distance vision may wear
single-vision reading glasses when performing near work.
Since many presbyopes prefer to avoid spectacles altogether,
other available options for near vision include monovision,
bifocal, multifocal, and alternating vision contact lenses.
Monovision Contact Lenses
One common approach to increase the range of vision
in patients with presbyopia is to prescribe monovision con-
tact lenses. The nondominant eye is prescribed a contact
lens that corrects for near vision, while the dominant eye
is prescribed a contact lens that corrects for distance vision
but leaves the patient with a small amount of residual myo-
pia.47 Patients can then have vision over a range of distances
as long as adequate suppression of the more blurred image
occurs. Interocular differences up to 1.5 D are usually well
tolerated,48-50 and binocular acuity typically matches that
of the dominant eye. The depth of focus range for each eye
should overlap, and patients may notice improved visual
function during high lighting settings since constricted
pupils will further enhance their depth of focus. If patients
wish to further enhance their depth of focus, binocularity,
and stereoacuity, one or both eyes can be fit with a bifocal
or multifocal contact lens. To achieve extended or enhanced
monovision, one eye is fit with a single-vision contact
Figure 2-1. Spectacle lenses to correct presbyopia may be
lined bifocals or progressive (no line). Lined bifocals include
(A) round-top bifocal, (B) flat-top bifocal, (C) executive
bifocal, and (D) flat-top trifocal. (Diagram created by Atalie C.
Thompson, MD, MPH.)
lens so that visual function is enhanced at the range most
important to the patient, while the other eye is fit with a
multi- or bifocal contact lens. For example, if the patient
wishes to enhance vision at near, then the dominant eye is
corrected for near and the other eye is provided a multi- or
bifocal contact lens. Alternately, if the patient wishes to
enhance vision at distance, the dominant eye is corrected
for distance and the other eye is provided a multi- or bifo-
cal contact lens. Intermediate distance can be improved by
applying partial monovision, in which a weaker near add
is prescribed in one eye. Modified monovision is another
approach in which the dominant eye is center-distance and
the nondominant eye is center-near using bi- or multifocal
lenses. While a variety of monovision combinations exist to
increase a patient’s range of vision, not all patients are able to
adjust to monovision. Disturbance of stereopsis and spatial
disorientation are particularly common for patients requir-
ing adds that exceed +2.5 D.50,51 This may place patients at
a higher risk of tripping and falling.52 Other reported side
effects include difficulty driving53 and diminished contrast
sensitivity.51 The reported success rate for monovision in
presbyopes ranges from 60% to 80%.48,49,55
14  Chapter 2
Figure 2-2. PALs allow full correction from distance to near. The spectacle correction progressively changes
from the full distance to the full near correction as the eyes are lowered in the lens. (Reprinted with permission
from Essilor of America.)
Multi- and bifocal contact lenses come in an array of
designs (Figure 2-3). Bifocal contact lenses may employ
concentric zones, diffraction rings, or alternating vision
designs. Multifocal contact lenses can be diffractive or
refractive, with multiple concentric zones that change
power in a stepwise fashion, or they can be aspheric in
their design.1 A majority of multi- and bifocal contact lens-
es apply the simultaneous-image principle in their design.
Alternating-image contact lenses are the main exception to
this general rule.
Simultaneous Vision Contact Lenses
Simultaneous vision contact lenses place the distance
and near parts of the contact lens over different parts of the
pupil to form 2 superimposed images. The image in focus
will be formed on the retina while another portion of the
lens forms a second out-of-focus image over top. Acuity
should be optimal in high-contrast settings. Concentric
simultaneous vision contact lenses have a central zone that
can be focused at near (center-near) or distance (center-
distance) while it is surrounded by a ring that is focused
at the opposite focal point. For example, in center-near
bifocals, the miotic pupil focuses light at near but when the
pupil dilates, the image at distance moves into focus while
the image at near decreases in contrast and clarity.1
Refractive ring segments can achieve different powers
of focus through an interaction with pupil size and accom-
modation. Pupil constriction helps to focus the light on
the innermost ring, to improve near acuity, while a dilated
pupil shifts the focus to distance. Diffractive contact lenses
have a central diffractive zone, in which the distance focus
is provided by refraction and near focus is provided by dif-
fraction. Simultaneous vision contact lenses may further
extend the depth of focus by apodizing the lens. Aspheric
contact lenses are similar to progressive spectacles, inso-
far that they create an addition power effect by a gradual
change in the contact lens curvature.1
Patients may report a number of side effects while wear-
ing simultaneous vision contact lenses, including spherical
aberration, shadows around the edges of the image, and
reduced contrast sensitivity.56 Concentric multifocal con-
tact lenses will have worse shadowing if they become decen-
tered because of asymmetric point-spread functions.1
 Overview of Presbyopia and Its Medical Management   15

Alternating Vision Bifocal Contact Lenses

Alternating contact lenses are designed to change posi-
tion with respect to the pupil when the patient changes focus
from distance to near. While looking straight ahead, the
pupil looks through the part of the lens that corrects for dis-
tance. When looking down, the lower lid moves the contact
lens upward so that the pupil looks through the lower half
of the lens, which corrects for near. The upward movement
of the contact lens is facilitated by the lower lid pushing on
the prism or truncated part of the lens.47 Unfortunately,
the contact lens may end up being more or less mobile than
desired. If both the distance and near corrections cover the
pupil, then the image quality will be degraded.
Despite the variety of soft and hard contact lens
options for presbyopes, this modality is not particularly
popular in this cohort. An international survey conducted
in 38 nations found that contact lens prescriptions decline
dramatically in older age groups, with the first largest
drop-off around 35 to 44 years of age.57 Reasons for this
are likely multifactorial. Successful contact lens wear may
prove more challenging in older individuals due to sub-
optimal quantity and quality of the tear film, decreased
palpebral fissure, reduced muscular tone in the eyelids,
or comorbid conditions like corneal dystrophies.1 Decline
in manual dexterity, poor sanitation, and limited finances
may further compromise one’s ability to invest in contact
lenses. Whether wearing contact lenses every day or only
in certain circumstances, patients need to be motivated to
maintain appropriate contact lens hygiene. Education on
the potential side effects of contact lens wear is also impor-
tant, to ensure patients understand the potential for dry eye
and limitation in contrast, as well as the high risk of corneal
ulcer if they sleep in their contact lenses.

Pharmacotherapy
Pharmacological agents have the potential to mini-
mize symptoms or dependence on corrective lenses in
patients with early presbyopia by stimulating ciliary body
contraction and pupillary miosis. However, there are only
a handful of peer-reviewed articles assessing whether
patients with presbyopia benefit from treatment with drugs.
Abdelkader58 conducted a randomized placebo-controlled
clinical trial to test the efficacy of carbachol 2.25% and bri-
monidine 0.2% eye drops on middle-aged uncorrected near
visual acuity (UNVA) in presbyopic patients. They hoped
to induce miosis and accommodation with the acetylcho-
line agonist, while prolonging the effect with the alpha-2
agonist. Treated patients stopped using their glasses and
showed an average improvement in UNVA of 4 lines on the
Jaeger scale 1 hour after receiving drops. The effect lasted
approximately 8 to 10 hours.58
A combination drug (pilocarpine 0.247%, phenylephrine
0.78%, polyethylene glycol 0.09%, nepafenac 0.023%, pheni-
ramine 0.034%, and naphazoline 0.003%) has been trialed
in a prospective pilot study of presbyopic patients. In those
Figure 2-3. Contact lenses to correct presbyopia include
(A) alternating bifocal, (B) concentric 2-zone bifocal,
(C) diffractive bifocal, (D) concentric multifocal, and (E)
diffractive-refractive multifocal. (Diagram created by
Atalie C. Thompson, MD, MPH.)
treated, the mean UNVA improved by 2 to 3 lines without
sacrificing distance acuity.59 Pilocarpine was included to
stimulate both miosis and accommodation. Phenylephrine,
pheniramine, and nepafenac help to block ciliary spasm and
reduce the hyperemia from the pilocarpine. Naphazoline
stimulates release of acetylcholine and blocks release of nor-
epinephrine to enhance the effect of pilocarpine.
A newer drug, Presbyeyedrops, combines 2 para-
sympathomimetics and a non-steroidal anti-inflammatory
drug, and has been shown to improve both uncorrected dis-
tance and near acuity in a pilot study.60 A 1-year prospec-
tive study of PresbyPlus, a drug that combines 2 parasym-
pathomimetics and 1 parasympatholytic, demonstrated
16  Chapter 2
3 lines of improvement in Jaeger near acuity in 90% of
subjects.51,61 PresbiDrops is another new drug under inves-
tigation, which incorporates a parasympathomimetic agent
with a non-steroidal anti-inflammatory in an oil-based
formulation. Other groups have combined pilocarpine 1%
and diclofenac 0.1%.62 Liquid Vision contains 2 proprietary
agents that cause pupillary miosis but do not stimulate
ciliary contraction.63 Thus, patients experience improved
depth of focus and acuity through a pinhole effect with-
out having the myopic shift of accommodation that can
compromise distance vision. These drops are designed to
be used in both eyes with a fast onset of action (ie, within
30 minutes), and the duration lasts more than 5 hours.
Preclinical data suggested patient improvement of 3 to 7
lines in near acuity.63
Rather than target the ciliary muscle and iris to treat
presbyopia, drugs can instead be used to pharmacologically
target the natural lens. Dioptin contains EV06, a pro-drug
of lipoic acid that is supposed to soften the lens by decreas-
ing crystalline protein disulfide bond formation.64 The
hope is that accommodative amplitude will improve. The
phase I and II prospective, randomized, double-masked,
multicenter study results were promising, with the treat-
ment group demonstrating improvement in all distance-
corrected near visual acuity efficacy measures when com-
pared to placebo after 3 months of twice daily eyedrops.
Moreover, the drug was well tolerated and no subjects
withdrew due to adverse events or safety concerns.64
Larger, phase III clinical trials are still needed to evaluate
its efficacy in the treatment of presbyopia.
REFERENCES
1. Mancil GL, Bailey IL, Brookman KE, et al. Optometric Clinical
Practice Guideline Care of the Patient with Presbyopia: Reference
Guide for Clinicians. St. Louis, MO: American Optometric
Association Original Consensus Panel on Care of the Patient with
Presbyopia; 2011.
2. Holden BA, Fricke TR, Ho SM, et al. Global vision impairment due to
uncorrected presbyopia. Arch Ophthalmol. 2008;126(12):1731-1739.
3. Kleinstein R. Epidemiology of presbyopia. In: Stark L, Obrecht
G, eds. Presbyopia: Recent Research and Reviews From the Third
International Symposium. New York, NY: Professional Press Books;
1987:12-18.
4. Kleinstein R. Epidemiology of presbyopia. In: Stark L, Obrecht
G, eds. Presbyopia: Recent Research and Reviews From the Third
International Symposium. New York, NY: Professional Press Books;
1987:14-15.
5. Patel D. Community Eye Health MSc dissertations. Community Eye
Health. 2007;20(61):6-7.
6. Walline JJ, Zadnik K, Mutti DO. Validity of surveys reporting myo-
pia, astigmatism, and presbyopia. Optom Vis Sci. 1996;73(6):376-381.
7. World Population Ageing 2015. New York, NY: The United Nations;
2015.
8. Pointer JS. Broken down by age and sex. The optical correction of
presbyopia revisited. Ophthalmic Physiol Opt. 1995;15(5):439-443.
9. Millodot M, Millodot S. Presbyopia correction and the accommoda-
tion in reserve. Ophthalmic Physiol Opt. 1989;9(2):126-132.
10. Von Helmholtz H. Uber die akkommodation des auges. Archiv
Ophthalmol. 1855;1:1-74.
11. Fincham E. The changes in the form of the crystalline lens in
accommodation. Trans Opt Soc. 1925;26(5):239-269.
12. Fincham E. The mechanism of accommodation. Br J Ophthalmol.
1937;8(suppl):1-80.
13. Tscherning M. Recherches sur les changement optiques des
l’oeil pendant l’accommodation. Arch de physiol norm et pathol.
1895;7:158-180.
14. Schachar RA, Tello C, Cudmore DP, Liebmann JM, Black TD, Ritch
R. In vivo increase of the human lens equatorial diameter during
accommodation. Am J Physiol. 1996;271(3):R670-R676.
15. Schachar RA. Cause and treatment of presbyopia with a method
for increasing the amplitude of accommodation. Ann Ophthalmol.
1992;24(12):445-447, 452.
16. Schachar RA. The mechanism of accommodation and presbyopia.
Int Ophthalmol Clin. 2006;46(3):39-61.
17. Glasser A, Kaufman PL. The mechanism of accommodation in pri-
mates. Ophthalmology. 1999;106(5):863-872.
18. Baikoff G, Lutun E, Wei J, Ferraz C. Anterior chamber optical
coherence tomography study of human natural accommodation in
a 19-year-old albino. J Cataract Refract Surg. 2004;30(3):696-701.
19. Strenk SA, Strenk LM, Semmlow JL, DeMarco JK. Magnetic reso-
nance imaging study of the effects of age and accommodation on
the human lens cross-sectional area. Invest Ophthalmol Vis Sci.
2004;45(2):539-545.
20. Martinez-Enriquez E, Perez-Merino P, Velasco-Ocana M, Marcos S.
OCT-based full crystalline lens shape change during accommoda-
tion in vivo. Biomed Opt Express. 2017;8(2):918-933.
21. Goldberg D, Chen J, Waring G. Biomechanics of accommodation
and presbyopia: dysfunctional lens syndrome. In: Wang M, ed.
Refractive Lens Exchange: A Surgical Treatment for Presbyopia.
Thorofare, NJ: SLACK Incorporated; 2016.
22. Azar DT, Azar NF, Brodie SE, et al. Clinical refraction. In: Cantor
LB, Rapuano CJ, Cioffi GA, eds. Clinical Optics. San Francisco, CA:
American Academy of Ophthalmology; 2015:115.
23. Tamm S, Tamm E, Rohen JW. Age-related changes of the human
ciliary muscle. A quantitative morphometric study. Mech Ageing
Dev. 1992;62(2):209-221.
24. Pardue MT, Sivak JG. Age-related changes in human ciliary muscle.
Optom Vis Sci. 2000;77(4):204-210.
25. Borish I. Clinical Refraction. Chicago, IL: The Professional Press
Inc; 1975.
26. Swegmark G. Studies with impedance cyclography on human ocu-
lar accommodation at different ages. Acta Ophthalmol (Copenh).
1969;47(5):1186-1206.
27. Strenk SA, Semmlow JL, Strenk LM, Munoz P, Gronlund-Jacob J,
DeMarco JK. Age-related changes in human ciliary muscle and lens:
a magnetic resonance imaging study. Invest Ophthalmol Vis Sci.
1999;40(6):1162-1169.
28. Cook CA, Koretz JF, Pfahnl A, Hyun J, Kaufman PL. Aging of
the human crystalline lens and anterior segment. Vision Res.
1994;34(22):2945-2954.
29. Michael R, Bron AJ. The ageing lens and cataract: a model of nor-
mal and pathological ageing. Philos Trans R Soc Lond B Biol Sci.
2011;366(1568):1278-1292.
30. Weeber HA, Eckert G, Pechhold W, van der Heijde RG. Stiffness
gradient in the crystalline lens. Graefes Arch Clin Exp Ophthalmol.
2007;245(9):1357-1366.
31. Krag S, Olsen T, Andreassen TT. Biomechanical characteris-
tics of the human anterior lens capsule in relation to age. Invest
Ophthalmol Vis Sci. 1997;38(2):357-363.
32. The Digital Consumer Report 2014 (Rep.). Nielsen. http://www.
n ielsen.com /content /d a m /cor porate/u s/en /repor t s-dow n-
loads/2014%20Reports/the-digital-consumer-report-feb-2014.pdf.
Published February 2014. Accessed May 28, 2018.

33. Problems and conditions. The Vision Council. https://www.thevi-
sioncouncil.org/content/digital-eye-strain. Accessed June 15, 2017.
34. Middlesworth M. Ergonomics, mobile devices and the workplace
of the future. Ergonomics Plus. http://ergo-plus.com/ergonomics-
mobile-devices-workplace/. Accessed May 28, 2018.
35. Gordon W, Dachis A. You’re holding it wrong: here’s how to
hold your touch screen gadgets correctly. Lifehacker. http://life-
hacker.com/5876996/youre-holding-it-wrong-heres-how-to-hold-
your-touch-screen-gadgets-correctly. Published January 17, 2012.
Accessed May 28, 2018.
36. Risk Services. University of California: Office of the President. http://
www.ucop.edu/risk-services/loss-prevention-control/ergonomics/
ergo-mobile.html. Accessed May 28, 2018.
37. Berry M. Cell phone ergonomics: how to avoid the “smart phone
slump.” Breaking Muscle. https://breakingmuscle.com/fitness/
cell-phone-ergonomics-how-to-avoid-the-smart-phone-slump.
Accessed May 28, 2018.
38. The Total Audience Report: Q1 2016. The Nielsen Company. http://
www.nielsen.com/us/en/insights/reports/2016/the-total-audience-
report-q1-2016.html. Published June 27, 2016. Accessed July 25,
2018.
39. Computer Vision Syndrome. American Optometric Association.
https://www.aoa.org/patients-and-public/caring-for-your-vision/
protecting-your-vision/computer-vision-syndrome. Accessed July
25, 2018.
40. Kuse Y, Ogawa K, Tsuruma K, Shimazawa M, Hara H. Damage
of photoreceptor-derived cells in culture induced by light-emit-
ting diode-derived blue light. Sci Rep. 2014;4:5223. doi:10.1038/
srep05223.
41. Lee HS, Cui L, Li Y, et al. Influence of light emitting diode-derived
blue light overexposure on mouse ocular surface. PLoS One.
2016;11(8):e0161041. doi:10.1371/journal.pone.0161041.
42. Moon JH, Kim KW, Moon NJ. Smartphone use is a risk factor for
pediatric dry eye disease according to region and age: a case con-
trol study. Ophthalmology BMC Series. 2016;16(1):188. https://doi.
org/10.1186/s12886-016-0364-4.
43. Srinivasan S. Today’s contact lens materials and designs. Review of
Optometry. 2017;154:36-45.
44. Nichols J, Willcox M, Bron A, et al. The TFOS international
workshop on contact lens discomfort: executive summary. Invest
Ophthalmol Vis Sci. 2013;54(11):TFOS7-TFOS13.
45. Azar D, Azar N, Brodie S, et al. Clinical refraction. In: Cantor
L, Rapuano C, Cioffi G, eds. Clinical Optics. San Francisco, CA:
American Academy of Ophthalmology; 2015:120-125.
46. Boroyan HJ, Cho MH, Fuller BC, et al. Lined multifocal wear-
ers prefer progressive addition lenses. J Am Optom Assoc.
1995;66(5):296-300.
Overview of Presbyopia and Its Medical Management   17
47. Charman WN. Developments in the correction of presbyopia I: spec-
tacle and contact lenses. Ophthalmic Physiol Opt. 2014;34(1):8-29.
48. Evans BJ. Monovision: a review. Ophthalmic Physiol Opt.
2007;27(5):417-439.
49. Jain S, Arora I, Azar DT. Success of monovision in presbyopes:
review of the literature and potential applications to refractive sur-
gery. Surv Ophthalmol. 1996;40(6):491-499.
50. Johannsdottir KR, Stelmach LB. Monovision: a review of the scien-
tific literature. Optom Vis Sci. 2001;78(9):646-651.
51. McGill E, Erickson P. Stereopsis in presbyopes wearing monovision
and simultaneous vision bifocal contact lenses. Am J Optom Physiol
Opt. 1988;65(8):619-626.
52. Chapman GJ, Vale A, Buckley J, Scally AJ, Elliott DB. Adaptive gait
changes in long-term wearers of contact lens monovision correc-
tion. Ophthalmic Physiol Opt. 2010;30(3):281-288.
53. Josephson JE, Caffery BE. Monovision vs. aspheric bifocal contact
lenses: a crossover study. J Am Optom Assoc. 1987;58(8):652-654.
54. Collins M, Goode A, Brown B. Distance visual acuity and monovi-
sion. Optom Vis Sci. 1993;70(9):723-728.
55. Westin E, Wick B, Harrist RB. Factors influencing success of
monovision contact lens fitting: survey of contact lens diplomates.
Optometry. 2000;71(12):757-763.
56. Back A, Grant T, Hine N. Comparative visual performance of
three presbyopic contact lens corrections. Optom Vis Sci.
1992;69(6):474-480.
57. Morgan PB, Efron N, Woods CA; International Contact Lens
Prescribing Survey Consortium. An international survey of contact
lens prescribing for presbyopia. Clin Exp Optom. 2011;94(1):87-92.
58. Abdelkader A. Improved presbyopic vision with miotics. Eye
Contact Lens. 2015;41(5):323-327.
59. Renna A, Vejarano LF, De la Cruz E, Alio JL. Pharmacological treat-
ment of presbyopia by novel binocularly instilled eye drops: a pilot
study. Ophthalmol Ther. 2016;5(1):63-73.
60. Patel S, Salamun F, Matovic K. Pharmacological correction of pres-
byopia. Poster presented at: XXXI Congress of the ESCRS; 2013;
Amsterdam, the Netherlands.
61. Angelucci DD. Presbyopia eye drop targets miosis and accommoda-
tion. Refractive Surgery Outlook. https://www.isrs.org/resources/
february-2016. Published February 2016. Accessed May 28, 2018.
62. Benozzi J, Benozzi G, Orman B. Presbyopia: a new potential phar-
macological treatment. Med Hypothesis Discov Innov Ophthalmol.
2012;1(1):3-5.
63. Lipner M. A unique drop. Eyeworld. https://www.eyeworld.org/arti-
cle-a-unique-drop. Published October 2014. Accessed May 5, 2017.
64. Crawford KS, Garner WH, Burns W. Dioptin: a novel pharmaceuti-
cal formulation for restoration of accommodation in presbyopes.
Invest Ophthalmol Vis Sci. 2014;55(13):3765.
 SECTION TWO
Corneal-Based Treatment
for Presbyopia

Excimer and
Femtosecond LASER for
Treatment of Presbyopia
Tracy Schroeder Swartz, OD, MS, FAAO, Dipl ABO
and Michael Duplessie, MD
It is not surprising that once surgeons enjoyed the
stability and accuracy of keratorefractive procedures for
distance correction, they would desire algorithms for pres-
byopia as well. Presbyopic corneal refractive treatments
such as conductive keratoplasty have proven less successful
and less stable compared to LASIK.1
Myopes enjoy a marked loss of uncorrected near vision
with distance correction. One fear of treating myopic
presbyopic patients with keratorefractive procedures for
distance correction is exposing an accommodative reserve
inadequate for presbyopic demands and, subsequently, dis-
satisfied patients. This is especially true in low myopes who
are accustomed to reading without their glasses. One study
reported increase in add power of 0.5 diopters (D) or more
in 60.4% of patients post-LASIK, and significant correla-
tions between increased add powers, age, and the amount
of power corrected by LASIK.2
Unlike myopes, hyperopes enjoy an improvement in
near vision after keratorefractive distance correction. One
study of aspheric wavefront-guided LASIK in hyperopic
presbyopes reported 100% of patients had achieved bin-
ocular simultaneous uncorrected vision of 20/25 or better
and J3 (Jaeger) at 12 months. Negative spherical aberra-
tion highly correlated with postoperative improvement of
distance-corrected near visual acuity.3
- 21 -
3
Several presbyopic treatments were developed utiliz-
ing the excimer and/or femtosecond lasers. These include
monovision, multifocal, and multizone treatments.
MONOVISION
Monovision is the correction of the dominant eye for
emmetropia, while the nondominant is left myopic, allow-
ing the eyes to see both distance and near. The brain must
learn to alternate dominance and suppress the blur at each
distance for this to be successful.4
Not all patients adapt well to monovision. Monovision
is an imperfect solution due to loss of binocularity. A social
and work history is vital in patient selection. For rigid
personality traits or careers such as engineering, surgeons
should proceed with caution, if at all. Reduced low-contrast
visual acuity, overall contrast sensitivity, stereopsis, small-
angle esotropic shift, and problems performing daily tasks
that require good depth perception have been reported with
monovision correction.5
Monovision should be demonstrated using a trial frame
or contact lenses in patients without a history of monovi-
sion. If the patient can function comfortably wearing the
trial frame demonstration, he or she typically will adapt
well to monovision after surgery. Successful monovision
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 21-33).
© 2019 SLACK Incorporated.
22  Chapter 3
contact lens wearers do not require an in-office trial, and
the refractive endpoint of their habitual monovision is typi-
cally the target with refractive surgery (Figure 3-1).
The myopic target for the near eye is typically -1.5 D,
depending on age, history of monovision, and typical work-
ing distance. Barisic et al6 reported LASIK monovision
with a 0.5 D to -1.25 D target in the nondominant eye
in patients under 50 years old yielded good vision at all
distances without affecting stereovision. The greater the
degree of image size disparity (aniseikonia), the more dif-
ficult the transition. Barisic et al6 found better distance and
intermediate visual acuity with less glare and halos than
the refractive lens exchange with a multifocal intraocular
lens (IOL) group.
Modified monovision, a myopic correction of -0.75 D,
is sometimes used for those working primarily on a com-
puter. These patients require less accommodative power
compared to a patient with a working distance typical of a
conventional book and inability to change the font.
Patients are typically satisfied with monovision as long
as the distance eye has surgical correction within 0.5 D
of emmetropia.5 Due to the reliance on one eye for each
distance, the enhancement rate is higher with monovision
correction, typically 10% to 17%.5
Success rates reported in the literature vary, as the defi-
nition of success and methodology of testing visual acuity
is not consistent. Rates range from 85% to 97% (Table 3-1).
Advanced algorithms have been used to combine under-
correction, now termed mini-monovision, with multifocal
ablations to increase patient satisfaction.
Presbyond
This technique combines nonlinear aspheric ablation
profiles with micro-monovision, using depth of focus to
extend the range of functional vision at near. The MEL 80
excimer laser (Carl Zeiss Meditec) software uses algorithms
to increase the depth of focus by increasing a specific
corneal aberration Z (4.0). An increased Z (4.0) combined
with small amounts of myopia reduce near myopic blur at
distance and promote pseudoaccommodation with small
pupils due to accommodation.7
The dominant eye is targeted for exactly plano, and
the nondominant eye is targeted for slight myopia. The
ideal target is -1.5 D, although this can be varied between
-0.75 D to -1.75 D depending on age, degree of presbyopia,
and patient tolerance. The increase in depth of field is such
that the ranges of clear vision achieved by the distance and
near eyes overlap at intermediate distances, unlike the tra-
ditional monovision approach in which there is a gap in the
range of clear vision.
Figure 3-2 illustrates the treatment. This 54-year-old
male patient presented with manifest refraction and cor-
rected distance visual acuity (CDVA) of +1.00 -0.25 x 75
(20/16) in the right eye and +0.75 D (20/16) in the left eye.
Presbyond Laser Blended Vision with the MEL 90 excimer
laser and VisuMax femtosecond laser (both by Carl Zeiss
Meditec) was performed using an intended target of -1.5 D
for the right eye and plano for the left eye. One year after
surgery, the patient’s binocular uncorrected visual acuity
was 20/16 + 1 at distance, J2 at intermediate, and J1 at near.
Monocularly, uncorrected distance visual acuity (UDVA)
was 20/63 - 1 in the right eye, slightly better than expected
for the manifest refraction of -1.50 -0.25 x 166 (20/16). In
the left eye, UDVA was 20/16 - 1 with manifest refraction
of 0.00 -0.25 x 64 (20/16). Subjectively, the patient had
adapted to the cross-blur by 3 months and was spectacle
independent. Contrast sensitivity was unchanged from
before surgery.
A study of micro-monovision LASIK in myopic pres-
byopes evaluated 80 eyes of 40 patients, with a mean age of
43.4 years old, treated bilaterally using an aspheric micro-
monovision. Distance eye target was plano while the near
target ranged from -0.75 D to -2.25 D. Ninety-five percent
of patients achieved simultaneous UDVA of 20/20 and
20/25 or better.8
A larger retrospective study by Reinstein et al9 includ-
ed 296 eyes from 148 presbyopes treated using this tech-
nique, aiming for a postoperative refraction between -1.0 D
and -1.88 D. Binocularly, 98% of patients achieved 20/20 or
better UDVA. Ninety-nine percent achieved uncorrected
near visual acuity (UNVA) of J3 or better. No eyes lost 2 or
more lines of best correction and no significant change in
contrast was noted at 6, 12, or 18 cycles per degree.9
MULTIFOCAL ABLATION PROFILES
Multifocal ablation has the intention of correcting both
distance and near vision in presbyopic patients. Various
profiles may be employed. Central presbyopic ablations cre-
ate an elevated central zone to induce reading ability, leav-
ing the periphery for distance vision. In peripheral pres-
byopic ablations, the central cornea is treated for distance,
whereas in the periphery a negative asphericity is created
to increase the depth of field.10 This method is more diffi-
cult, as it requires an excimer laser beam profile capable of
compensating for the loss of energy found with peripheral
ablation.10 These techniques include PresbyMAX (Schwind
Eye-Tech-Solutions GmbH and Co. KG), Supracor, multifo-
cal LASIK, and Intracor.
 Excimer and Femtosecond LASER for Treatment of Presbyopia   23

Figure 3-1. Monovision in an emmetrope. A hyperopic ablation is performed in the nondominant eye to induce myopia. (A)
Preoperative. (B) Postoperative. Note the central elevation. (Reprinted with permission from Clark Chang, OD, MSA, MSc, FAAO.)
24  Chapter 3

TABLE 3-1
SUCCESS RATES WITH SURGICAL MONOVISION CORRECTION
Articles Study Group Success Rate Reported
Levinger E, Trivizki O, Pokroy R, Levartovsky S, 40 patients treated with monovision 85.2%
Sholohov G, Levinger S. Monovision surgery in refractive surgery
myopic presbyopes: visual function and satisfaction.
Optom Vis Sci. 2013;90(10):1092-1097.
Goldberg DB. Laser in situ keratomileusis monovision. 114 LASIK procedures for monovision 96%
J Cataract Refract Surg. 2001;27(9):1449-1455. in myopic and hyperopic patients
Jain S, Ou R, Azar DT. Monovision outcomes in 42 patients who underwent refractive 88%
presbyopic individuals after refractive surgery. surgery for monovision
Ophthalmology. 2001;108(8):1430-1433.
Reilly CD, Lee WB, Alvarenga L, Caspar J, Garcia-Ferrer 82 patients who underwent LASIK 97%
F, Mannis MJ. Surgical monovision and monovision surgery for monovision
reversal in LASIK. Cornea. 2006;25(2):136-138.

Figure 3-2. Presbyond Laser Blended Vision with the MEL 90 excimer laser and VisuMax femtosecond laser was performed
using an intended target of -1.5 D for the right eye and plano for the left eye. One year after surgery, the patient read 20/16 + 1 at
distance, J2 at intermediate, and J1 at near. Contrast sensitivity was unchanged from before surgery. (Reprinted with permission
from Daniel Reinstein, MD.)

PresbyMAX Six-month data on 60 eyes, 20 each of hyperopic, emme-

PresbyMAX uses a central presbyopic ablation
approach to create simultaneous distance and near vision
correction. This uses a bi-aspheric technique employing
a central center area for reading and pericentral distance
correction in hyperopic, emmetropic, and myopic patients.
The ablation profile is shown in Figure 3-3.
tropic, and myopic patients, demonstrated that presbyopic
myopes on average lost mean binocular UNVA, but other
groups maintained satisfactory distance and near vision.11
Luger et al12 reported 1-year results in 31 patients.
Seventy percent of patients achieved uncorrected dis-
tance vision of 0.1 logMAR or better, and 84% obtained
 Excimer and Femtosecond LASER for Treatment of Presbyopia   25

Figure 3-3. (A) PresbyMAX bi-aspheric profile showing the multizone, near vision profile. Frontal view (left). Cross-section (right).
Ablation profiles were optimized by using a predictive model based on a light propagation algorithm. (B) Illustration of how the
PresbyMAX profile creates a depth of focus to allow near and distant vision. (Reprinted with permission from Schwind Eye-Tech-
Solutions GmbH and Co. KG.)

uncorrected near vision of 0.1 logRAD or better. Despite Supracor

impressive results, authors reported some patients reported
difficulty with adaption to the compromise in vision or
were dissatisfied by the minor loss of distance visual acuity.
They recommended a multifocal contact lens trial or trial
frame with a mild defocus to simulate postoperative visual
impression and evaluate patient acceptance.12
A larger study of 358 presbyopia patients treated with
bi-aspheric ablation PresbyMAX with monocular cor-
rected distance vision. At 6 months, 76% of patients had
0.1 logMAR or better uncorrected at distance. Ninety-one
percent of patients obtained an uncorrected near vision
of 0.1 logMAR. However, binocular corrected vision at
distance and near both fell (20/20 to 20/25 at distance and
from 0.2 to 0.047 logRAD at near), indicating the higher
order aberrations created by the treatment.13
Supracor is a presbyopia algorithm that corrects dis-
tance refractive error and presbyopia in a 1-step procedure
using the Technolas 217P or Teneo 317 excimer lasers
(Bausch + Lomb). The Technolas software creates a 12-μm
elevation with negative spherical aberration in the central
3.0-mm zone. The central area is surrounded by an aspher-
ic-optimized midperipheral zone. The central hyperprolate
area extends the eye’s depth of focus (Figures 3-4 and 3-5).
The central area is utilized more as the eye accommodates
and the pupil constricts. When the patient looks at distance,
the pupil dilates and the aspheric-optimized midperipheral
zone allows for distance vision. A target of -0.75 D is recom-
mended to maximize the central near vision area.
26  Chapter 3

Figure 3-4. (A) Pretreatment topography in a 63-year-old patient. Refraction OD: +1.00; Refraction OS: +3.00 -0.75 x 175. Planned near
addition: +1.5 D with Amaris 500 laser (Schwind Eye-Tech-Solutions GmbH and Co. KG). The ablation profile was centered in the corneal
vertex. (B) Post-PresbyLASIK treatment demonstrating central steepening at 6 months. Postoperative refraction OD: +0.50 -1.00 x 5
(20/20); OS -1.00 -1.00 x 175 (20/25). Binocular unaided distance vision was 0.9 (20/25+) and J1 at near. (Reprinted with permission from
Jorge L. Alio, MD, PhD.)
 Excimer and Femtosecond LASER for Treatment of Presbyopia   27

Figure 3-5. (A) Preoperative topography in a 45-year-old male myope. Preoperative manifest refraction was
-2.5 D. UDVA was 20/200; uncorrected intermediate visual acuity (UIVA) was 20/50; UNVA was J1. (B) Postoperative
topography following myopic Supracor. One-month postoperative manifest refraction was -0.50 -0.50 x 160. UDVA
was 20/25, UIVA was 20/20, and UNVA was J1. (Reprinted with permission from Robert Ang, MD.) (continued)
28  Chapter 3

Figure 3-5 (continued). (C) Preoperative topography in a 47-year-old male hyperope. Manifest refraction +1.25
-0.50 x 175. UDVA was 20/25, UIVA was 20/40, and UNVA was J6. (D) Postoperative topography 1-month status
post hyperopic Supracor. Postoperatively, the manifest refraction was -0.50 -0.25 x 150. UDVA was 20/25, UIVA was
20/25, and UNVA was J1. (Reprinted with permission from Robert Ang, MD.)
 Excimer and Femtosecond LASER for Treatment of Presbyopia   29
Saib et al14 reported results with hyperopic presby-
opes treated using central presbyopic LASIK with induced
micro-monovision using the Technolas 217P excimer. They
evaluated 74 eyes of 37 patients. The mean postopera-
tive spherical equivalent refraction was 0.0 D ± 0.58 D in
the dominant eyes and 0.51 D ± 0.54 D for nondominant
(near corrected) eyes. The mean central steep zone was
2.35 D ± 1.0 D. There was significantly more negative spher-
ical aberration and vertical coma in the central 5.0 mm
postoperatively (P < .05).14 Another report of 23 patients
(46 eyes) receiving bilateral LASIK with a multifocal cor-
neal ablation profile at 6 months found 6% of patients lost
2 or more lines of best-corrected vision, although 100%
did maintain a CDVA of 0.2 logMAR or better. Ryan and
O’Keefe15 suggested a -0.5 D target in the nondominant eye
is helpful for patient satisfaction.
Doyle et al16 reported retreatment rates using Supracor.
Thirty-eight patients (76 eyes) were treated. Forty-two per-
cent of patients (16 patients) who underwent the Supracor
procedure initially required at least one further correc-
tive procedure. Mean follow-up time was 12 months.16 Six
months after the primary treatment, 7 eyes lost 1 line of
Snellen CDVA and 1 eye lost 2 lines compared to preopera-
tive corrected visual acuity. After all retreatments, 9 eyes lost
1 line, and 2 eyes lost 2 lines compared to preoperative cor-
rected visual acuity. Mean unaided distance acuity after pri-
mary treatment was 20/25.8 at 6 months and was unchanged
after retreatments. Six months after the primary treatment,
the UDVA was 20/30 or better in 92% of eyes and dropped
to 91% after all treatments. The high enhancement rate and
loss of best-corrected vision was theorized to be related to the
small blend zone (due to the tissue sparing algorithm used),
the hyperpositive central zone, and pupil centration.16
Progressive Multifocal LASIK
(WaveLight Q Factor Modulation)
Progressive multifocal LASIK utilizes LASIK to create
a multifocal or aspheric cornea. Increasing prolateness, or
negative Q value, increases negative spherical aberration
resulting in an increased depth of focus. Essentially, a myo-
pic treatment is performed followed by an equal hyperopic
treatment.
A retrospective study of 102 patients treated using pro-
gressive multifocal LASIK with the WaveLight Allegretto
platform (Alcon Laboratories, Inc) reported 3-month
results. After surgery, 81% of patients had 20/20 or better
binocular UDVA. Ninety-eight percent had 20/25 or bet-
ter binocular UDVA. Additionally, 44% of patients had J1
binocular near visual acuity, 60% had J2, and 96% had J3.17
Wang Yin et al18 reported results on hyperopic patients
treated using central presbyopic LASIK where the domi-
nant eye was treated using standard algorithms for dis-
tance, while the nondominant eye was treated for near
Figure 3-6. Axial map of a cornea status post CustomVis treatment
multizone. The inner far zone is not visible, probably because the
topographer did not have the resolution in the center detect this. The
near zone is visible as a change over most of the optical zone, which was
larger than the hyperopic correction programmed.
using a Q factor modulation. One hundred thirty eyes of
69 patients were treated. At 1 year, mean binocular UDVA
was 20/20. Mean binocular UNVA was J2, and the mean
binocular UIVA was 20/20. As expected with a hyperopic
treatment, the mean keratometry value was statistically
higher in nondominant eyes than the mean K in dominant
eyes (45.85 D ± 1.47 D vs 43.93 D ± 1.77 D; P = .002). More
than 95% of patients were satisfied 3 months after surgery,
and at 6 months, 100% of patients said they would recom-
mend the procedure.18
CustomVis Multizone
Presbyopia Treatment
The Pulzar Z1 (CustomVis) solid state laser presbyopia
software utilizes a treatment plan with 3 zones: central far
vision zone, intermediate near vision zone, and peripheral
far vision zone. The platform algorithms aim to provide
smooth transition between the zones, with minimal corneal
tissue removal. The dominant eye is treated for distance
vision, and the nondominant eye receives the multizone
presbyopia treatment (Figure 3-6).
A study of 36 patients reported 12-month data.
Preoperatively, UNVA was an average 20/72.5.
Postoperatively, 100% of the patients achieved near vision
of 20/40 or better, with 89% achieving 20/30 or better and
58% achieving 20/20. Average postoperative near vision was
20/22.9.
Initial UDVA was on average 20/28. Ninety-two per-
cent of patients were 20/40 or better at distance. After the
PresbyLASIK treatment, nearly 82% of patients maintained a
distance vision of 20/40 or better. Average uncorrected visual
acuity was 20/34.
30  Chapter 3
TABLE 3-2
INTRACOR RESULTS AT 36 MONTHS
Small Inner Ring Diameters Group A:
1.8-mm Inner Ring
Median UNVA 0.7 logMAR improved to
-0.1 logMAR
UDVA 0.1 logMAR to 0.2 logMAR
Losses of 2 lines of 0 eyes
binocular CDVA
Median spherical Preoperative: +0.75 D
equivalent change Postoperative: -0.19 D
Khoramnia R, Fitting A, Rabsilber TM, Thomas BC, Auffarth GU, Holzer MP. Intrastromal femtosecond laser surgical compensation of presbyopia
with six intrastromal ring cuts: 3-year results. Br J Ophthalmol. 2015;99(2):170-176. doi: 10.1136/bjophthalmol-2014-305642.
Intracor Femtosecond
The VICTUS femtosecond laser system (Bausch +
Lomb) rather than an excimer laser is used with this tech-
nique. An intrastromal pattern is used to induce a local
change of the corneal shape. A series of 5 cylindrical rings
are created in the posterior stroma between 2.0 and 4.0 mm
from the line of sight, extending anteriorly toward but not
up to Bowman’s membrane. This creates central steepen-
ing in the pattern of a multifocal hyperprolate and move-
ment of the corneal center forward, rather than an area of
steepening centrally. Advantages of this procedure include
no flap creation and no ablation, which may be better for
patients with dry eye. The refractions are stable, and the
procedure is quick, about 20 seconds. Reportedly, there is
little pain, and visual recovery is quick.19
Khoramnia et al20 reported 36-month results of a
modified Intracor femtosecond laser–based intrastromal
procedure on 20 eyes of 20 hyperopic patients. The Intracor
procedure was performed with a modified pattern of 6
concentric intrastromal ring cuts. Three subgroups based
on 3 different small inner ring diameters (1.8/2.0/2.2 mm
[Groups A/B/C]) were compared. Results are listed in Table
3-2. Overall patient satisfaction with the procedure was
80%, but the authors reported the possibility of reduced
CDVA requires careful patient selection.20
Thomas et al21 reported results from 20 eyes of 20
emmetropic patients treated with a modified intrastromal
Intracor pattern consisting of 5 central rings and 8 radial
cuts. Twelve months postoperative median values revealed
a significant improvement in UNVA from 20/80 to 20/25.
A significant decrease in CDVA of a median loss of 1 line
(P = .0005). Fifteen percent of eyes lost 2 lines of CDVA.
Group B: Group C:
2.0-mm Inner Ring 2.2-mm Inner Ring
0.7 logMAR improved to 0.7 logMAR improved to
0.1 logMAR 0.1 logMAR
0.2 logMAR to 0.3 logMAR 0.1 logMAR to 0.1 logMAR
(no change)
25% of eyes 0 eyes
Preoperative: +0.75 D Preoperative: +0.75 D
Postoperative: +0.13 D Postoperative: -0.19 D
COMPLICATIONS WITH
MULTIFOCAL TREATMENTS
Any near vision procedure is performed at the expense
of distance vision. Problems with centration of central
elevation resulting in loss of best-corrected distance visual
acuity, increased higher order aberrations,22 loss of con-
tract sensitivity,23 and increased night glare have been
reported (Figure 3-7). Regression of the central corneal
elevation and subsequently, reading vision. Irregular astig-
matism resulting from a multifocal ablation can increase
problems with IOL calculation after multifocal laser treat-
ment. Multifocal IOL implantation is not recommended.24
Previous satisfaction of the PresbyLASIK procedure may
not be maintained after phacoemulsification. IOL power is
difficult as the multifocal ablation directly affects topog-
raphy, making IOL calculations difficult. Those patients
suffering from higher order aberrations due to significant
corneal astigmatism will not experience improvement
after cataract surgery and must be educated about this.
Monofocal neutral-aspheric IOLs are recommended, and
lens exchanges are more likely.25
Corneal ectasia following intrastromal presbyopia sur-
gery has been reported in a patient who underwent hyper-
opic LASIK twice followed by bilateral femtosecond laser
intrastromal presbyopia correction. Shortly afterward, the
distance vision decreased and a bilateral central corneal
protrusion was noted upon topography. Imaging revealed
the intrastromal incision crossed the LASIK interface
resulting in dehiscence of the stromal bed.26 Ectasia has
also been reported in a patient who underwent Intracor fol-
lowed by Supracor.27
 Excimer and Femtosecond LASER for Treatment of Presbyopia   31

Figure 3-7. (A) This patient underwent an off-label treatment for presbyopia using a VISX laser (VISX Inc) and was
not able to read. A second treatment was performed, which left her 20/50 best corrected at distance, 20/70 at near,
and unhappy. Note inferior steepening in each eye. (B) Corneal higher order aberrations are predominantly coma,
while the internal aberrations are coma and trefoil. Inferior-superior = 1.71 D, and the best-corrected vision with
spectacles was reduced. (continued)
32  Chapter 3
Figure 3-7 (continued). (C) The left eye shows slightly less coma, but a complicated residual refractive error.
Correction failed to yield 20/20 vision or resolution of the visual distortion.
Retreatments may be requested by dissatisfied
patients.28 Refractive enhancement, with adjustment of
the patient’s current manifest refraction using standard or
topographically guided treatment, may be required. The
goal is to put the manifest refraction in a more visually
comfortable place, with most likely reduction of the near
vision. Multifocal enhancement, where the laser ablation
is a second multifocal ablation, is risky due to the resulting
irregular astigmatism.
REFERENCES
1. Ayoubi MG, Leccisotti A, Goodall EA, McGilligan VE, Moore TC.
Femtosecond laser in situ keratomileusis versus conductive kera-
toplasty to obtain monovision in patients with emmetropic pres-
byopia. J Cataract Refract Surg. 2010;36(6):997-1002. doi: 10.1016/j.
jcrs.2009.12.035.
2. Tsuneyoshi Y, Negishi K, Saiki M, Toda I, Tsubota K. Apparent pro-
gression of presbyopia after laser in situ keratomileusis in patients
with early presbyopia. Am J Ophthalmol. 2014;158(2):286-292.
3. Jackson WB, Tuan KM, Mintsioulis G. Aspheric wavefront guided
LASIK to treat hyperopic presbyopia: 12 month results with the
VISX platform. J Refract Surg. 2011;27(7):519-529.
4. Handa T, Mukuno K, Uozato H, et al. Ocular dominance and
patient satisfaction after monovision induced by intraocular lens
implantation. J Cataract Refract Surg. 2004;30(4):769-774.
5. Levinger E, Trivizki O, Pokroy R, Levartovsky S, Sholohov G,
Levinger S. Monovision surgery in myopic presbyopes: visual func-
tion and satisfaction. Optom Vis Sci. 2013;90(10):1092-1097. doi:
10.1097/OPX.0000000000000002.
6. Barisic A, Gabric N, Dekaris I, Romac I, Bohac M, Juric B.
Comparison of different presbyopia treatments: refractive lens
exchange with multifocal intraocular lens implantation versus
LASIK monovision. Coll Antropol. 2010;34(suppl 2):95-98.
7. Reinstein DZ. Advantages of laser-blended vision. CRST Europe.
2009;1:30-32.
8. Zhang T, Sun Y, Weng S, et al. Aspheric micro-monovision LASIK
in correction of presbyopia and myopic astigmatism: early clinical
outcomes in a Chinese population. J Refract Surg. 2016;32(10):680-
685. doi: 10.3928/1081597X 2016062801.
9. Reinstein DZ, Carp GI, Archer TJ, Gobbe M. LASIK for presbyopia
correction in emmetropic patients using aspheric ablation profiles
and a micromonovision protocol with the Carl Zeiss Meditec
MEL 80 and VisuMax. J Refract Surg. 2012;28(8):531-541. doi:
10.3928/1081597X 2012072301.
10. Alio JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with
excimer laser for presbyopia correction. Curr Opin Ophthalmol.
2009;20(4):264-271.
11. Uthoff D, Pölzl M, Hepper D, Holland D. A new method of cor-
nea modulation with excimer laser for simultaneous correction
of presbyopia and ametropia. Graefes Arch Clin Exp Ophthalmol.
2012;250(11):1649-1661.
12. Luger MH, Ewering T, Arba-Mosquera S. One-year experience in
presbyopia correction with biaspheric multifocal central presby-
opia laser in situ keratomileusis. Cornea. 2013;32(5):644-652. doi:
10.1097/ICO.0b013e31825f02f5.
13. Baudu P, Penin F, Arba Mosquera S. Uncorrected binocular per-
formance after biaspheric ablation profile for presbyopic cor-
neal treatment using AMARIS with the PresbyMAX module.
Am J Ophthalmol. 2013;155(4):636-647, 647.e1. doi: 10.1016/j.
ajo.2012.10.023.
14. Saib N, Abrieu-Lacaille M, Berguiga M, et al. Central PresbyLASIK
for hyperopia and presbyopia using micromonovision with the
Technolas 217P Platform and SUPRACOR algorithm. J Refract Surg.
2015;31(8):540-546. doi: 10.3928/1081597X-20150727-04.
15. Ryan A, O’Keefe M. Corneal approach to hyperopic presbyopia treat-
ment: six-month outcomes of a new multifocal excimer laser in situ
keratomileusis procedure. Cataract Refract Surg. 2013;39(8):1226-
1233. doi: 10.1016/j.jcrs.2013.03.016.
16. Doyle FG, Dooley IJ, Kinsella FP, Quigley C. Retreatment rate
following Supracor treatment of hyperopic presbyopia. J Clin Exp
Ophthalmol. 2016;7:601.
17. Gordon M. Presbyopia corrections with the WaveLight Allegretto:
3-month results. J Refract Surg. 2010;26(10):S824-S826.
 Excimer and Femtosecond LASER for Treatment of Presbyopia   33
18. Wang Yin GH, McAlinden C, Pieri E, Giulardi C, Holweck G,
Hoffart L. Surgical treatment of presbyopia with central pres-
byopic keratomileusis: one-year results. J Cataract Refract Surg.
2016;42(10):1415-1423. doi: 10.1016/j.jcrs.2016.07.031.
19. Rabsilber TM, Holzer MP, Auffarth GU. Cataract surgery after
Intracor and Supracor. CRST Europe. http://crstodayeurope.com/
articles/2012-sep/cataract-surgery-after-intracor-and-supracor/.
Published September 2012. Accessed May 30, 2018.
20. Khoramnia R, Fitting A, Rabsilber TM, Thomas BC, Auffarth
GU, Holzer MP. Intrastromal femtosecond laser surgical com-
pensation of presbyopia with six intrastromal ring cuts: 3-year
results. Br J Ophthalmol. 2015;99(2):170-176. doi: 10.1136/
bjophthalmol-2014-305642.
21. Thomas BC, Fitting A, Auffarth GU, Holzer MP. Femtosecond
laser correction of presbyopia (INTRACOR) in emmetropes using a
modified pattern. J Refract Surg. 2012;28(12):872-878.
22. Epstein RL, Gurgos MA. Presbyopia treatment by monocular
peripheral presbyLASIK. J Refract Surg. 2009;25(6):516-523.
23. Alarcon A, Anera RG, Villa C, Jimenez del Barco L, Gutierrez
R. Visual quality after monovision correction by laser in situ
keratomileusis in presbyopic patients. J Cataract Refract Surg.
2011;37(9):1629-1635.
24. Alio JL. Cataract surgery after Presby-LASIK. CRST Europe. http://
crstodayeurope.com/articles/2012-sep/cataract-surgery-after-pres-
by-lasik-2/. Published September 2012. Accessed May 30, 2018.
25. Bellucci R. Cataract surgery after Presby-LASIK. CRST Europe.
https://crstodayeurope.com/articles/2012-sep/cataract-surgery-
after-presby-lasik/. Accessed May 27, 2017.
26. Courjaret JC, Matonti F, Savoldelli M, D’Hermies F, Legeais JM,
Hoffart L. Corneal ectasia after intrastromal presbyopic surgery.
J Refract Surg. 2013;29(12):865-868.
27. Taneri S, Oehler S. Keratectasia after treating presbyopia with
INTRACOR followed by SUPRACOR enhancement. J Refract Surg.
2013;29(8):573-576. doi: 10.3928/1081597X-20130620-02.
28. Braun EH, Lee J, Steinert RF. Monovision in LASIK. Ophthalmology.
2008;115(7):1196-1202.
 4
Presbyopia Correction
With a Small-Aperture Inlay

Jay S. Pepose, MD, PhD and Mujtaba A. Qazi, MD

In this chapter, we discuss the clinical indications

for the small-aperture corneal inlay and provide guide-
lines for state-of-the-art application of this technology in
clinical practice, including postoperative management.
Outcomes data from the US investigational device exemp-
tion (IDE) trial, as well as other recently published reports,
are reviewed. The KAMRA small-aperture corneal inlay
(CorneaGen) is a valuable addition to the practice of a
comprehensive refractive surgeon. It addresses a key need
for patients who desire spectacle independence as they
become presbyopic but have not yet developed cataracts.
Outcomes have been shown to be reliable and repeatable.
The KAMRA inlay has been more widely studied than any
other corneal inlay technology, with nearly 50 reports in the
peer-reviewed literature.1
The KAMRA inlay design has evolved considerably
since the earliest clinical trials and even early commercial
versions of the device. The inlay that was studied in the
US IDE trial and introduced commercially in the United Figure 4-1. The KAMRA inlay has a 1.6-mm central aperture
States reflects those learnings. It is made of polyvinylidene surrounded by an opaque annulus containing 8400 laser-etched
microperforations. (Reprinted with permission from CorneaGen.)
fluoride and nanoparticles of carbon and is 6.0 μm thick.
The device has an overall diameter of 3.8 mm, with a
1.6-mm central aperture surrounded by an opaque annulus also permit 5% light transmission through the inlay. The
(Figures 4-1 and 4-2). pores are arranged in a pseudorandom pattern in order to
The annulus contains 8400 laser-etched microperfo- minimize diffraction issues at night and maximize diffusion
rations ranging in size from 6 to 12 μm to allow water, through the bulk of the inlay annulus, sparing the edges.
CO2/O2 diffusion, and nutrient flow. The microperforations
Wang M, ed.
- 35 - Surgical Correction of Presbyopia: The Fifth Wave (pp 35-44).
© 2019 SLACK Incorporated.
36  Chapter 4
Figure 4-2. The overall diameter of the inlay is 3.8 mm. Here it is shown next to a contact lens, for
comparison. (Reprinted with permission from CorneaGen.)
The KAMRA inlay extends depth of focus by blocking
unfocused peripheral light rays, while isolating the more
focused central and paracentral rays through its central
1.6-mm aperture, thereby narrowing the blur circle. A
comparison of the patient defocus curves in an untreated
presbyopic eye vs a KAMRA inlay-implanted eye reveals an
extended range of vision in the inlay eye (IE), representing
an average 2.5 diopters (D) of functional range of vision
from near to far.
The inlay is intended for implantation in the nondomi-
nant eye only. While this approach may be similar in appli-
cation to monovision, the unique small-aperture design
overcomes the limitations of monovision by preserving
monocular distance acuity and stereopsis.2
PATIENT SELECTION
The ideal KAMRA patient is between 45 to 60 years old,
requires near correction of +1.0 D to +2.5 D, and is motivated
by lifestyle or other factors to be less dependent on reading
glasses. The IE should have at least 500 μm of central corneal
thickness and a stable refraction. The ideal KAMRA can-
didate should have a preoperative distance refraction that
is slightly myopic in the nondominant IE and plano in the
dominant fellow eye. If laser vision correction is required to
achieve these target refractions, there should be sufficient
corneal thickness to accommodate both the excimer laser
ablation and positioning of the inlay. In the United States,
the inlay is indicated for patients with a mesopic pupil of
less than or equal to 6.0 mm. However, one study has shown
no correlation between pre- or postoperative pupil size and
visual acuity after KAMRA inlay implantation.3
It is important to screen candidates for ocular surface
disease. The central cornea should be free of punctate epithe-
lial keratopathy. Lid or tear film problems should be treated
and resolved prior to performing any surgical procedure.
The AcuTarget HD Analyzer (Visiometrics) diagnostic
instrument can be used to identify both tear film instability
and lenticular changes. Presbyopes with early lens opaci-
ties, which can be graded by the Ocular Scatter Index of the
HD Analyzer, are more likely to be dissatisfied following
KAMRA inlay surgery and should be steered toward lens
exchange. Finally, patients with any ocular or systemic dis-
ease that is a contraindication for corneal refractive proce-
dures should be excluded, as should patients with unrealistic
postoperative expectations. In addition, patients with topo-
graphic or tomographic patterns suggestive of forme fruste
keratoconus or corneal ectasia are not suitable candidates.
Post–refractive surgery patients are often highly moti-
vated to maintain (or regain) spectacle independence as
they become presbyopic and can be good candidates for a
KAMRA inlay. Successful KAMRA implantation has been
reported in post-LASIK presbyopes4-6 and in small num-
bers of patients with prior radial keratotomy 7 or phakic
intraocular lenses (IOLs).8

ELEMENTS OF
A KAMRA PROCEDURE
Implantation of the small-aperture inlay is not difficult
and should be well within the skill set of ophthalmic sur-
geons. A state-of-the-art procedure includes implantation
in a carefully constructed pocket in a patient with the tar-
get refraction, appropriate centration of the inlay, and the
appropriate postoperative topical therapy regimen. Each of
these elements is explained in greater detail below.
Pocket Construction
The KAMRA inlay should be implanted in a lamel-
lar pocket at a depth of greater than or equal to 250 μm,
or greater than or equal to 40% of the total corneal depth.
Implantation deep in the posterior two-thirds of the stroma
preserves corneal nerves and positions the inlay in a region
of the cornea with a lower number of keratocytes that can
be potentially activated and transformed into myofibro-
blasts,9,10 thereby reducing the chance of hyperopic shift
and haze. A recent study also demonstrated that eyes in
which the inlay has been implanted in a deep pocket (greater
than 250 μm) achieve better uncorrected near visual acuity
(UNVA) than those with shallower pockets.6 Patients in
the US IDE study with pockets deeper than 250 μm also
had better results than those with less than 250 μm pockets
(Figure 4-3).11
A femtosecond laser should be used to create the
pocket, with the laser settings adjusted to achieve tight
raster spacing. This ensures a smooth lamellar resection,
which provides better quality optics and further reduces the
wound healing response.
In the US IDE trial, subjects with 6 μm x 6 μm spot-line
separation or tighter on the iFS laser (Johnson & Johnson
Vision) had statistically significantly better UNVA and
were more likely to achieve a stable manifest refraction
spherical equivalent (MRSE) at 12 months compared to
those with wider spot-line separation.11
Target Refraction
Experience has shown that depth of focus and patient
satisfaction are greatest with a refraction of at least -0.75 D in
the nondominant, IE and plano in the fellow eye. Although
small-aperture inlays are quite forgiving of residual astig-
matism, correcting astigmatism greater than 0.5 D would
also be expected to improve performance.12 As discussed
next, the inlay may be combined with laser vision correc-
tion to achieve the target refractions.
Presbyopia Correction With a Small-Aperture Inlay   37
Figure 4-3. Intraoperative view of the inlay. (Reprinted with permission
from Tracy Schroeder Swartz, OD, MS, FAAO, Dipl ABO.)
APPROPRIATE CENTRATION
For optimal inlay centration, the HD Analyzer is used
to identify the visual axis and accurately reference it to the
entrance pupil. In most eyes, the inlay should be centered
on the first Purkinje image. For patients with a large angle
kappa (ie, greater than 300 μm distance between pupil
center and first Purkinje), the KAMRA inlay should be cen-
tered midway between the first Purkinje and the coaxially
sighted pupil center (of a constricted pupil).
The small-aperture design is quite forgiving. Centration
within 300 μm of the visual axis seems to be well toler-
ated and has little influence on postoperative visual acuity
for most patients.13 However, if proper centration is not
achieved during the initial surgery, the inlay may be re-
centered to improve visual acuity (Figure 4-4).14
Postoperative Regimen
Adequate postoperative control of the healing response
is essential for long-term success with the KAMRA inlay.
Most surgeons begin with a potent topical corticosteroid,
such as prednisolone acetate 1%, 4 times a day for the first
week, then switch to loteprednol 0.5% or fluorometholone
0.1%, which are less likely to be associated with steroid-
related rise in intraocular pressure on a slowly tapering
schedule over 3 to 4 months.
The ocular surface must also be aggressively managed,
as the inlay’s small aperture amplifies the need for the tear
film to function as an effective refractive surface over the
central cornea. Postoperatively, patients should be encour-
aged to use artificial tears regularly. Many surgeons also
rely on temporary punctal occlusion or prescribe a topical
dry eye medication such as cyclosporine or lifitegrast, along
with oral omega-3 supplementation.
38  Chapter 4
Figure 4-4. (A) Slit lamp image of the inlay. (Reprinted with permission from Nathan Rock, OD, FAAO.) (B) Optical coherence
tomography image of the inlay showing the masking effect outside of the clear 1.6-mm central aperture.
OUTCOMES WITH
THE KAMRA INLAY
The US IDE trial was the pivotal trial that led to the
approval of the KAMRA inlay in the United States. It was
initiated in 2009 and conducted at 24 centers across the
United States, Europe, and Asia, enrolling 508 emmetropic
presbyopes who underwent monocular implantation of the
inlay. To be included in the study, subjects had to be 45
to 60 years old, with MRSE between +0.5 D and -0.75 D,
UNVA worse than 20/40 and better than 20/100, and with
best-corrected distance visual acuity (BCDVA) of 20/20 or
better in both eyes. KAMRA inlays were implanted at a
minimum attempted depth of 200 μm into a femtosecond
laser–created pocket or under a 200-μm flap.
In the course of conducting the IDE trial, it became clear
that the best results could be achieved with a tight spot-line
separation (setting of less than or equal to 6 μm x 6 μm), as
described previously. The following IDE efficacy results are
for the subset (n = 166) of patients who underwent pocket
lamellar resection with tight spot-line separation (less than
or equal to 6 μm x 6 μm, using the iFS femtosecond laser
during the study, although equivalent settings are now pos-
sible on other lasers as well).
EFFICACY AND VISUAL FUNCTION
Visual Acuity
In the IDE trial, there was an average gain of 3 lines of
UNVA 12 months after KAMRA inlay implantation. This
gain remained stable through 60 months postoperatively.
The average change in uncorrected distance visual acuity
(UDVA) was a half-line decrease at 12 months, which also
remained stable for 60 months (Figure 4-5). At 3 years,
mean monocular UNVA was J2 (Jaeger; 20/25) and mean
monocular UDVA was 20/25. Binocularly, the mean UNVA
and UDVA were J2 (20/25) and 20/16. Ninety percent of
subjects achieved J4 (20/32) or better binocular UNVA and
99% achieved 20/32 or better UDVA at 12 months.
 Presbyopia Correction With a Small-Aperture Inlay   39

Figure 4-5. Visual performance data from the IDE study is available out to 5 years. UNVA, both binocular (OU) and in
the IE, improved postoperatively and remained stable through 5 years. Binocular UDVA was unchanged compared to
preoperatively. (Reprinted with permission from CorneaGen.)

Figure 4-6. When paired with a small amount of myopia (-0.75 D), patients can achieve up to 2.75 D of functional depth
of focus, with minimal compromise to distance vision in the IE. (Reprinted with permission from CorneaGen.)

Depth of Focus and Refraction
The extent to which the small-aperture inlay extends
depth of focus is influenced by the refraction in the
implanted eye. Previous experience has shown that eyes
with a -0.75 D refraction can achieve up to 3.0 D of con-
tinuous functional range of vision. The range is reduced in
emmetropic to slightly hyperopic eyes. When the refrac-
tion in the IE is +0.5 D prior to implantation, for example,
patients achieve approximately 1.5 D of continuous func-
tional vision (Figure 4-6).
The depth of focus achieved in the IDE trial closely mir-
rors prior experience as well as the predictions of theoreti-
cal models for depth of focus with a small-aperture inlay.15
In the trial, 91.9% of patients with preoperative myopic
refractions achieved J5 (20/40) or better UNVA vs 76.2%
with preoperative hyperopic refractions.
Contrast Sensitivity
Contrast sensitivity testing was performed on a prede-
termined subset of 327 IDE trial subjects. There was some
decrease in monocular photopic contrast sensitivity post-
operatively and a slightly greater decrease in monocular
mesopic contrast sensitivity. However, the mean contrast
sensitivity in the IEs remained well within normal limits
through 36 months postoperatively and binocular contrast
remained essentially unchanged from preoperative levels.
40  Chapter 4
Figure 4-7. KAMRA inlay subjects had better binocular mesopic contrast sensitivity than subjects implanted with
accommodating or multifocal IOLs. (Reprinted with permission from CorneaGen.)
Contrast sensitivity in the IDE study was compared to the
performance of 78 subjects randomized to bilateral implan-
tation of 1 of 3 leading presbyopia-correcting IOLs: the
Crystalens AO (Bausch + Lomb), ReSTOR +3.0 D multifocal
(Alcon Laboratories, Inc), and TECNIS +4.0 D multifocal
(Johnson & Johnson Vision). KAMRA inlay subjects had
better monocular contrast sensitivity than the multifocal
IOL patients and better binocular contrast sensitivity than
all 3 IOL groups (Figure 4-7).16
Visual Field
Unlike a simple small aperture that completely blocks
light beyond the aperture (and would be expected to affect
the visual field), the KAMRA inlay’s annular ring allows
peripheral light to reach the retina, which helps to maintain
the visual field.17
Visual field testing in the IDE study was performed
with SITA Standard 24-2 perimetry (Carl Zeiss Meditec
Humphrey). Preoperatively, the dominant and nondomi-
nant eyes had similar pattern standard deviation (PSD).
Postoperatively, the mean deviation in the nondominant,
inlay-implanted eyes decreased slightly from -0.217 to -1.234
at 12 months. It remained near this level through 36 months.
Postoperatively, PSD increased slightly for both eyes of
the subjects, with the increase remaining essentially stable
through 36 months. This mean increase in PSD was mini-
mal, indicating that the range of the visual field is not sig-
nificantly changed by the presence of the KAMRA inlay.11
In another study, the extent of the visual field follow-
ing implantation of a small-aperture inlay was assessed
with automated Goldmann kinetic perimetry (Haag Streit
Octopus 900). The inlay did not decrease the extent of the
visual field, as demonstrated by the lack of difference in
total area and extent of kinetic visual field when comparing
the implanted and nonimplanted eyes.18
Stereoacuity
Distance stereopsis was evaluated preoperatively and
at 6 months postoperatively in an IDE substudy of 60 sub-
jects. The KAMRA small-aperture corneal inlay did not
affect stereopsis, which remained within normal limits and
statistically equivalent to preoperative levels (36.1 ± 31.3 vs
35.5 ± 34.7 arc sec).19
Fernandez et al2 demonstrated that combining a small
aperture with -0.75 D monovision improved stereopsis
compared to -0.75 D of traditional monovision.
Patient-Reported Outcomes
A number of studies have demonstrated that patients
are very satisfied with the results of small-aperture inlay
implantation.20-24 It is important to recall that the great-
est depth of focus—and therefore the highest chance of
spectacle independence—requires a slightly myopic IE and
a plano fellow eye. In a study in which patients had a near
emmetropic outcome (mean MRSE -0.1 D, with a range of
-2.0 D to +1.75 D), those patients who had a -0.75 D refrac-
tion in the IE, achieved higher rates of spectacle indepen-
dence and satisfaction.6 In our experience, if patients are
hyperopic in the dominant eye, laser vision correction of
that eye to emmetropia will further enhance the level of
patient satisfaction.

Safety
All subjects in the IDE trial had 20/20 or better BCDVA
before surgery. At all postoperative time points, fewer
than 2.0% of eyes had a loss of 2 or more lines of BCDVA.
The proportion with a loss of 2 or more lines was 1.9%
at 12 months, 1.1% at 24 months, and 0.7% at 36 months.
There was a mean loss of 1 letter of BCDVA over 36 months.
At all times after surgery, approximately 99% to 100% of
subjects had 20/25 or better distance vision. None of the
subjects had BCDVA worse than 20/40.11
During the IDE trial, the following intraoperative com-
plications were reported: debris over inlay (0.2% or 1/508),
debris over inlay with defect in the cornea (0.2% or 1/508),
cells in the inlay pocket with greater than or equal to 2 line
loss in vision (0.2% or 1/508), growth of epithelial cells into
the inlay pocket (0.6% or 3/508), and folds in the inlay (0.2%
or 1/508).
Postoperatively, there were 2 patients in the IDE study
who experienced a focal anterior flap thinning in the trial.
One was secondary to an external insult (paint chip in the
eye over the inlay), and the second was due to multiple folds
in the inlay as a result of surgical implantation. Five percent
of patients in the IDE study experienced a wound healing
response accompanied by a hyperopic shift.
Dual Procedures
Many patients will need laser vision correction along
with a corneal inlay in order to maximize the depth of focus
benefit from the KAMRA inlay. The best way to accomplish
this continues to evolve as more surgeons gain experience
and publish results.
In our opinion, a planned 2-step procedure, with the
laser vision correction procedure performed first under a
thin, femtosecond laser flap, followed by pocket creation
and inlay placement a few weeks later, is ideal. The pocket
should be placed at a depth of 250 μm or greater and at least
100 μm below the flap interface. A staged procedure pro-
vides the surgeon with confidence in the refractive outcome
and centration of the laser vision correction procedure
before attempting the inlay procedure.
On the other hand, a combined, simultaneous pro-
cedure may be more efficient for the surgeon and allow
patients to achieve their desired outcomes more quickly.
There have been several published reports of simultaneous,
dual-procedure outcomes.
Igras et al,20 for example, recently reported 12-month
results from a retrospective chart review of 132 patients who
underwent combined LASIK and KAMRA. In this study,
wavefront-guided LASIK was performed and the inlay was
positioned under a thick (200 μm) flap, rather than in a pock-
et. Patients had a significant and sustained improvement in
UNVA in the IE, from J13 preoperation to J3 or better at the
last follow-up visit, with no effect on binocular UDVA.20
Tomita and Waring21 reported 1-year results of simul-
taneous LASIK and KAMRA, also implanted under the
Presbyopia Correction With a Small-Aperture Inlay   41
LASIK flap, in 277 hyperopic presbyopes. They compared
results for patients in their 40s (Group 1), 50s (Group 2),
and 60s (Group 3). All groups achieved a mean UDVA of
20/20, with gains of 1, 2, and 3 lines of distance vision,
respectively. Mean UNVA was J2 in Group 1 and J3 in
Groups 2 and 3.21
Some surgeons are now performing simultaneous
LASIK with the KAMRA inlay, which involves creating the
pocket and the flap with a femtosecond laser, inserting the
inlay into the pocket, and then performing the laser abla-
tion. This requires confidence in one’s inlay centration, as
a poorly centered inlay could cause the ablation to also be
decentered. It is advisable for there to be a minimum of
100 μm between the depth of the pocket and the flap, to
ensure that these planes are kept separate during the surgi-
cal dissection.
Moshirfar et al25 reported 6-month results after simul-
taneous photorefractive keratectomy (PRK) and KAMRA
inlay in a small number of subjects (n = 12). In this study,
the inlay was placed in a stromal pocket, then alcohol-
assisted PRK was performed. Most patients were within
±0.5 D of the target -0.75 D in the IE and 83% achieved
monocular UNVA of 20/40 or better.25
The longer recovery time of PRK makes it less desirable
for a staged or combination procedure with a corneal inlay.
However, PRK may be an appropriate option in post-LASIK
eyes where a flap lift is undesirable given the increased risk
of epithelial ingrowth and/or uncertainty as to depth of the
previous LASIK flap. PRK may also be considered in eyes
with insufficient corneal tissue to accommodate the flap,
laser treatment, and the 100-μm safety zone between the
flap interface and the inlay pocket, while still maintaining
a residual stromal bed of 250 to 300 μm. Moshirfar et al25
point out that performing the 2 procedures simultaneously
condenses the recovery time and reduces the total length of
steroid treatment.
OVERVIEW OF
POSTOPERATIVE MANAGEMENT
Testing Visual Acuity
Capturing a repeatable refraction in an IE can be chal-
lenging as the increased depth of focus allows patients to
tolerate a wide range of refractive error before noting any
degradation. Autorefractors are not reliable measures of
refraction in an eye implanted with a small-aperture inlay.
To achieve a good refraction in a KAMRA IE, patients
should be tested using a mid-point refraction or red/green
technique. Additionally, testing should be performed in a
well-lit room. Nevertheless, in a substudy conducted under
the IDE clinical trial, the repeatability of refractions within
±0.5 D was 90% vs approximately 95% in the published
literature for noninlay implanted eyes.11
42  Chapter 4
Interpreting Topography in
Postoperative Inlay Eyes
It is recommended that corneal topography should
be obtained both preoperatively, to assist with appropriate
patient selection, and postoperatively, to monitor for sur-
face irregularity due to dry eye syndrome and for signs of
aggressive wound healing. When evaluating topographies,
it is important to take into consideration the scale and color
settings of the readout to avoid overinterpretation.
It is common to see a minor ring-shaped steepening
over the edges of the inlay on axial topography postop-
eratively, but no changes centrally. This finding by itself is
not an indication for modulation of postoperative topical
medications. In a minority of patients, more aggressive
wound healing leads to the appearance of amorphous haze
over the inlay. Resultant corneal steepening over the inlay
induces relative central flattening. This pattern can be seen
as a red ring over the inlay on axial topography and may
be associated with a hyperopic shift on refraction and a
decrease in near vision. This combination of findings is
characteristic of an aggressive wound healing response and
should be treated by increasing the frequency of a strong
topical steroid, such as prednisolone acetate 1% or diflu-
prednate 0.05%. In rare cases where a wound healing reac-
tion is not responsive to steroid therapy, early explantation
is recommended.
If there is a significant disruption in tear film quality
over the inlay annulus, flattening over the KAMRA inlay
may occur, characterized as a blue ring on topography, along
with central steepening and a myopic shift. In such cases,
aggressive dry eye therapy, with punctal plug insertion and
use of topical cyclosporine or lifitegrast, will resolve the
patient’s visual complaints and normalize the topography.
There was a very low incidence of topographic abnor-
malities during the IDE trial. Nearly all of the findings were
transient and resolved with steroid therapy and/or ocular
surface management.
Epithelial Ingrowth
Interface epithelial ingrowth can occur when implant-
ing the KAMRA inlay, although it is extremely rare with
pocket procedures. The incidence of epithelial ingrowth
in the IDE trial was 0.6%. In the event epithelial ingrowth
does occur, depending on the location, it can be success-
fully removed without disturbing the inlay. It can also be
proactively managed through appropriate surgical tech-
nique, such as removing loose epithelium at the tunnel
entry site and taking care to lift the edge prior to inserting
instruments into the pocket.
Performing Other Ocular Assessments
and Treatments
It is possible to perform routine ocular assessments
and even surgical procedures with the inlay in situ. Fundus
photography, optical coherence tomography, visual field
assessment, intraocular pressure measurement, contrast
sensitivity testing, and gonioscopy can all be performed
successfully with the KAMRA inlay in place.24-30
Cataract surgery and Nd:YAG (neodymium: yttri-
um-aluminum-garnet) capsulotomy are possible with the
inlay in place with minimal modification of surgical
technique.28,30-32 Accurate biometry and lens power cal-
culation for inlay implanted eyes using the Lenstar (Haag-
Streit) and SRK/T formula, respectively, have been report-
ed.32 Use of a femtosecond laser for clear corneal incisions,
arcuate incisions, and capsulotomy have been performed
successfully in pig eyes implanted with a KAMRA inlay33;
however, additional study in humans is needed. After
cataract extraction, a monofocal IOL can then be inserted.
Alternatively, the inlay can be removed prior to performing
cataract surgery.
For retinal procedures requiring the use of unfocused
laser photocoagulation (eg, panretinal photocoagulation,
central serous retinopathy, macular edema), the inlay
should be removed prior to treatment to minimize the
potential for damage to the inlay and surrounding corneal
tissue.34 However, there is a report in which surgeons were
able to photograph the peripheral fundus and photocoagu-
late retinal tears while viewing the retina through a wide-
angle contact lens.35 Successful completion of a pars plana
vitrectomy, transscleral cryotherapy, and air-fluid exchange
in a KAMRA eye have been reported.36 Anti–vascular
endothelial growth factor injections, pneumatic retinopexy,
and use of a scleral buckle should also be possible with the
inlay in place.
Inlay Removal
The removable nature of the corneal inlay is one of the
primary advantages of this approach to vision correction.
In the tight femtosecond spot spacing subset of the IDE
trial, the removal rate was 2.9%.11 Inlay removal can be
compared to monovision reversal. According to published
literature, monovision reversal rates range from 1.2% to
7%.37,38 For presbyopia-correcting IOLs, where removal
carries higher surgical risk and limits replacement to a
monofocal IOL, the removal rate is approximately 1.0%.
After removal of the KAMRA inlay, all IDE subjects were
within ±0.5 D of their preoperative MRSE, and all subjects
had at least 20/20 or better BCDVA.
After removal, a faint ring-shaped impression may be
seen on the stromal bed; this is normal and should resolve
over time. In some instances where haze was noted prior to
inlay removal, the haze may persist after removal and delay
the full return of vision.

ADDRESSING PATIENT
CONCERNS OR COMPLAINTS
Complaints and complications stemming from or
associated with implantation of a corneal inlay are few and
manageable.
Dissatisfaction With Visual Acuity
The leading reason for dissatisfaction after inlay
implantation is refractive error. Patients with a refractive
error between -0.75 D and -1.0 D in the IE and plano in
the fellow eye are most likely to achieve great simultaneous
distance and near vision. If the refraction is more hyperopic,
the patient may give up near acuity. Conversely, if the refrac-
tion is more myopic, the patient may give up distance acuity.
Blurry/Fluctuating Vision
In the IDE trial 6% of the patients experienced severe
blurry or fluctuating vision at 12 months. These patients
should be examined in both eyes for changes in refrac-
tion, dry eyes, cataract, and other ocular anomalies. In the
majority of patients, fluctuating vision is primarily associ-
ated with dry eye and is often associated with poor compli-
ance with the prescribed postoperative drop regimen.
Night Vision Symptoms
The incidence of severe glare or halos was less than 3%,
and night vision disturbances were 3% or less at all follow-
up visits in the IDE study.9 The incidence rates for these
symptoms are similar to those experienced by patients
following LASIK. These patients should be examined for
proper inlay centration using a device like the HD Analyzer
diagnostic instrument. In most patients, visual distur-
bances tend to decrease over time with neuro-adaptation.
Therefore, it is important to encourage patients to avoid
comparing the vision between the eyes and educate them
about using proper lighting to improve vision under low-
light conditions.
Dryness
The incidence of severe dry eyes was 5.8% at 12 months
and 5.5% at 36 months in the IDE trial.11 This is consistent
with other studies of corneal refractive procedures where
dry eye is a common postoperative complaint and is gener-
ally well managed with ocular surface treatment.39 It has
been well documented in the published literature that older
patients, postmenopausal women, and patients needing
higher refractive correction have a greater risk for develop-
ing post-LASIK dry eye (P = 0.001).40 These same factors
may influence results with the KAMRA inlay.
Presbyopia Correction With a Small-Aperture Inlay   43
Proactive optimization of the ocular surface prior to
surgery can decrease the incidence and severity of postop-
erative symptoms.
Shadows and Double Vision
In the IDE trial, 1% to 2% of patients experienced
severe shadows and double vision. Patients may report
experiencing shadows and/or double vision if their inlay
is not centered correctly.14 Failure to achieve anticipated
improvements in near vision may also occur. For these
patients, the HD Analyzer diagnostic instrument, or simi-
lar device, should be used to assess the actual inlay position
vs the first Purkinje and pupil centroid and provide guid-
ance for repositioning the inlay. Accurate assessment of
inlay centration is not possible with either a slit-lamp or a
topographer. After successful repositioning, patients have
reported an almost immediate improvement in visual qual-
ity and acuity.14
Failure to Adapt
As with all presbyopia-correcting procedures, neuro-
adaptation can take longer in some patients than others.
Some patients who present with a very strong ocular
dominance may suppress the IE postoperatively, making
adaptation more difficult. Encouraging patients to give
their vision time to improve, practicing reading without
glasses regularly, minimizing the use of reading glasses,
and, in extreme cases, patching the dominant eye can help
the patient through the adaptation process.
CONCLUSION
Broad research and commercial experience with the
KAMRA inlay provides a wealth of resources for under-
standing best practices and expected outcomes in small-
aperture inlay surgery. It is essential that surgeons screen
potential patients well for preoperative dry eye, lenticular
changes, or other contraindications, and perform state-of-
the-art surgery. Specifically, the KAMRA inlay should be
implanted in a deep pocket using a smooth femtosecond
laser technique, appropriate centration, and an extended,
tapering course of postoperative anti-inflammatory therapy.
Best results will be obtained when the correct refractive
targets are achieved. Protocols for combining laser vision
correction and inlay surgery are still evolving, but surgeons
have found success with a number of different approaches.
When these steps are followed, KAMRA inlay patients
can expect to achieve, on average, a 2.5 D range of func-
tional vision, with minimal to no impact on distance vision,
stereopsis, and contrast sensitivity. Complications associ-
ated with this inlay are minimal and can be easily managed
44  Chapter 4
in most cases. Although removal is rarely necessary, the
ease of removal is an advantage of this type of presbyopia-
correcting surgery. Evidence to date continues to suggest
that the small-aperture corneal inlay provides excellent
outcomes, meeting the needs of presbyopes who are not yet
ready for cataract surgery.
REFERENCES
1. Srinivasan S. Corneal inlays for spectacle independence: Friend or
foe? J Cataract Refract Surg. 2016;42(7):953-954.
2. Fernandez EJ, Schwarz C, Prieto PM, Manzanera S, Artal P.
Impact on stereo-acuity of two presbyopia correction approach-
es: monovision and small aperture inlay. Biomed Opt Express.
2013;4(6):822-830.
3. Tomita M, Kanamori T, Waring GO 4th, Huseynova T. Retrospective
evaluation of the influence of pupil size on visual acuity after
KAMRA inlay implantation. J Refract Surg. 2014;30(7):448-453.
4. Tomita M, Kanamori T, Waring GO 4th, Nakamura T, Yukawa
S. Small-aperture corneal inlay implantation to treat presby-
opia after laser in situ keratomileusis. J Cataract Refract Surg.
2013;39(6):898-905.
5. Tomita M, Huseynova T. Evaluating the short-term results of
KAMRA inlay implantation using real-time optical coherence
tomography-guided femtosecond laser technology. J Refract Surg.
2014;30(5):324-329.
6. Moshirfar M, Quist TS, Skanchy DF, Wallace RT, Linn SH, Hoopes
PC Jr. Six-month visual outcomes for the correction of presbyopia
using a small-aperture corneal inlay: single-site experience. Clin
Ophthalmol. 2016;10:2191-2199.
7. Huseynova T, Kanamori T, Waring GO 4th, Tomita M. Small-
aperture corneal inlay in patients with prior radial keratotomy
surgeries. Clin Ophthalmol. 2013;7:1937-1940.
8. Huseynova T, Kanamori T, Waring GO 4th, Tomita M. Small-
aperture corneal inlay in presbyopic patients with prior pha-
kic intraocular lens implantation surgery: 3-month results. Clin
Ophthalmol. 2013;7:1683-1686.
9. Patel S, McLaren J, Hodge D, Bourne W. Normal human keratocyte
density and corneal thickness measurement by using confocal
microscopy in vivo. Invest Ophthalmol Vis Sci. 2001;42(2):333-339.
10. Niederer RL, Perumal D, Sherwin T, McGhee CN. Age-related
differences in the normal human cornea: a laser scanning in vivo
confocal microscopy study. Br J Ophthalmol. 2007;91(9):1165-1169.
11. AcuFocus. KAMRA inlay professional use information. US Food &
Drug Administration. https://www.accessdata.fda.gov/cdrh_docs/
pdf12/p120023d.pdf. Published March 29, 2015. Accessed May 31,
2018.
12. Tabernero J, Artal P. Optical modeling of a corneal inlay in real
eyes to increase depth of focus: optimum centration and residual
defocus. J Cataract Refract Surg. 2012;38(2):270-277.
13. Corpuz CC, Kanamori T, Huseynova T, Tomita M. Two target loca-
tions for corneal inlay implantation combined with laser in situ
keratomileusis. J Cataract Refract Surg. 2015;41(1):162-170.
14. Gatinel D, El Danasoury A, Rajchles S, Saad A. Recentration
of a small-aperture corneal inlay. J Cataract Refract Surg.
2012;38(12):2184-2191.
15. Eppig T, Spira C, Seitz B, Szentmary N, Langenbucher A. A com-
parison of small aperture implants providing increased depth of
focus in pseudophakic eyes. Z Med Phys. 2016;26(2):159-167.
16. Vilupuru S, Lin L, Pepose JS. Comparison of contrast sensitivity and
through focus in small-aperture inlay, accommodating intraocular
lens, or multifocal intraocular lens subjects. Am J Ophthalmol.
2015;160(1):150-162.
17. Atchison DA, Blazaki S, Suheimat M, Plainis S, Charman WN. Do
small-aperture presbyopic corrections influence the visual field?
Ophthalmic Physiol Opt. 2016;36(1):51-59.
18. Brooker ET, Waring GO IV, Vilupuru AS, Sanchez Leon F. Effect of
small aperture intra-corneal inlay on visual fields [ARVO abstract
1391]. Invest Ophthalmol Vis Sci. 2012;53(14):1391.
19. Linn SH, Skanchy DF, Quist TS, Desautels JD, Moshirfar M.
Stereoacuity after small aperture corneal inlay implantation. Clin
Ophthalmol. 2017;11:233-235.
20. Igras E, O’Caoimh R, O’Brien P, Power W. Long-term results of
combined LASIK and monocular small-aperture corneal inlay
implantation. J Refract Surg. 2016;32(6):379-384.
21. Tomita M, Waring GO IV. One-year results of simultaneous laser in
situ keratomileusis and small-aperture corneal inlay implantation
for hyperopic presbyopia: comparison by age. J Cataract Refract
Surg. 2015;41(1):152-161.
22. Dexl AK, Seyeddain O, Riha W, et al. Reading performance and
patient satisfaction after corneal inlay implantation for pres-
byopia correction: two-year follow-up. J Cataract Refract Surg.
2012;38(10):1808-1816.
23. Dexl AK, Seyeddain O, Riha W, et al. One-year visual outcomes
and patient satisfaction after surgical correction of presbyopia
with an intracorneal inlay of a new design. J Cataract Refract Surg.
2012;38(2):262-269.
24. Dexl AK, Jell G, Strohmaier C, et al. Long-term outcomes after
monocular corneal inlay implantation for the surgical compensa-
tion of presbyopia. J Cataract Refract Surg. 2015;41(3):564-575.
25. Moshirfar M, Wallace RT, Skanchy DF, et al. Short-term visual result
after simultaneous photorefractive keratectomy and small-aperture
cornea inlay implantation. Clin Ophthalmol. 2016;10:2265-2270.
26. Carones F. Assessment of the KAMRA inlay using video keratogra-
phy and corneal OCT: 2 year results. Paper presented at: the ESCRS
Annual Meeting; October 5-9, 2013; Amsterdam, Netherlands.
27. Agca A, Demirok A, Celik HU, et al. Corneal hysteresis, corneal
resistance factor, and intraocular pressure measurements in eyes
implanted with a small aperture corneal inlay. J Refract Surg.
2014;30(12):831-836.
28. Seyeddain O, Hohensinn M, Riha W, et al. Small-aperture corneal
inlay for the correction of presbyopia: 3-year follow-up. J Cataract
Refract Surg. 2012;38(1):35-45.
29. Casas-Llera R, Ruiz-Moreno JM, Alio JL. Retinal imaging after cor-
neal inlay implantation. J Cataract Refract Surg. 2011;37(9):1729-1731.
30. Yilmaz OF, Alagoz N, Pekel G, et al. Intracorneal inlay to cor-
rect presbyopia: long-term results. J Cataract Refract Surg.
2011;37(7):1275-1281.
31. Ziaei M, Mearza A. Corneal inlay implantation in a young pseudo-
phakic patient. J Cataract Refract Surg. 2013;39(7):1114-1117.
32. Tan TE, Mehta JS. Cataract surgery following KAMRA presbyopic
implant. Clin Ophthalmol. 2013;7:1899-1903.
33. Rivera R, Linn S, Hoopes P, Mitchell Y. Effects of a femtosecond
laser used during a cataract procedure on a corneal inlay. Invest
Ophthalmol Vis Sci. 2014;55(13):1544.
34. Mita M, Kanamori T, Tomita M. Corneal heat scar caused by pho-
todynamic therapy performed through an implanted corneal inlay.
J Cataract Refract Surg. 2013;39(11):1768-1773.
35. Yokota R, Koto T, Inoue M, Hirakata A. Ultra-wide-field retinal
images in an eye with a small-aperture corneal inlay. J Cataract
Refract Surg. 2015;41(1):234-236.
36. Jabbur N. Sequential retinal detachment and cataract surgery in
a patient implanted with a small-aperture corneal inlay. Poster
presented at: the ESCRS Annual Meeting; September 13-17 2014;
London, England.
37. Reilly CD, Lee WB, Alvarenga L, Caspar J, Garcia-Ferrer F, Mannis
MJ. Surgical monovision and monovision reversal in LASIK.
Cornea. 2006;25(2):134-138.
38. Braun EH, Lee J, Steinert RF. Monovision in LASIK. Ophthalmology.
2008;115(7):1194-1202.
39. Shoja MR, Besharati MR. Dry eye after LASIK for myopia: Incidence
and risk factors. Eur J Ophthalmol. 2007;17(1):1-6.
40. Nettune GR, Pflugfelder SC. Post-LASIK tear dysfunction and dys-
esthesia. Ocul Surf. 2012;8(3):135-145.

Shape-Changing Inlays
Synthetic Inlays and Allogenic Inlays
Michael Endl, MD; Soosan Jacob, MS, FRCS, DNB;
and Amar Agarwal, MS, FRCS, FRCOphth
Increased demand for visual independence in presby-
opes has triggered medical innovations to attempt to reduce
the need for spectacles or contact lenses. Shape-changing
inlays are implants that alter the shape of the cornea, mak-
ing it more prolate and inducing reading ability. This can be
done with a Raindrop synthetic inlay (ReVision Optics) or
an allogenic corneal graft.
RAINDROP NEAR VISION INLAY
The Raindrop Near Vision Inlay was approved by the
Food and Drug Administration (FDA) to improve near
vision in emmetropic (-0.50 to +1.00 manifest refraction
spherical equivalent [MRSE]) presbyopes; this transparent
inlay changes the shape of the anterior part of the cornea by
creating a hyperprolate shape via biomechanical remodel-
ing of the corneal stroma and epithelium when implanted
under a femtosecond flap. By reshaping the anterior cur-
vature of the cornea, the inlay creates an area of increased
power in the center of the pupil, which gradually decreases
towards the mid-periphery. This zone of power (or profo-
cal cornea) generates a gradient of power, which enhances
near vision, while leaving the peripheral cornea for dis-
tance vision. The smooth transition created by the corneal
epithelium after a Raindrop inlay has been implanted also
- 45 -
5
accounts for low levels of induced visual symptoms, a big
drawback of multifocal intraocular lenses (IOLs) used for
the same purpose (presbyopia correction) when patients
develop cataracts. The safety of the inlay is proven and,
if necessary, can easily be removed. This chapter aims to
summarize the history of hydrogel inlay technology, the
design and mechanism of action, and the peer-reviewed
studies on the safety and efficacy of the Raindrop inlay.
Corneal inlays are a modern modality to provide
improved near vision to patients with presbyopia and
reduce their need for reading glasses. The idea of intracor-
neal inlay implantation started in the late 1940s with testing
of many synthetic materials within the cornea; however,
many proved unsuccessful due to lack of biocompatibility.
Then in the 1950s, after extensive animal research studies,
the first clinical trials were performed with a biocompatible
hydrogel material.1
These studies were abandoned due to poor refractive
predictability, variability in inlay parameters such as mate-
rial and dimensions, and issues regarding corneal inflam-
matory response to the inlay. Much of this research involved
implantation using a freehand corneal pocket or freehand
microkeratome flap. With the advancement of femtosecond
laser technology in the 1990s, the ease and predictability of
creating flaps or pockets led to the development of the cur-
rent inlay technologies used today.1
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 45-52).
© 2019 SLACK Incorporated.
46  Chapter 5
Figure 5-1. The size of the Raindrop Near Vision Inlay in comparison to
an eye of a needle. (Reprinted with permission from ReVision Optics.)
Figure 5-3. Slit lamp image of the Raindrop Near Vision Inlay placed
at the center of the pupil in the nondominant eye. (Reprinted with
permission from Nathan Rock, OD, FAAO.)
The Raindrop Near Vision Inlay, developed in 2007, is
made up of a proprietary biocompatible hydrogel composed
of 80% water that has a refractive index similar to corneal
tissue. The material was fabricated to facilitate adequate
nutrient flow while maintaining a barrier against tissue
ingrowth from one side of the implant to another. This
feature leads to trans-implant tissue viability and allows
the implant to be removable or exchanged. Glucose flux
across the Raindrop inlay is almost 10 times higher than
the flux across the lenses used in the previous studies.2 The
Raindrop inlay is substantially smaller and thinner than the
previously developed inlays (Figure 5-1), at approximately
30 μm central thickness, decreasing to about 10 μm thick-
ness at the periphery, and 2.0 mm in diameter (Figure 5-2).
This space-occupying inlay reshapes the anterior cor-
neal surface, creating a hyperprolate region of increased
power, although the inlay itself has no intrinsic power. This
allows the individual to focus on near and intermediate
objects.3 The Raindrop inlay received FDA approval in June
2016. Its approved indication includes implantation at 30%
of the central corneal thickness, with a minimum depth of
Figure 5-2. Schematic showing the Raindrop Near Vision Inlay
dimensions and properties. (Reprinted with permission from ReVision
Optics.)
150 μm and a minimum residual stromal bed thickness of
300 μm. The preoperative central corneal thickness must
be between 500 to 600 μm. The inlay is implanted in the
nondominant eye under an 8.0-mm femtosecond flap and
centered over the light-constricted pupil (Figure 5-3).4 The
inlay comes in a preloaded titanium inserter. After the flap
is opened completely, the inlay inserter is placed on the stro-
mal bed and delivered with the help of a second instrument,
typically the end of a round cannula. The inlay is positioned
over the pupil and allowed to dry for approximately 1 min-
ute before the flap is closed. Patients follow a benzalkonium
chloride–free strong steroid taper for 1 month, followed by
a mild steroid taper for the next 2 months, with preservative
free artificial tears applied as needed.5
The Raindrop inlay’s mechanism of action within the
cornea was studied in 30 subjects implanted with the inlay
using wavefront techniques. The change in the cornea’s
anterior surface elevation is shown in Figure 5-4 using an
iTrace Visual Function Analyzer (Tracey Technologies).
The change in epithelial thickness after inlay implantation
was measured using optical coherence tomography (OCT;
Optovue Inc) and displayed epithelial thinning centrally
with peripheral thickening (Figure 5-5). The difference
between the inlay thickness and the resulting elevation
change is attributed to attenuation of the effect by the much
thicker flap and epithelial remodeling. This remodeling
extends the inlay effect to about twice the inlay diameter
with the resulting anterior corneal height change providing
about 5.0 diopters (D) of refractive add power at the center
of the pupil, extending to 0.25 D at the 4.0-mm diameter
(Figure 5-6). This central elevation results in improved near
and intermediate vision.6
The first 20 presbyopic patients implanted with the
Raindrop inlay as part of a research study experienced
improved near vision by 1 week postoperative, with all
patients achieving an uncorrected near visual acuity
(UNVA) of 20/40 or better. At 12 months postoperative, all
patients had a UNVA of 20/32 or better for the inlay eye, the
mean uncorrected distance visual acuity (UDVA) for the
inlay eye was better than 20/32, and the binocular distance
vision was better than 20/20. There was a low incidence of
ocular and visual symptoms. All subjects were “satisfied”
or “very satisfied” with the overall visual outcome of the
 Shape-Changing Inlays: Synthetic Inlays and Allogenic Inlays   47
Figure 5-4. Axial map from iTrace software (Tracey Technologies) showing an increase in D at the center of the cornea after inlay implan-
tation. (Reprinted with permission from ReVision Optics.)
Figure 5-5. OCT before and after inlay implantation within the cornea.
The inlay appears as a dark area within the stroma.
Raindrop procedure. The subjects also reported low visual
symptoms; only 11% of Raindrop subjects have moderate
or worse visual symptoms 12 months after implantation.7
Steinert et al3 analyzed 188 patients implanted with the
Raindrop inlay in the nondominant eye. The center-near
power profile forms in-focus near images, with continuous
annular regions providing natural intermediate to distance
zones. In the inlay eye, mean UNVA was 20/25, mean
uncorrected intermediate visual acuity (UIVA) was 20/25,
and mean UDVA was 20/32 postoperatively. Binocularly all
subjects were 20/25 or better at distance. The inlay induces
a continuous center-near power profile and provides good
visual acuity and performance over a 2.0 D range of pre-
operative refraction (ideally -0.5 D to +1.5 D preoperative
refraction). Near task performance was improved signifi-
cantly in good and dim lighting conditions compared to
preoperative measurements.3
Figure 5-6. The mean change in anterior corneal surface height and
the axial power induced by the surface change. Error bars represent one
standard deviation.
In a subset of 30 patients from the pivotal US clinical
trial, the mean reading add had a reduction of 1.6 D. At
1 year postoperative, the average distance-corrected near
acuity improved by more than 3 lines, with patients achiev-
ing 20/40 or better of distance-corrected acuity across
a 3.5 D defocus range. Ninety-seven percent of patients
had a binocular uncorrected visual acuity of 20/32 at dis-
tance, intermediate, and near. There was not a significant
change in binocular contrast sensitivity, and satisfaction
was high.8 Another study looked at high-order aberrations
after Raindrop implantation. Only spherical aberration was
significantly changed after implantation, and this optical
effect was quantified using the vector surgically induced
refractive change calculation, showing that increased depth
of focus and improvement of near vision was attributed to
increased negative spherical aberration.9
48  Chapter 5
Figure 5-7. Example of a patient’s refractive maps derived from corneal
topography preoperatively and 3 months postexplant.
Figure 5-9. Graph showing the mean change in MRSE between
different postoperative visits. Error bars represent 95% confidence
intervals.
As part of the US investigational device exemption
clinical study, safety and efficacy clinical outcomes at
12 months showed mean UNVA exceeded 20/20 from 3
months onward, whereas 99% of subjects had a UNVA of
20/50 or worse preoperatively. Mean intermediate vision
was 20/25 from 1 month through 12 months. Distance
vision slightly decreased from 20/20 to 20/25, but mean
binocular distance vision was 20/20 or better at all visits.
Loss in contrast sensitivity occurred at the highest spatial
frequency but without loss binocularly. More than 95% of
subjects had absent or mild visual or ocular symptoms.
Inlay exchange occurred in 18 cases due to decentration
Figure 5-8. The mean change in acuity at 24 months compared to
preoperative for near, intermediate, and distance vision in the inlay eye
as well as binocular distance vision.
Figure 5-10. Defocus curve of the nondominant eye preoperative and 1
year postoperative. Error bars represent one standard deviation.
and 11 cases required explantation. One hundred percent
of subjects achieved corrected distance visual acuity of
20/25 or better by 3 months postexplant, with an example
of a patient returning to preoperative state postexplant as
shown in Figure 5-7.10
Data on patients from the FDA clinical trial at 24
months revealed similar efficacy results to 12 months.4
Overall, UNVA improved by about 5.0 lines, UIVA
improved by about 2.5 lines, and UDVA decreased by about
1.2 lines (Figure 5-8). Refractive stability was achieved
within 6 months postoperative (Figure 5-9). In a subset
of 30 subjects, a defocus curve test performed preopera-
tively and 12 months postoperatively, showed a flatter defo-
cus curve with negative defocus after inlay implantation
(Figure 5-10).
A surgical subgroup that followed the recommended
treatment parameters and surgical technique, according to
the labeling, revealed better safety outcomes compared to
the full cohort. When haze rates were compared between
flaps thinner than 30% central corneal thickness, flaps
thicker than 30% central corneal thickness, and the surgical
subgroup that had 30% thickness as well as a postoperative
3-month steroid regimen, the haze rates were lower in this
surgical subgroup (Figure 5-11). The overall explant rate
was also reduced from 7.2% in the full cohort to 3.7% in the
surgical subgroup, with only one subject explanted for haze
 Shape-Changing Inlays: Synthetic Inlays and Allogenic Inlays   49
Figure 5-11. Graph showing incidence of corneal haze in the full cohort, at different flap depths, and
in the surgical subgroup.
in this subgroup. All patients that were explanted returned
to baseline levels (see example topography, Figure 5-7), with
all having 20/25 or better best-corrected distance visual
acuity postexplant.
The safety and efficacy of Raindrop inlay implanta-
tion with concurrent LASIK treatment (which is at present
off-label in the United States) has also been studied. In an
analysis of hyperopic presbyopes,11 the target refraction
for the LASIK treatment in the Raindrop inlay eye was
slightly hyperopic (+0.0 D to +0.5 D). This differs from the
refractive target of a KAMRA inlay (CorneaGen), which
tends to be slightly myopic.12 After Raindrop implanta-
tion, the monocular UNVA results were similar to the
emmetropic study, but the UDVA was slightly lower at
the early postoperative visit and improved from 1 month
to 6 months and later, with an average close to 20/32. All
patients were “satisfied” or “very satisfied” at 12 months
postoperatively, with no subject reporting visual symptoms
above mild. Garza and Chayet13 compared 30 patients who
received bilateral myopic LASIK with the Raindrop inlay
implanted in the nondominant eye concurrently. The mean
binocular UDVA, UIVA, and UNVA were better than 20/25
at all postoperative visits. A patient questionnaire at 1 year
postoperative revealed that the visual symptoms were at
the same level as they were preoperatively. Ninety-eight
percent of all visual tasks could easily be performed without
correction, and 90% of patients were satisfied with their
overall vision. In these studies, corneal inlay implantation
with concurrent LASIK was safe and effective for treating
myopic or hyperopic presbyopia.
Studies also showed that the Raindrop inlay does not
interfere with other ocular surgical procedures, such as
IOL implantation. In a 2-case study, femtosecond laser–
assisted cataract surgery was performed with the inlay
present. Due to its transparency, the inlay did not interfere
with visualization of ocular structures and did not require
additional surgical techniques. IOL power calculations
were accomplished normally, except for pre-inlay keratom-
etry values inputted manually. The monofocal IOLs were
targeted for plano, and both patients experienced improved
distance while retaining near vision improvement due to
the inlay.14 Another case series involved implantation with
an intraocular contact lens after the Raindrop procedure.
Likewise, the inlay in place did not have an impact on the
surgical procedure; however, it was important to properly
size and calculate the lenses, as well as ensure minimal
intraocular manipulation to prevent early postoperative
corneal edema.15
In many clinical studies, the Raindrop Near Vision
Inlay has proven effective by changing the shape of the cor-
nea in order to improve near vision in presbyopic patients.
Correction of vision by means of ocular implant is a com-
mon surgical practice. In the case of Raindrop, the improve-
ment of near vision is accomplished by implantation of the
device under a femtosecond laser flap to create a prolate-
shaped cornea. The increase in the curvature of the central
part of the anterior corneal surface corrects presbyopia by
enabling viewing of distant objects through the thinner
portion of the inlay, while near objects are viewed clearly
through the central curved part of the cornea. These effects
have been shown to be consistent to improved over several
2-year investigations. Lastly, with the Raindrop inlay being
a stable corneal presbyopic procedure, its benefits may
be maintained with future intraocular procedures, such
as cataract extraction and IOL placement. Unfortunately,
Revision Optics ceased operations in early 2018.
ALLOGENIC REFRACTIVE LENTICULE
The use of allogenic inlays for presbyopia was first
described by Soosan Jacob and she coined the term,
PrEsbyopic Allogenic Refractive Lenticule or PEARL for
this.16 The PEARL inlay has the advantage of being cre-
ated out of allogenic tissue. It therefore has advantages of
biocompatibility and good integration into the cornea. It
avoids problems secondary to implantation of synthetic
material in the cornea while allowing unhindered passage
50  Chapter 5
Figure 5-12. (A) SMILE lenticule spread out and dried. (B) PEARL lenticule fashioned. (C) Coaxially sighted light reflex marked. (D)
Femtosecond laser–assisted pocket created. (E) PEARL lenticule inserted. (F) PEARL lenticule seen well centered.
of oxygen and nutrients. Stable corneal conditions are thus
ensured with decreased risk of corneal haze necrosis and
melt. As with synthetic corneal inlays, it retains advantages
of reversibility and adjustability. Placement of synthetic
material within the corneal stroma can lead to inflam-
mation, interference with nutritional diffusion into the
anterior stroma above the implant, haze, melt, necrosis, and
peri-inlay deposits.17-21
The lenticule from a healthy screened individual
undergoing femtosecond laser–assisted small incision len-
ticule extraction (SMILE) refractive surgery for myopic
correction is marked to allow later identification of side
and then stored in corneal storage medium for later use.
Before implantation, the stored SMILE lenticule is spread
out with the anterior side facing upward, dried gently with
a surgical sponge, and punched centrally to create a 1.0-mm
disc of allogenic tissue. An average central lenticular thick-
ness of between 65 to 70 μm is suitable. On the presbyopic
patient’s eyes, the coaxially sighted light reflex is then
marked on the cornea at the slit lamp. Next, the femto-
second laser is used to create a pocket at 120-μm depth in
the patient’s eye. The previously prepared PEARL inlay is
implanted into the femtosecond laser–created pocket under
the inked mark. Implantation is easily done with forceps.
Centration is verified through the surgical microscope
as well as immediately postoperatively with an Orbscan
(Bausch + Lomb; Figures 5-12 and 5-13 and www.youtube.
com/watch?v=8H4Ns1b8L3M).
The PEARL inlay steepened the central anterior cor-
neal surface, resulting in a hyperprolate corneal shape
and improved depth of focus. In our studies, there was an
improvement in near vision between 3 to 5 lines and an
improvement in reading speed. Similar to other inlays, the
PEARL inlay gave very good uncorrected near and interme-
diate vision in the operated eye with a slight decrease in dis-
tance vision. However, being only 1.0 mm in size, the effect
on distance vision was low. Night vision symptoms were
minimal and generally not significant enough to interfere
with driving. However, all patients should be warned of
these possibilities in the preoperative period and the inlay
should be implanted in the nondominant eye similar to
other corneal inlays.
The PEARL inlay is invisible to the naked eye. This
is an advantage in light-colored eyes over current pinhole
aperture inlays. The PEARL inlay also creates no interfer-
ence with fundus evaluation or autoperimetry. For patients
with coexisting refractive error, simultaneous LASIK may
be done under a flap followed by implantation of the
PEARL lenticule as described earlier.
A potential disadvantage of this technique is the risk
of stromal rejection from donor tissue. This, however, was
not seen by us. The use of low dose postoperative steroids
for about 4 months, the minute antigenic load of pure
corneal stroma (without the more antigenic epithelium or
endothelium) transferred that may be too small to provoke
a reaction in the immunologically privileged cornea, as well
 Shape-Changing Inlays: Synthetic Inlays and Allogenic Inlays   51
Figure 5-13. (A) Small 1.0-mm PEARL inlay seen in pseudophakic nondominant eye. (B) Postoperative Orbscan showing central
hyperprolate area. (C) Anterior segment OCT showing well-centered intrastromal inlay.
as the more rapid repopulation of the PEARL inlay from all
sides by the patient’s own keratocytes all possibly play a part
in decreasing immunogenicity further.
SMILE lenticule reimplantation has been done previ-
ously in both animal models as well as in patients with
hypermetropia, aphakia, and keratoconus with favorable
efficacy and safety profile.22-27 In the future, complete
femtosecond preparation of prescreened allogenic lenticules
together with cryopreservation for long-term storage will
allow this technique to be more applicable universally even
in centers without the facility for SMILE refractive surgery.
REFERENCES
1. Binder PS, Lin L, van de Pol C. Intracorneal inlays for the correction
of ametropias. Eye Contact Lens. 2015;41(4):197-203. doi:10.1097/
ICL.0000000000000128.
2. Pinsky PM. Three-dimensional modeling of metabolic species
transport in the cornea with a hydrogel intrastromal inlay. Invest
Ophthalmol Vis Sci. 2014;55(5):3093-3106. doi:10.1167/iovs.13-13844.
3. Steinert RF, Schwiegerling J, Lang A, et al. Range of refractive
independence and mechanism of action of a corneal shape-chang-
ing hydrogel inlay: results and theory. J Cataract Refract Surg.
2015;41(8):1568-1579. doi:10.1016/j.jcrs.2015.08.007.
4. ReVision Optics. Raindrop Near Vision Inlay professional use
information. US Food & Drug Administration. https://www.access-
data.fda.gov/cdrh_docs/pdf15/p150034c.pdf. Published July 8, 2016.
Accessed May 31, 2018.
5. Whitman J, Dougherty PJ, Parkhurst GD, et al. Treatment of
presbyopia in emmetropes using a shape-changing corneal inlay:
one-year clinical outcomes. Ophthalmology. 2016;123(3):466-475.
doi:10.1016/j.ophtha.2015.11.011.
6. Lang AJ, Holliday K, Chayet A, Barragan-Garza E, Kathuria N.
Structural changes induced by a corneal shape-changing inlay,
deduced from optical coherence tomography and wavefront mea-
surements. Invest Ophthalmol Vis Sci. 2016;57(9):OCT154-OCT161.
doi:10.1167/iovs.15-18858.
7. Garza EB, Gomez S, Chayet A, Dishler J. One-year safety and effi-
cacy results of a hydrogel inlay to improve near vision in patients
with emmetropic presbyopia. J Refract Surg. 2013;29(3):166-172.
doi:10.3928/1081597X-20130129-01.
8. Whitman J, Hovanesian J, Steinert RF, Koch D, Potvin R. Through-
focus performance with a corneal shape-changing inlay: one-year
results. J Cataract Refract Surg. 2016;42(7):965-971.
9. Whang WJ, Yoo YS, Joo CK, Yoon G. Changes in keratometric
values and corneal high order aberrations after hydrogel inlay
implantation. Am J Ophthalmol. 2017;173:98-105. doi:10.1016/j.
ajo.2016.09.027.
52  Chapter 5
10. Whitman J, Dougherty PJ, Parkhurst GD, et al. Treatment of
presbyopia in emmetropes using a shape-changing corneal inlay:
one-year clinical outcomes. Ophthalmology. 2016;123(3):466-475.
doi:10.1016/j.ophtha.2015.11.011.
11. Chayet A, Barragan Garza E. Combined hydrogel inlay and laser
in situ keratomileusis to compensate for presbyopia in hyperopic
patients: one-year safety and efficacy. J Cataract Refract Surg.
2013;39(11):1713-1721. doi:10.1016/j.jcrs.2013.05.038.
12. Tomita M, Kanamori T, Waring GO, et al. Simultaneous corneal
inlay implantation and laser in situ keratomileusis for presbyopia
in patients with hyperopia, myopia, or emmetropia: six-month
results. J Cataract Refract Surg. 2012;38(3):495-506. doi:10.1016/j.
jcrs.2011.10.03.
13. Garza EB, Chayet A. Safety and efficacy of a hydrogel inlay with
laser in situ keratomileusis to improve vision in myopic presbyopic
patients: one-year results. J Cataract Refract Surg. 2015;41(2):306-
312. doi:10.1016/j.jcrs.2014.05.046.
14. Parkhurst GD, Garza EB, Medina AA Jr. Femtosecond laser-assisted
cataract surgery after implantation of a transparent near vision
corneal inlay. J Refract Surg. 2015;31(3):206-208. doi:10.3928/10815
97X-20150224-05.
15. Gutierrez Amoros C. Surgical correction of presbyopic ametropia
with non-refractive transparent corneal inlay and an implantable
collamer lens. J Refract Surg. 2016;32(12):852-854. doi:10.3928/108
1597X-20161019-01.
16. Jacob S, Kumar DA, Agarwal A, Agarwal A, Aravind R, Saijimol
AI. Preliminary evidence of successful near vision enhancement
with a new technique: PrEsbyopic allogenic refractive lenticule
(PEARL) corneal inlay using a SMILE lenticule. J Refract Surg.
2017;33(4):224-229.
17. Mulet ME, Alio JL, Knorz MC. Hydrogel intracorneal inlays for the
correction of hyperopia: outcomes and complications after 5 years
of follow-up. Ophthalmology. 2009;116(8):1455-1460, 1460.e1.
18. Alio JL, Mulet ME, Zapata LF, Vidal MT, De Rojas V, Javaloy J.
Intracorneal inlay complicated by intrastromal epithelial opacifica-
tion. Arch Ophthalmol. 2004;122(10):1441-1446.
19. Ismail MM. Correction of hyperopia by intracorneal lenses: two-
year follow-up. J Cataract Refract Surg. 2006;32(10):1657-1660.
20. Lindsey SS, McCulley JP, Cavanagh HD, Verity SM, Bowman RW,
Petroll WM. Prospective evaluation of PermaVision intracor-
neal implants using in vivo confocal microscopy. J Refract Surg.
2007;23(4):410-413.
21. Mita M, Kanamori T, Tomita M. Corneal heat scar caused by pho-
todynamic therapy performed through an implanted corneal inlay.
J Cataract Refract Surg. 2013;39(11):1768-1773.
22. Riau AK, Angunawela RI, Chaurasia SS, et al. Reversible femtosec-
ond laser-assisted myopia correction: a non-human primate study
of lenticule reimplantation after refractive lenticule extraction.
PLoS One. 2013;24;8(6):e67058.
23. Pradhan KR, Reinstein DZ, Carp GI, Archer TJ, Gobbe M, Gurung
R. Femtosecond laser-assisted keyhole endokeratophakia: correc-
tion of hyperopia by implantation of an allogeneic lenticule obtained
by SMILE from a myopic donor. J Refract Surg. 2013;29(11):777-782.
24. Sun L, Yao P, Li M, Shen Y, Zhao J, Zhou X. The safety and predict-
ability of implanting autologous lenticule obtained by SMILE for
hyperopia. J Refract Surg. 2015;31(6):374-379.
25. Ganesh S, Brar S, Rao PA. Cryopreservation of extracted corneal
lenticules after small incision lenticule extraction for potential use
in human subjects. Cornea. 2014;33(12):1355-1362.
26. Ganesh S, Brar S. Femtosecond intrastromal lenticular implanta-
tion combined with accelerated collagen cross-linking for the
treatment of keratoconus—initial clinical result in 6 eyes. Cornea.
2015;34(10):1331-1339.
27. Lim CHL, Riau AK, Lwin NC, Chaurasia SS, Tan DT, Mehta JS.
LASIK following small incision lenticule extraction (SMILE) lenti-
cule re-implantation: a feasibility study of a novel method for treat-
ment of presbyopia. PLoS One. 2013;11;8(12):e83046.

Refractive Inlays
David I. Geffen, OD, FAAO
The latest surgical option for presbyopia, corneal inlay
implantation, has been available since 2015 in the United
States.1 Corneal inlays have several advantages over other
refractive procedures. The inlays are an additive technology
that can be removed in the event of patient dissatisfaction,
a complication, or onset of other conditions. These pro-
cedures do not remove any tissue, so patients potentially
can be candidates for future surgical solutions. Compared
to lens surgery, the insertion procedure is less invasive.
Depending on the inlay, near correction often remains
effective as presbyopia advances.
The 3 styles of corneal inlays, all designed for mon-
ocular implantation in the nondominant eye, are cor-
neal reshaping inlays, refractive inlays, and small-aperture
inlays. Refractive inlays incorporate power into the inlay,
and include the Flexivue Microlens (Presbia) and the
Icolens (Neoptics AG). The other inlays are reviewed else-
where in this text.
FLEXIVUE MICROLENS
Currently in phase III Food and Drug Administration
trials in the United States, this hydrophilic acrylic, variable-
power inlay has a 3.2-mm diameter, with a 0.015-mm/15-μm
edge thickness. The inlay’s central 0.15-mm opening allows
for nutrient flow (Figure 6-1).
- 53 -
6
This inlay has a plano central zone for distance vision
and a peripheral zone with increasing rings of higher power
for reading vision. Functioning like a multifocal contact
lens, the inlay comes in a range of powers. It is inserted
under a flap or in a pocket in the nondominant eye, and the
surgeon can remove the lens and replace it with a higher
power inlay as the patient becomes more presbyopic. The
inlay is offered in powers ranging from +1.5 to +3.5 diopters
(D), in 0.25-D increments.
A side pocket is created using a femtosecond laser at
a depth of 250 μm (Figure 6-2). The inlay is placed using a
proprietary inserter (Figure 6-3). Once inserted, the inlay is
nearly invisible (Figure 6-4).
Study results found that 12 months after implantation,
uncorrected near visual acuity (UNVA) reportedly was
20/32 or better in 75% of operated eyes, whereas the mean
uncorrected distance visual acuity (UDVA) of operated eyes
decreased from 0.06 ± 0.09 logMAR (20/20), a statistically
significant difference.2 Overall, higher order aberrations
increased, and contrast sensitivity decreased in the operat-
ed eye. No tissue alterations were found on corneal confocal
microscopy, and no intra- or postoperative complications
occurred.2 Researchers concluded that the inlay appeared
to be an effective method to address the corneal compensa-
tion of presbyopia in emmetropic presbyopes between the
ages of 45 and 60 years.2
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 53-58).
© 2019 SLACK Incorporated.
54  Chapter 6

Figure 6-1. (A) Diagram of the cross section of the Flexivue Microlens inlay. (B) Diagram of the front view Flexivue Microlens inlay.
(C) Flexivue Microlens inlay. (Reprinted with permission from Presbia.)
 Refractive Inlays   55

Figure 6-2. The Flexivue Microlens inlay is placed in a pocket created

in the stroma using a femtosecond laser at the depth of 250 μm.
(Reprinted with permission from Dr. Pavel Stodůlka.)

A B

Figure 6-3. (A) Inlay placement is performed with the aid of a proprietary insertion tool. (B) The pocket self seals and
holds the lens in place at the center of the patient’s visual axis. (Reprinted with permission from Dr. Pavel Stodůlka.)

Figure 6-4. The Flexivue Microlens inlay implanted.

(Reprinted with permission from Presbia.)
56  Chapter 6
Another study of 81 eyes found the mean UDVA in
treated eyes was 0.16 ± 0.08 logMAR after 36 months, which
is better than reported monovision outcomes.3 Binocular
UDVA of 0.10 logMAR was achieved at 12 months, showing
that stereoacuity was maintained after implantation. There
was a loss of more than 1 line of UDVA in the treated eye in
62% of the eyes. The study determined no loss of contrast
between the treated and untreated eyes.3
Stojanovic et al4 investigated the best technique for
combining cataract surgery with Flexivue implantation
using different combinations of surgical steps: intrastromal
pocket creation, inlay implantation, and cataract surgery.
Fifteen patients with bilateral cataracts were treated. In
Group A (3-step group), the intracorneal pocket was cre-
ated in the nondominant eye, bilateral cataract surgery
was performed 3 months later, and the intracorneal inlay
was implanted 6 months after pocket creation. In Group B,
bilateral cataract surgery was performed 3 days after pocket
creation and inlay implantation in the nondominant eye.
In Group C, the pocket creation and the inlay implantation
were performed in the nondominant eye 3 months after
bilateral cataract surgery.4
Twelve months after the inlay implantation, mean
monocular UDVA was 20/32 in the 3-step Group A, 20/32
in Group B, and 20/25 in Group C. Achieved mean mon-
ocular UNVA was similar in the 3 groups (20/25). No
intra- or postoperative complications were observed, and
they reported high patient satisfaction and a high spectacle
independence rate after cataract surgery.
Beer et al5 reported 1-year clinical outcomes follow-
ing implantation of the inlay. The Flexivue Microlens inlay
was implanted in the nondominant eye of patients with a
preoperative refraction of -0.5 D to 1.0 D following creation
of a 300-μm deep stromal femtosecond pocket. One-year
results were reported on 31 patients of mean age 50.7 years.
The mean UNVA improved to J1 (Jaeger) in 87.1% of treated
eyes and all eyes improved 4 lines. The binocular UDVA
was 20/20 in all patients. Ninety percent of the patients
reported that their near vision was good or excellent.
However, 16.1% lost more than 3 lines of corrected distance
visual acuity (CDVA). Anterior segment analysis revealed
induction of negative corneal spherical aberration.
Malandrini et al3 reported results of Flexivue Microlens
inlay implantation in nondominant eyes using a femtosec-
ond laser. They evaluated a total of 81 eyes. In 26 eyes,
the mean preoperative UNVA of 0.76 logMAR improved
to 0.10 logMAR 36 months postoperatively. In this same
group, the UDVA improved from 0.0 logMAR preopera-
tively to 0.15 logMAR 36 months postoperatively. However,
16 (62%) of 26 treated eyes lost more than 1 line of UDVA,
5 eyes (19%) lost more than 2 lines of UDVA, and 2 eyes
(8%) lost more than 1 line of CDVA at 36 months. The
mean binocular UDVA was 0.00 logMAR preoperatively
and not significantly different at 36 months postoperatively.
The mean spherical aberration increased after surgery and
explantation was performed in 6 eyes due to complaints of
glare, halos, and reduced UDVA.3
Malandrini et al6 also evaluated the biocompatibility
of the Flexivue Microlens inlay based on healing of corneal
wounds and analysis of corneal structural features using
in vivo confocal microscopy and anterior segment opti-
cal coherence tomography at 1, 6, and 12 months. In
vivo confocal microscopy showed intense cellular activity
around the inlay in the stroma, including edema, inflam-
mation, and a degenerative material deposition in the first
12 months. At 1 month, hyperreflective areas beneath the
inlay and microfolds were observed in 40% of eyes. The
interface reflectivity decreased over time. Six patients had
inlay removal postoperatively: 3 prior to 6 months, 3 prior
to 12 months. Evaluation of these patients after removal
showed clear corneas without signs of irregularity.
ICOLENS
The Icolens inlay is in the earlier stages of development.
This inlay is similar to the Flexivue Microlens inlay but
incorporates a central power. The inlay is of hydrophilic
copolymer, with a 3.0-mm diameter and an edge thickness
of less than 15 μm (depending on refraction). For presby-
opia, the inlay offers powers ranging from +1.5 D to +3.0 D
(in 0.5-D steps). With no power in the center and positive
refractive power in the periphery, this inlay’s powers can be
exchanged as presbyopia progresses. The device is inserted
using a preloaded delivery system. The company has been
purchased by Presbia, and the future of this device will
most likely be merged with the Flexivue Microlens inlay.
Baily et al7 reported results of the Icolens inlay 12 months
after implantation in the nondominant eye of 52 emme-
tropic patients. Mean UNVA in the surgical eye improved
from N18/N24 (20/200) preoperatively to N8 (20/50) post-
operatively (P < .001). Nine (17%) enjoyed a UNVA of N5
(20/30) or better. Binocularly, there was a mean gain of
0.48 lines of UDVA postoperatively, with 22 patients (42%)
gaining more than 1 line. The UDVA in the surgical eye
improved from 0.05 logMAR preoperatively to 0.22 logMAR
postoperatively, which was statistically significant.
There was a mean loss of 1.67 lines of UDVA (P < .001).
The mean loss of CDVA postoperatively was 1.78 ± 1.04
lines (P < .001). No significant change in corneal topogra-
phy or endothelial cell count was found. Ninety percent of
patients reported being happy (“yes” or “rather yes”) with
their outcome. However, 11 inlays were explanted due to
minimal improvement in UNVA. No significant adverse
events were reported during the study.7
 Refractive Inlays   57

Figure 6-5. Long-term result of Flexivue Microlens implantation.

(Reprinted with permission from Presbia.)

Figure 6-6. Twelve-month satisfaction data. (Reprinted with permission from Presbia.)

be completely stable. At 12 to 24 months, assess biological

POSTOPERATIVE CARE
Follow-up care should be similar for all corneal
inlays.8,9 Patients should be seen at 1 day, 1 week, 1 month,
6 months, and 1 year. Outcomes will vary by patient, but
vision still may be blurry due to edema at the day one visit.
Vision should be expected to stabilize at 1 to 3 months,
pending control of ocular surface disease. Patients should
be monitored for haze development, and treated aggressive-
ly should it occur. Closely monitor for dry eye symptoms
because inlays perform best with a healthy tear film. By
6 months, refractions and corneal topographic maps should
compatibility, as some patients will develop an inflamma-
tory reaction and may require steroids; in some patients,
the inflammation may persist and require additional medi-
cations (Figure 6-5). Figure 6-6 shows the study data at 12
months for the Flexivue Microlens.
While research is revealing many positive visual out-
comes associated with corneal inlays, it is important for
eye care professionals to be aware of the possible risks and
warnings associated with these new procedures. Precautions
include new or worsening problems with glare, halos,
blurred or double vision, fluctuation of vision, dryness, for-
eign body sensation, and pain.8
58  Chapter 6
There may be decreased contrast sensitivity. Corneal
complications such as infection, inflammation, a new dry
eye condition, or worsening of an existing condition may
occur. If steroid eye drop usage to suppress inflammation
from the procedure is required, there is a risk of glaucoma.
Cataract symptoms may worsen or occur sooner. There is a
chance of decreased distance vision in the implanted eye, as
well as the need for additional surgery to remove the inlay
or to exchange it for a new one. There is also a risk for loss
of best-corrected distance vision with eyeglasses or contact
lenses. In rare cases, removal of the inlay will not restore
preoperative vision.
As with most of the presbyopic treatment options,
patient selection is paramount to successful treatment
using corneal inlays.
REFERENCES
1. FDA approves first-of-its-kind corneal implant to improve near
vision in certain patients. https://www.meddeviceonline.com/doc/
fda-approves-first-of-its-kind-corneal-implant-to-improve-near-
vision-in-certain-patients-0001. Published April 17, 2015. Accessed
June 27, 2018.
2. Limnopoulou AN, Bouzoukis DI, Kymionis GD, et al. Visual out-
comes and safety of a refractive corneal inlay for presbyopia using
femtosecond laser. J Refract Surg. 2013;29(1):12-18.
3. Malandrini A, Martone G, Menabuoni L, et al. Bifocal refractive
corneal inlay implantation to improve near vision in emmetropic
presbyopic patients. J Cataract Refract Surg. 2015;41(9):1962-1972.
4. Stojanovic NR, Feingold V, Pallikaris IG. Combined cataract and
refractive corneal inlay implantation surgery: comparison of three
techniques. J Refract Surg. 2016;32(5):318-325. doi:10.3928/108159
7X-20160225-02.
5. Beer SMC, Santos R, Nakano EM, et al. One-year clinical outcomes
of a corneal inlay for presbyopia. Cornea. 2017;36(7):816-820.
6. Malandrini A, Martone G, Canovetti A, et al. Morphologic study
of the cornea by in vivo confocal microscopy and optical coher-
ence tomography after bifocal refractive corneal inlay implanta-
tion. J Cataract Refract Surg. 2014;40(4):545-557. doi:10.1016/j.
jcrs.2013.08.057.
7. Baily C, Kohnen T, O’Keefe M. Preloaded refractive-addition cor-
neal inlay to compensate for presbyopia implanted using a femto-
second laser: one-year visual outcomes and safety. J Cataract Refract
Surg. 2014;40(8):1341-1348. doi:10.1016/j.jcrs.2013.11.047.
8. ReVision Optics. Raindrop Near Vision Inlay patient information
brochure. US Food & Drug Administration. https://www.accessdata.
fda.gov/cdrh_docs/pdf15/P150034d.pdf. Published July 8, 2016.
Accessed June 1, 2018.
9. Dalton M. Correcting presbyopia: monovision or corneal inlays?
EyeWorld20. https://www.eyeworld.org/article-correcting-pres-
byopia--monovision-or-corneal-inlays-. Published March 2015.
Accessed June 1, 2018.

Complex Cases
Using Corneal Inlays
Jessica Heckman, OD and Y. Ralph Chu, MD
Corneal inlay technology has expanded the realm of
surgical near vision correction. New technology comes with
new challenges in both the pre- and postoperative care of
patients considering these technologies. This chapter will
utilize case examples to detail management techniques for
surgical selection and planning as well as postoperative
management, including inlay implantation in patients with
previous refractive surgery, combination laser vision cor-
rection with inlay implantation, implantation post–cataract
surgery, managing corneal haze, and inlay removal.
INLAY IMPLANTATION IN A
REFRACTIVE SURGERY PATIENT
A patient with previous refractive surgery can be
considered for an off-label use of corneal inlay technol-
ogy. Special consideration must be made to locate a previ-
ous LASIK flap. Which inlay and implantation technique
depends on the age and depth of the old LASIK flap. A
KAMRA inlay (CorneaGen) is often the preferred inlay for
a cornea with previous LASIK as it is effective and preferred
to be implanted deeper in the cornea than the Raindrop
inlay (ReVision Optics). The recommended pocket depth
for a KAMRA inlay in post-LASIK patients is 200 μm to
250 μm with a minimum of 80 μm below the flap interface,1
- 59 -
7
while still maintaining a safe distance above the corneal
endothelium of at least 200 μm. Conversely, if a flap is thick
and the surgeon feels comfortable lifting, a Raindrop
inlay could also be implanted for this patient population.
Raindrop inlays have been implanted under flaps as thin as
130 μm.2,3 However, flap thickness of up to 34% has been
shown to have less incidence of haze compared to more
superficial flaps.4
Case 1: KAMRA Inlay Implantation in a
Previous LASIK Patient
A 54-year-old female had myopic LASIK in July 2005
and was looking to decrease her dependence on reading
glasses. Her uncorrected distance visual acuity (UDVA)
was 20/20 OD, OS, and OU. The manifest refraction in her
right eye was 0.00 +0.25 x 107, OS -0.25 +0.25 x 058. Her
uncorrected near visual acuity (UNVA) was J6 (Jaeger)
OD, OS, and OU. The patient had normal ocular health
on slit lamp and fundus examination. The previous LASIK
flap was measured on anterior segment optical coherence
tomography (OCT) to be 141 μm thick, with a total corneal
thickness of 495 μm. (Figure 7-1 shows the OCT image.)
The patient had significant improvement in vision with a
pinhole occluder over her nondominant left eye and elected
to proceed with KAMRA implantation.
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 59-73).
© 2019 SLACK Incorporated.
60  Chapter 7

Figure 7-1. Anterior segment OCT image of measurement of LASIK flap from 2005.

Figure 7-2. KAMRA inlay 1 week postoperative implantation in a femtosecond pocket underneath a
previous LASIK flap.

The KAMRA inlay was implanted in a femtosecond
pocket successfully underneath the LASIK flap at a depth
of 250 μm in the patient’s left eye. At this depth, the LASIK
flap interface was estimated to be 109 μm above the pocket
with 245-μm residual corneal bed. One week status post
KAMRA inlay implantation, the surgical eye had a UDVA
of 20/25- and J1 near vision with manifest refraction of
-1.00 sph. Figure 7-2 shows a picture of KAMRA inlay at 1
week following surgical implantation.
This case example provides a couple of key clinical
pearls for the clinician. OCT works very well to locate and
accurately measure a previous LASIK flap. In addition,
OCT measures total corneal thickness, which is necessary
to plan an inlay procedure that is at the recommended
distance below the LASIK flap, as well as an appropriate
depth for the inlay technology with enough residual tissue
bed left in the cornea. The process for achieving optimal
vision for a corneal inlay is slower than LASIK. Healing
time for corneal inlay technology can often be one of the
most important things to emphasize in a previous LASIK
patient. The patient’s previous point of reference for ocular
surgery healing was much quicker with LASIK, than what
will likely be experienced with an inlay.

Figure 7-3. Right eye Pentacam prior to refractive surgery.
REFRACTIVE ERROR
AND CORNEAL INLAYS
As an off-label use of corneal inlays, both the KAMRA
and Raindrop inlays can be implanted concurrently or
consecutively with laser vision correction in patients with
either hyperopic or myopic preoperative refractions.2,3,5,6
The ability to combine surgical technology allows the
surgeon to optimize a patient’s refraction for inlay implan-
tation to ultimately result in the best outcomes. A mildly
myopic refraction of -0.75 diopters (D) remains the widely
accepted ideal refraction for a KAMRA inlay.7 Conversely,
plano to +0.5 D is the generally preferred preoperative
refraction for Raindrop implantation.8
As was discussed previously, the KAMRA inlay is
placed in a femtosecond pocket that is a minimum of 80 μm
below the patient’s LASIK interface whether done on the
same or different days.1 Photorefractive keratectomy is also
able to be combined with a KAMRA inlay in combination
or consecutively. Although photorefractive keratectomy has
a longer healing course than LASIK, it eliminates the risk
of LASIK flap complications and the risk of flap interface
disruption and minimizes postoperative dryness.
Raindrop inlays are often done in combination with
LASIK surgery as well. The LASIK flap needs to be adjusted
in the inlay eye to the increased thickness required for
Raindrop inlay implantation, up to 34% of corneal thick-
ness.4 When using inlays off-label in combination with
laser vision correction, the clinician must also take care to
implant the inlay at recommended depth above the corneal
endothelium.
Complex Cases Using Corneal Inlays   61
Case 2: Combination Laser Vision
Correction With KAMRA
A 52-year-old male presented to our clinic seeking less
dependence on reading glasses. His UDVA was 20/20 in
each eye with manifest and cycloplegic refraction of +0.50
+0.25 x 063 in his right eye and +0.50 +0.25 x 050 in his
left eye. The patient’s UNVA was J10 in his right eye and
J8 in his left. Anterior and posterior segment health were
normal on examination. The patient had normal topog-
raphy and his central corneal thickness was 513 μm in
his right eye and 517 μm in his left. Figure 7-3 shows the
patient’s Pentacam (Oculus) map prior to refractive sur-
gery. The patient’s dominant eye was his left eye. A pinhole
occluder was used to simulate vision with a KAMRA inlay.
The patient noticed significant improvement in vision at
both distance and near vision with the pinhole occluder
in combination with a +1.25 loose lens over his right eye.
The patient elected to proceed with KAMRA inlay with
advanced surface ablation prior to the procedure to target
for a -0.75 manifest refraction to optimize patient result.
The patient underwent uncomplicated advanced sur-
face ablation in his right eye to result in the specified
myopic target to optimize inlay outcome. The patient
then proceeded with a KAMRA inlay 2 months later. The
patient’s Pentacam following advanced surface ablation is
shown in Figure 7-4. The KAMRA inlay was implanted
in a femtosecond pocket at a depth of 250 μm. The next
day the patient returned with UDVA OD 20/30, OU 20/20
and UNVA OD J1, OU J1. At 1 week postoperatively, the
patient’s UDVA improved to 20/20 in his right eye and his
UNVA improved to J1+ with a manifest refraction of -0.75
+0.25 x 137 in the surgical eye.
62  Chapter 7
Figure 7-4. Right eye Pentacam following anterior surface ablation.
This case demonstrates a patient having a refrac-
tive error that was not ideal for an optimal result with a
KAMRA inlay. The targeting process for the patient began
during his preoperative examination with the addition of
a +0.75 D add over the pinhole occluder to aid the patient
in visualizing the benefit of laser vision correction prior
to KAMRA implantation. Refractive targeting prior to
implantation of the KAMRA inlay allowed the patient to
experience significantly improved vision at an early stage
in the postoperative period.
Case 3: Combination LASIK
With Raindrop
A 50-year-old female presented to our clinic seeking
decreased dependence on both distance and near vision
correction. Her UDVA was 20/40 OD, OS, and OU. Her
UNVA was J10 OD, J8 OS, and J6 OU. She was wearing
“cheaters” for distance vision and stronger cheaters for near
vision. Occasionally, the patient would wear a monovision
contact lens in her right eye, but not full time as she did not
like the degree of blur for distance activities. Her manifest
and cycloplegic refraction were +1.50 +0.75 x 065 OD and
+1.25 +1.00 x 088 OS with 20/20 acuity. Slit lamp and dilated
fundus examination were normal. The patient had normal
topography and her central corneal thickness was 538 OD
and 527 OS. Figure 7-5 shows the preoperative Pentacam
map for the patient’s right eye. The patient elected to pro-
ceed with LASIK in both eyes with Raindrop implantation
in her right eye. The patient underwent successful LASIK
with a plano target for each eye then subsequent Raindrop
inlay implantation in her right eye. The flap thickness of
the right eye was 170 μm, which provided appropriate depth
for Raindrop inlay implantation with adequate residual
corneal bed following LASIK ablation.
The first day postoperatively, the patient’s UDVA was
20/50 OD and 20/20 OS. UNVA was J1 OD, J5 OS, and J1
OU. At 6 months postoperatively, the patient’s UDVA was
20/40 OD, 20/20 OS, 20/20 OU, and manifest refraction
-1.00 +0.35 x 115 OD and -0.25 OS. The patient’s uncor-
rected near vision was J1+ OD, J5 OS, J1+ OU. The patient
denied needing glasses at any distance. Figure 7-6 shows the
patient’s postoperative Pentacam Holladay report. Figure
7-7 shows the Pentacam densitometry, and Figure 7-8 shows
a slit lamp image of the patient’s Raindrop inlay 6 months
postoperatively.
This patient case shows a successful result with a com-
bined surgical procedure on the same day. Because the ideal
refractive error for Raindrop implantation is plano or mild-
ly hyperopic, the patient was targeted for a plano refraction.
The pearl to remember when planning a procedure of this
nature is to adjust the LASIK flap for the increased thick-
ness required to minimize risk of corneal haze while main-
taining appropriate residual corneal bed thickness.
 Complex Cases Using Corneal Inlays   63

Figure 7-5. Preoperative Pentacam OD.

Figure 7-6. Postoperative Pentacam OD.

64  Chapter 7
Figure 7-7. Pentacam densitometry 6 months postoperatively.
Figure 7-8. Slit lamp image of Raindrop inlay at 6 months
postoperatively.
PSEUDOPHAKIC PATIENTS
The pseudophakic population is a vast subset of patients
with a need for reading glasses. Patients with both KAMRA
and Raindrop inlays have undergone successful cataract
surgery.9 Off-label usage of intracorneal inlays following
successful cataract surgery has shown promising visual
results as well. The cataract population, as a function of age,
does tend to have more ocular surface disease, so consider-
ation of implantation and careful counseling in this patient
population regarding risks and benefits as well as aggressive
ocular surface management postoperatively are important
for success in this demographic. A surgeon may consider
implantation in a femtosecond pocket vs underneath a flap
to minimize postoperative dryness.
Case 4: Raindrop Inlay Implantation
Post–Cataract Surgery
A 66-year-old male underwent successful cataract
surgery with a monofocal cataract lens implant in February
2013 in his right eye and in February 2015 in his left eye.
The patient was very happy with his distance vision, but
was desiring decreased dependence on his reading glasses
when he presented to our clinic in 2016. His UDVA was
20/20 OD, OS, and OU. His UNVA was J8 OD, J6 OS,
and J5 OU. His refraction was plano +0.50 x 090 OD and
-0.25 +0.50 x 035 OS with 20/20 best-corrected visual
acuity (BCVA). The patient’s right eye was dominant. His
posterior chamber intraocular lenses were well positioned
with clear, intact capsules. His fundus exam was normal
with the exception of a repaired retinal tear peripherally
in his right eye. Topography was normal. Pachymetry was
measured at 601 OD and 588 OS. The first tear break-up
measured by a Keratograph (Oculus) noninvasive break-up
time (NIKBUT) scan in the surgical eye was 8.41 seconds
and average break-up was 13.57 seconds. The AcuTarget
HD Analyzer (Visiometrics) measured the patient’s ocular
scatter index (OSI) at 1.1. Figure 7-9 shows the Keratograph
NIKBUT measurement on the surgical eye, and Figure 7-10
shows the patient’s preoperative OSI from the AcuTarget
HD Analyzer.
The Raindrop inlay was successfully implanted under-
neath a femtosecond flap made at 180-μm depth in the
patient’s left eye. At the patient’s 1-day postoperative exami-
nation, his UDVA was 20/40 in his left eye and UNVA was
J1 with -0.50 +0.25 x 146 refraction. The patient reported
that he noticed improvement; however, he felt his vision was
 Complex Cases Using Corneal Inlays   65

Figure 7-10. AcuTarget HD Analyzer OSI

measurement.
Figure 7-9. Tear break-up measured by a Keratograph NIKBUT
scan.

still relatively fuzzy. On slit lamp examination, the Raindrop

inlay was centered and clear. The OSI measurement was
performed on the patient using the AcuTarget HD Analyzer.
The OSI measured 7.1 in the patient’s right eye. Figure 7-11
shows the OSI image.
At 1 week postoperatively, the patient’s uncorrected
visual acuity remained the same at both distance and near
with a manifest refraction of -0.50 sph. However, the patient
felt his quality of vision had improved significantly and was
happy. The OSI was again measured and had improved to
2.8. Figure 7-12 shows this OSI measurement.
In our experience, assessment of the ocular surface
quality of a patient preoperatively and then monitoring
an appropriate treatment postoperatively are critical to
obtaining best outcomes with either inlay procedure. A
measurement of tear break-up time, OSI, meibomian gland
function, Inflammadry (Rapid Pathogen Screening, Inc),
and/or tear osmolarity can assist the clinician in determin-
ing a patient’s risk for ocular surface disease and the need
for pre- and/or postoperative treatment. This specific case
highlights the benefit of measurement of OSI to further
quantify a patient’s visual quality. The higher the OSI mea-
Figure 7-11. OSI 1 day post-Raindrop
surement, the more blur a patient tends to experience. As inlay.
ocular surface quality improves with postoperative healing,
or more aggressive ocular surface management, the OSI
trends lower. If a patient is struggling with vision and has a
high OSI, implementation of more aggressive ocular surface
management may be warranted.
66  Chapter 7
Figure 7-12. OSI 1 week post-Raindrop
inlay.
CORNEAL HAZE
Monitoring corneal clarity postoperatively is impor-
tant due to the risk of corneal inflammation and haze that
corneal inlays can induce. In clinical trials the risk of all
corneal haze was 3.4% when the Raindrop was implanted at
a depth of 31% to 34% of the cornea.4 The rate of haze with
KAMRA is similar, with less than 1% of eyes with corneal
haze causing a 2-line loss of best-corrected distance visual
acuity at 12 months in clinical trials.10 If corneal haze is
observed on examination, treatment with topical steroid
and then taper schedule are necessary for resolution.
The clinical signs of corneal haze are different for each
inlay. A hyperopic shift in refraction will often be present
in a patient with a KAMRA inlay that is developing corneal
haze. The patient will subsequently notice diminishing near
acuity. On Placido disc topography, a red ring will present
over the KAMRA inlay. Conversely, a myopic shift will
typically occur when a patient with a Raindrop inlay starts
developing haze. The Raindrop patient will notice a closer
near point working distance and diminished distance acu-
ity. The Pentacam HR (Oculus) densitometry works very
well for diagnosis as well as monitoring treatment and
Figure 7-13. Raindrop corneal inlay with haze.
resolution of corneal haze in Raindrop inlays.11 The next
case examples will demonstrate the presentation and treat-
ment of corneal haze.
Case 5: Corneal Haze Post-Raindrop
A 50-year-old man with a Raindrop inlay returned
for a routine postoperative exam at 7 months following his
procedure. At this examination, the patient reported that
he was having more difficulty with computer vision and
having to hold near work closer to see. The patient was
using Restasis (cyclosporine) and artificial tears twice daily.
The patient’s UDVA in the surgical eye was 20/50 and his
UNVA was 20/20. The patient’s vision improved to 20/20
with a -1.00 refraction. On slit lamp examination 1+ corneal
haze was noted. The patient was started on a month-long
taper of difluprednate, 1 drop 4 times daily for 1 week then
decreasing by 1 drop each subsequent week. After the dif-
luprednate taper was completed, the patient was started on
treatment with loteprednol 0.5% twice daily for 1 month.
Figure 7-13 shows the slit lamp image, and Figure 7-14
shows the Pentacam densitometry of the Raindrop inlay
with corneal haze.
The patient reported significant improvement in vision
2 months later. The patient reported his working distance
had improved and was happier with his vision. His UDVA
measured 20/20 and UNVA measured 20/25-. His manifest
refraction measured -0.25 D sph with BCVA of 20/20. The
patient was instructed to continue Restasis twice daily and
decrease loteprednol 0.5% to once daily for 1 month then
discontinue. Figure 7-15 shows the Pentacam densitometry
of the Raindrop inlay following haze resolution.
 Complex Cases Using Corneal Inlays   67

Figure 7-14. Pentacam densitometry of Raindrop inlay with corneal haze.

Figure 7-15. Pentacam densitometry following haze resolution.

Case 6: Corneal Haze Post-KAMRA
Corneal haze can be very subtle to detect. In our expe-
rience, the earlier treatment is initiated, the less likelihood
a patient has of developing chronic haze. A patient who
had a KAMRA inlay implanted returned to our clinic for
her 6 month postoperative follow-up. She reported that her
vision had gotten worse over the past 3 weeks for reading.
She denied fluctuating vision, just noticed that consistently
she was having to wear readers to improve her vision, where
she had not previously. The patient was using lifitegrast
once daily and artificial tears twice daily on average. Her
UDVA in her inlay eye was 20/30 and her UNVA was J1-.
Her manifest refraction was +0.50 D sph and best corrected
to 20/20. The inlay was centered and very mild corneal haze
was observed on slit lamp examination. The patient’s ocular
surface looked clear. Her previous examination had been
done 3 months prior. Her uncorrected distance and near
vision was identical, however, her refraction was -1.0 D sph
at that time.
Although the patient’s vision measured similar to her
last exam, the patient was started on topical steroid treat-
ment secondary to the hyperopic shift and subtle haze
appearance on slit lamp examination. The patient was start-
ed on a month-long loteprednol 0.5% taper. She returned 1
month later for a follow-up and reported her vision had
improved to normal and no longer needed to wear read-
ing glasses. Her manifest refraction was -0.25 D sph
with UDVA 20/20 and UNVA J1 in her surgical eye. This
patient displayed the classic hyperopic shift typically seen
68  Chapter 7
Figure 7-16. Pentacam densitometry at 6-month postoperative examination.
with mild KAMRA inlay haze and resolved nicely with a
steroid taper. The patient’s OSI as measured on Acutarget
improved from 1.9 to 1.0. The patient was continued on
loteprednol 0.5% once daily and lifitegrast twice daily for
the next 3 months.
These 2 case examples show the typical presentation of
corneal haze following implantation with both Raindrop
and KAMRA inlays and good resolution of the haze follow-
ing treatment with steroids.
CORNEAL INLAY EXPLANTATION
The removability of corneal inlays is an attractive
feature of the technology for both patients and surgeons.
Although explantation rate is low, the 2 most common rea-
sons for corneal inlay removal are patient dissatisfaction and
persistent corneal haze.4,12,13 Studies have shown patients
return to within 0.75 D to 1.0 D of their preoperative mani-
fest refraction spherical equivalent following intracorneal
inlay explantation and typically achieve 20/25 corrected dis-
tance visual acuity or better.4,12,13 Visual recovery can take
6 months or longer following inlay removal.4,12,13
Case 7: Raindrop Corneal
Inlay Explant
A healthy 47-year-old male was successfully implanted
with a Raindrop corneal inlay in his left eye. The patient’s
vision at 3 months postoperatively was 20/20 distance
OS and 20/20 near OS with a manifest refraction OS of
-0.25 D sph. The inlay was clear and centered and patient
was happy with his level of functional vision.
The patient returned for his 6-month postoperative
examination. The patient reported that his near point of
focus had moved closer over the past 2 weeks. The patient’s
UDVA in his left eye was 20/40 and UNVA was 20/20.
The manifest refraction of -1.5 D sph improved vision to
20/25 in the surgical eye. Mild haze was noted on slit lamp
examination, and the patient was started on a month-long
difluprednate taper. Figure 7-16 shows the Pentacam densi-
tometry of the patient’s Raindrop inlay.
The patient returned 1 month later for a follow-up
examination. He reported his vision improved significantly
after 1 week of difluprednate treatment and was doing bet-
ter at both distance and near. The patient’s uncorrected
distance visual acuity in his left eye was 20/30 and near was
20/20. The patient’s refraction returned to -0.25 with 20/20
BCVA. On slit lamp examination, the inlay was clear cen-
trally with stable, expected peripheral edge haze.
The patient was diagnosed with a recurrence of cor-
neal haze at 9 months and 18 months post-Raindrop inlay
implantation. Both episodes of haze were resolved with a
topical steroid taper. Figure 7-17 shows the Pentacam and
Figure 7-18A for slit lamp photos of the patient’s inlay at 18
months postoperative. Upon haze resolution, the patient was
maintained on cyclosporine 0.05% twice daily in the surgical
eye. The patient was seen at 6-month intervals over the next
1.5 years. His cornea remained clear during this time, and he
was very happy with his level of vision at all distances.
 Complex Cases Using Corneal Inlays   69

Figure 7-17. Pentacam densitometry at 18 months post-Raindrop inlay implantation.

A B

Figure 7-18. (A) Raindrop inlay with central haze 18 months after implantation. (B) Raindrop inlay with central haze 36 months following
implantation.

At 36 months postoperatively, the patient was again
diagnosed with central haze on his Raindrop corneal inlay.
The patient reported his vision seemed more “washed out.”
He had stopped Restasis and was using artificial tears
minimally. The patient’s UDVA OS was 20/40 and UNVA
was J1. Figures 7-18B and 7-19 show the slit lamp image and
Pentacam. Again, the patient was started on difluprednate
for 1 month followed by a long loteprednol taper.
Over the next 6 months, the patient would show
improvement in corneal haze with topical steroid treatment,
but would recur quickly after taper or discontinuation even
with consistent Restasis use. Unfortunately, the patient
began to develop steroid response intraocular pressure
elevation. The patient was happy with his vision and was
resistant to explantation due to his good near vision. Due
to the inability to maintain a clear inlay off the steroid,
and becoming less able to use topical steroids secondary
to intraocular pressure elevation, the decision was made to
explant the Raindrop inlay. Figure 7-20 shows the slit lamp
image of the Raindrop inlay with significant corneal haze
prior to explantation. Figure 7-21 shows the Pentacam den-
sitometry prior to explant.
70  Chapter 7

Figure 7-19. Pentacam densitometry of Raindrop inlay with central haze 36 months following implantation.

Figure 7-20. Slit lamp image of the Raindrop inlay prior to

explanation.

Figure 7-21. Pentacam densitometry of Raindrop inlay prior to explanation.


Figure 7-22. Pentacam 1 month status post explant.
Figure 7-23. Pentacam 3 months status post explant.
The Raindrop inlay was explanted without complica-
tion. The patient was treated medically with a month-long
difluprednate taper (4 times a day for 1 week, 3 times a day
for 1 week, 2 times a day for 1 week, 1 time a day for 1 week).
Cyclosporine 0.05% was continued for 6 months following
explantation. At 1 month postoperatively, the UDVA in the
left eye was 20/20; however, the patient did report subjective
haze to his distance vision. The corneal clarity improved
over the first 12 months following explantation as did
the patient’s subjective symptoms. At the patient’s recent
Complex Cases Using Corneal Inlays   71
examination at 2 years after inlay explantation, the clarity
of the cornea had improved further. Figures 7-22 through
7-26 show serial Pentacam densitometry data showing the
resolution of corneal haze following this patient’s explant.
The resolution in corneal haze corresponded with the
patient’s subjective improvement in vision throughout the
course of healing. Two years following Raindrop explanta-
tion, the patient has UDVA 20/25 with BCVA 20/20 with
+0.75 refraction OS. The cornea is clear and the patient is
happy with distance vision and uses readers full time.
72  Chapter 7

Figure 7-24. Pentacam 6 months status post explant.

Figure 7-25. Pentacam 12 months status post explant.


Figure 7-26. Pentacam 2 years status post explant.
CONCLUSION
Intracorneal inlays have significantly changed the
treatment of presbyopia. Proper patient selection, optimiz-
ing patient preoperative refraction, and maximizing ocular
surface will aid the clinician in obtaining optimal outcomes
with this technology. Understanding signs and symptoms
of corneal haze and ocular surface dryness will assist the
clinician in the long-term management of these patients.
REFERENCES
1. Tomita M, Kanamori T, Waring GO 4th, Nakamura T, Yukawa
S. Small-aperture corneal inlay implantation to treat presby-
opia after laser in situ keratomileusis. J Cataract Refract Surg.
2013;39(6):898-905.
2. Garza EB, Chayet A. Safety and efficacy of a hydrogel inlay
with laser in situ keratomileusis to improve vision in myopic
presbyopic patients: one-year results. J Cataract Refract Surg.
2015;41(2):306-312.
3. Chayet A, Barragán Garza E. Combined hydrogel inlay and laser
in situ keratomileusis to compensate for presbyopia in hyperopic
patients: one-year safety and efficacy. J Cataract Refract Surg.
2013;39(11):1713-1721.
4. Whitman J, Daugherty PJ, Parkhurst GD, et al. Treatment of presby-
opia in emmetropes using a shape-changing corneal inlay: one-year
clinical outcomes. Ophthalmology. 2016;123(3):466-475.
Complex Cases Using Corneal Inlays   73
5. Tomita M, Waring GO 4th. One-year results of simultaneous laser
in situ keratomileusis and small-aperture corneal inlay implanta-
tion for hyperopic presbyopia: comparison by age. J Cataract Refract
Surg. 2015;41(1):152-161.
6. Tomita M, Kanamori T, Waring GO 4th, et al. Simultaneous corneal
inlay implantation and laser in situ keratomileusis for presbyopia in
patients with hyperopia, myopia, or emmetropia: six-month results.
J Cataract Refract Surg. 2012;38(3):495-506.
7. Fernández EJ, Schwarz C, Prieto PM, Manzanera S, Artal P.
Impact on stereo-acuity of two presbyopia correction approach-
es: monovision and small aperture inlay. Biomed Opt Express.
2013;4(6):822-830.
8. Steinert RF, Schwiegerling J, Lang A, et al. Range of refractive
independence and mechanism of action of a corneal shape-chang-
ing hydrogel inlay: results and theory. J Cataract Refract Surg.
2015;41(8):1568-1579.
9. Tan TE, Mehta JS. Cataract surgery following KAMRA presbyopic
implant. Clin Ophthalmol. 2013;7:1899-1903.
10. Binder P; AcuFocus, Inc. Safety and effectiveness of the AcuFocus
corneal inlay ACI7000PDT in presbyopes. US National Library
of Medicine: ClinicalTrials.gov. http://clinicaltrials.gov/show/
NCT01352442. Punlished May 11, 2011. Updated March 28, 2017.
Accessed June 1, 2018.
11. Chu YR, Heckman JH, Lee BR. Diagnostic and management tool for
monitoring patients implanted with a shape-changing corneal inlay.
Submitted for publication to J Refract Surg, manuscript number
JCRS-17-573.
12. Alió JL, Abbouda A, Haseynli S, Knorz MC, Mulet Homs ME,
Durrie DS. Removability of a small aperture intracorneal inlay for
presbyopia correction. J Refract Surg. 2013;29(8):550-556.
13. Yilmaz ÖF, AlagÖz N, Pekel G, et al. Intracorneal inlay to cor-
rect presbyopia: long-term results. J Cataract Refract Surg.
2011;37(7):1275-1281.
 SECTION THREE
Lens-Based Treatment
for Presbyopia

Overview of
Refractive Lens Exchange
Kristin Neatrour, MD; Lisa Sitterson, MD; and George Waring IV, MD, FACS
Compared with corneal-based refractive surgery, lens-
based surgery not only offers the advantages of correcting
a patient’s refractive error, but it has the distinct advan-
tages of improving image quality when lens opacity exists,
addressing presbyopia at the source, and obviating the need
for future cataract surgery. Presbyopia is caused by age-
related thickening and stiffening of the crystalline lens with
gradual loss of accommodative function over time. While
corneal refractive surgery can correct a patient’s refrac-
tive error, it does not halt the progression of presbyopia.
As lens changes progress with age, patients will have some
degradation of visual quality and function despite spectacle
independence postoperatively after corneal-based surgery.
This chapter provides an overview of lens-based surgery,
specifically refractive lens exchange (RLE), and describes
the relevant surgical indications, techniques, and diagnos-
tic and intraoperative technology. In RLE, the presbyopic,
or dysfunctional, crystalline lens is removed either manu-
ally or by using femtosecond laser–assisted surgery and
replaced with an intraocular lens (IOL) implant. RLE has
also been referred to in the literature as dysfunctional lens
replacement and clear lens extraction or exchange.
- 77 -
8
DYSFUNCTIONAL LENS SYNDROME
Loss of accommodative function of the crystalline lens
typically occurs in the late 40s and early 50s. Visually and
clinically significant opacification of the lens typically
occurs later in life. By studying the anatomy and biome-
chanics of accommodation, we have a much better under-
standing of the anatomical and physiologic changes that
occur. Ciliary muscle contraction results in anterior and
centripetal displacement of the ciliary body and causes an
increase in optical power of the lens due to curvature and
thickness changes. There are also accommodative changes
in the zonular fiber configuration and support, axial length,
corneal higher order aberrations, scleral contour, choroid,
retina, aqueous, and vitreous. With presbyopia, the lens and
capsule thicken and stiffen, and the anterior curvature steep-
ens. Further age-related changes in the other extralenticular
structures also contribute to reduced accommodation.1
The term dysfunctional lens syndrome (DLS) refers to
a normal aging phenomenon and progressive constellation
of a triad of signs and symptoms. The triad of the dysfunc-
tional lens is:
1. The loss of accommodation from presbyopia
2. Early lens opacities
3. Increased higher order aberrations
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 77-85).
© 2019 SLACK Incorporated.
78  Chapter 8
Diagnostic technology is used to further delineate this
triad to both grade the dysfunction of the lens and educate
patients on their diagnosis and most appropriate treatment
options. This technology is described in detail later in this
chapter.
Three stages of DLS have been described previously by
George Waring IV, MD, and others, with each stage becom-
ing progressively more advanced. In stage 1, there is loss of
accommodation, increased higher order aberrations, with a
relatively clear lens. In stage 2, presbyopia is more advanced
with a further reduction in accommodative amplitude.
Additionally, lens opacification worsens due to increasing
radiation and oxidative burden. This reduces optical clarity
and increases higher order aberrations and light scatter. In
stage 3, the lens opacification progresses to the point of a
visually significant cataract both subjectively and objective-
ly. It is functionally impacting a patient’s ability to perform
his or her activities of daily living, such as driving, working,
and reading. A stage 3 dysfunctional lens meets the criteria
to qualify for insurance-based cataract surgery.
Figure 8-1 depicts the 3 stages of DLS. With RLE,
patients are able to optimize their long-term visual per-
formance well before the onset of a visually and clinically
significant cataract.1
SURGICAL INDICATIONS FOR
REFRACTIVE LENS EXCHANGE
RLE is indicated for patients stages 2 and 3 DLS, or
stage 1 with moderate to high degrees of hyperopia, with
the goal of achieving emmetropia (or near emmetropia
based on the desired target) and reasonable spectacle inde-
pendence. A successful outcome in RLE hinges on careful
consideration of the indications, risk-benefit ratio, and
appropriate patient selection. General indications for RLE
include refractive error, varying degrees of presbyopia,
lens opacification, higher order aberrations, and desire for
spectacle-independence.
For patients with presbyopia, RLE offers the poten-
tial for desirable functional binocular vision at multiple
focal points for improved visual performance at distance,
intermediate, and near. Specific considerations need to be
made based on a patient’s age, refractive error, degree of
presbyopia and lens opacity, corneal topography, goals for
spectacle independence and functionality, ocular history,
dry eye status, and subjective complaints.
Hyperopia and Short Axial Length
Moderate to high degree of hyperopia is an indication
for RLE, especially in patients who have a shallow anterior
chamber that predisposes them to the risk of developing
angle-closure glaucoma. Our group has previously reported
anterior segment parameters of patients with at least
1.5 diopters (D) of hyperopia pre- and postoperatively after
laser–assisted cataract surgery to determine the surgical
effects. In this study, surgery significantly increased the
iridocorneal angle and the anterior chamber volume.2
Myopia
The primary refractive surgery options for myopia
include LASIK, SMILE, photorefractive keratectomy (PRK),
phakic IOL implantation, and RLE. The optimal procedure
depends on age, degree of refractive error, presbyopia sta-
tus, and ocular anatomy. For a younger myope who is a
poor candidate for corneal-based refractive surgery, phakic
IOL implantation may be a better option as it will preserve
accommodation before the progression of presbyopia.
Caution should be exercised with RLE in high myopes.
In the preoperative evaluation of high myopes, a retina
evaluation is recommended. The major complication con-
cern in RLE is the risk of pseudophakic retinal detachments
(RD). Younger age (less than 50 years old), male sex, family
history of RD, personal history of RD, high axial length,
history of ocular trauma, predisposing retinal lesions, and
posterior capsular tear are all associated with a higher risk
of pseudophakic RD. The risk of RD after RLE or cataract
surgery in high myopes varies from 0% to 8% based on mul-
tiple studies. In one study, the incidence of RD (2.7%) was
twice that in unoperated myopic eyes and in nonmyopic
eyes undergoing standard phacoemulsification. The surgi-
cal options should be considered within the context of the
patient’s age, axial length, and vitreoretinal interface status.
According to the American Academy of Ophthalmology’s
preferred practice guidelines, prophylactic laser retino-
pexy is indicated for acute symptomatic horseshoe tears or
dialysis and traumatic holes. Myopic patients who have not
yet developed a posterior vitreous detachment may be at
increased risk for RD.
Astigmatism
In patients with regular astigmatism, the primary
methods of treating astigmatism at the time of RLE include
performing limbal relaxing incisions (LRIs), astigmatic
keratotomy, or implanting a toric IOL. The procedure of
choice depends largely on the magnitude and location of
the steep axis. Technological considerations for astigma-
tism management are discussed later in this chapter.
Irregular Astigmatism
Irregular astigmatism is approached differently and
on a case-by-case basis. In patients with keratoconus,
RLE and implantation of a toric IOL may be appropriate
if the corneal topography displays radial symmetry in the
effective optical zone, which is the central 3.0-mm zone. If
there is radial asymmetry within the effective optical zone,
then we recommend conservative astigmatic treatment
targeting the lowest astigmatism difference between the
 Overview of Refractive Lens Exchange   79

A1 A2

B1 B2

C1 C2

D1 D2

Figure 8-1. Pentacam (Oculus) Scheimpflug images (left) paired with

corresponding HD analyzer images (right) demonstrating the diagnostic
classification of the stages of DLS. (A) For stage 1, a corneal-based
procedure is recommended (except in the case of moderate or high
hyperopia, in which case a lens-based procedure is preferred). (B) For
stage 2 and (C) stages 2 to 3, a lens-based procedure is indicated due to
mild lenticular changes. (D) Stage 3 DLS meets subjective and objective
criteria for insurance-based cataract extraction.
80  Chapter 8
keratometric axes in this zone. With this method, the total
astigmatism may be undertreated, but it will provide the
most optimal optical quality. A toric IOL is not indicated
for patients with keratoconus who plan to continue wearing
rigid gas-permeable contact lenses or who plan to undergo a
corneal transplant or other corneal procedure in the future.
In patients who have undergone corneal crosslinking, the
ongoing keratometric changes are often unpredictable. For
this reason, we recommend caution with performing LRIs
or using toric IOLs to treat the astigmatism in patients who
have undergone corneal crosslinking.
Fuchs’ Dystrophy
During cataract surgery for patients with Fuchs’ dystro-
phy, minimal phaco energy should be used to avoid further
endothelial cell loss. RLE may be of benefit if done earlier
in the disease process before more significant endothelial
loss occurs because when a true cataract develops, higher
amounts of phacoemulsification energy and surgical manip-
ulation will be required. Our group has previously reported
a case series of patients with mild to moderate Fuchs’
dystrophy undergoing femtosecond laser–assisted cataract
surgery (FLACS) that were evaluated pre- and postopera-
tively for changes in corneal thickness and endothelial cell
count. Mean corneal thickness measurements prior to and
after surgery were not statistically different. In the subset of
patients that had endothelial cell counts collected, the mean
cell count preoperative and postoperative was not signifi-
cantly different. Based on this analysis, FLACS may protect
endothelial cell function to a greater extent than traditional
phacoemulsification.3 LASIK is relatively contraindicated in
Fuchs’ patients because the compromised endothelial pump
system may not sufficiently hold the LASIK flap in place.
PREOPERATIVE CONSIDERATIONS
The preoperative evaluation for patients undergo-
ing RLE is similar to that of refractive cataract surgery.
Emphasis is placed on a specific and separate informed
consent process, IOL selection based on the patient’s goals,
determination of ocular dominance, and IOL calculations.
Informed Consent Process
Once it is determined that a patient is an appropriate
candidate for RLE, he or she should be counseled with an
extensive discussion of the risks, benefits, and alternatives.
The risk-benefit ratio is discussed in the context of the
patient’s surgical and nonsurgical options, including glass-
es, contact lenses, and other refractive procedures. Patients
need to understand the risks of intraocular and corneal-
based surgery. This is an ideal time to assess and manage
a patient’s expectations about RLE. Despite the advancing
technology of IOLs, the functionality of the young crystal-
line lens cannot be replicated and the remaining natural
accommodation is lost. The patient’s goals should be care-
fully examined to determine if spectacle independence
outweighs the changes in visual quality that may occur with
certain IOL choices.
The written consent for RLE is distinct from that for
cataract surgery. The procedure should read “removal of
crystalline lens and insertion of IOLs.” A written consent
should be done for the femtosecond laser and any astigma-
tism correcting procedures as well.
Intraocular Lens Selection
IOL selection is based on the patient’s desired postop-
erative refraction and goals, as well as prior ocular surger-
ies. The effectiveness of a blended vision strategy has been
demonstrated and has been used for years. Historically, the
dominant eye is targeted for a plano target and the non-
dominant eye is typically targeted for a -1.5 D target with
monofocal implants. It is advantageous when the candidate
has previously worn contact lenses for blended vision.
Patients who desire binocular vision at various targets
may be better candidates for multifocal, accommodating,
or extended depth of focus IOLs. Preoperative counseling
involves discussion regarding dysphotopsias of the dif-
fractive presbyopia correcting IOLs and possible need for
reading spectacles for reading fine print or other specific
tasks. The indications for different IOLs are discussed later
in this chapter and in more detail in the subsequent chap-
ters. Patient discussion on the basic IOL types and their
indications is important at this stage of the preoperative
clinic visit.
Patients with a history of refractive corneal surgery or
who have a highly aberrated cornea require unique con-
sideration for IOL selection. The spherical aberration of
the IOL is matched or balanced with the induced corneal
spherical aberration from the prior refractive procedure. In
post–myopic LASIK or PRK patients, whose corneas have
positive spherical aberration, IOLs with negative spherical
aberration are indicated as they balance the corneal posi-
tive spherical aberration with the IOL’s negative spherical
aberration. In post–hyperopic LASIK or PRK patients,
whose corneas have negative spherical aberration, IOLs
with aspheric neutrality are preferred. In highly aberrated
corneas, such as those with keratoconus, an aspherically
neutral implant will provide the best refractive results.
Ocular Dominance Determination
Determination of ocular dominance is an important
measurement in refractive lens surgery, particularly when
a mix and match strategy is utilized or when patients opt
for blended vision postoperatively. There are both motor
and optical methods. Motor dominance is easier to deter-
mine and is more commonly used in the clinical setting.
However, optical dominance is more accurate in determin-
ing the true dominant eye.

There are various tests to determine motor dominance.
In the office setting, the Miles test and Dolman method are
easy to perform. During the Miles test, the patient extends
his or her arms to form a circle with both hands that is
centered on an image displayed on the Snellen chart while
both eyes are open. The patient then alternates closing
each eye; the dominant eye is viewing the image with no
image jump. The Dolman method is similar and involves
the patient holding a card with a small central hole with
outstretched arms while viewing a distant object with the
same technique.
Optical dominance can be determined with the lens
fogging technique. First, dial the patient’s refractive error
into the phoropter to provide best-corrected visual acuity
and ask the patient to fixate on an image on the Snellen
chart. Next, add +1.5 D to +2.0 D of sphere power to each
eye individually and ask the patient which eye has more
apparent blur. The eye with more subjective blurriness is
the dominant eye. Conversely, the eye that better tolerates
optical blur is the nondominant eye. Agreement between
these 2 methods varies.4
For some patients, the laterality of the dominant eye
at distance does not correspond with the dominant eye
for near work, considered near dominant. This subset of
patients tends to have more difficulty adjusting to blended
vision. Currently, we do not have a good screening tool to
assess for this discrepancy.
Intraocular Lens Calculations
For RLE, it is essential to obtain precise preopera-
tive measurements of various parameters, especially axial
length and keratometry, for accurate IOL power determina-
tion. The formula(s) should be chosen based on axial length
and post–refractive status. In eyes with prior corneal refrac-
tive surgery, the power calculation is more complicated
and can be less predictable. Further specialized testing
such as anterior segment optical coherence tomography
can be done and intraoperative aberrometry is helpful in
improving accuracy. For calculating astigmatic correc-
tion, in general, we recommend using a weighted mean
of the total astigmatism and the astigmatism axis from
multiple measurements based on the corneal topography/
tomography with Scheimpflug and/or Placido disk-based
technology and optical biometry. Various IOL calculation
formulas from different generations can also be weighted
and averaged to determine the appropriate power. Further
discussion of these methods and techniques are beyond the
scope of this chapter.
Diagnostic Technology
Meticulous preoperative diagnostic testing is the foun-
dation for accurate IOL calculations and optimal refractive
outcomes. With the evolution and advancement of diagnos-
tic technologies, we are now able to better objectively assess
patients who are experiencing symptoms of DLS.
Overview of Refractive Lens Exchange   81
Helpful diagnostic technology includes Scheimpflug
imaging, double-pass retinal imaging, and aberrometry
analysis. Scheimpflug imaging technology can objectively
measure lens density in patients that do not yet show a
decrease in visual acuity testing with the Snellen chart or
Brightness Acuity Tester (Marco). Images are generated by
a slit illumination and a rotating Scheimpflug camera that
rotates 180 degrees around the eye and captures sectional
images of the anterior and posterior corneal surfaces as
well as the anterior segment. The refraction of light at vari-
ous ocular tissue interfaces delineates anatomic features
while differences in brightness provide an indication of
tissue density.5 Transparent layers appear black and tissues
of increasing densities appear incrementally lighter based
on gray-scale image analysis. It has been shown that in
patients with DLS, the crystalline lens gray-scale units on
Scheimpflug imaging show a significantly increased den-
sity over time as compared to phakic, healthy young eyes
without visual complaints.6 The lenticular image captured
by Scheimpflug imaging is an objective way of document-
ing lens density and anterior chamber depth (Figure 8-2).
This imaging modality is very useful for patient education
regarding lens status.
Double-pass wavefront technology is another emerg-
ing diagnostic tool used to assess ocular optical quality.7
The AcuTarget HD Analyzer (Visiometrics) is an Optical
Quality Analysis System (OQAS); an infrared diode laser is
collimated and passed through an entrance aperture before
entering the eye. Laser light reflected from the retina is then
reflected by a beam splitter and captured by a digital cam-
era.8 The captured image is a representation of the amount
of forward light scatter in the eye. This is quantified by an
objective scatter index (OSI) score (Figure 8-3). The OSI is
derived from the ratio of integrated light in the periphery to
that in the central area of the image. OSI scores are around
1 in normal eyes and increase with greater degrees of ocular
scatter. In this manner, lens opacities and cataracts can be
graded objectively compared to the traditional methods
of subjective interpretation by slit lamp examination and
the use of clinical lens grading systems such as the Lens
Opacities Classification System III, which are descriptive
and physician subjective.8-10 The OQAS also provides qual-
itative information with the point spread function, which
simulates the pattern of light projected onto a patient’s
retina (see Figure 8-3). This is particularly useful in under-
standing why some clinically pronounced lens opacities do
not cause much subjective visual disability while other very
small lens changes seem to cause significant visual impair-
ment. Furthermore, the OQAS generates a defocus curve
that demonstrates the degree of accommodative loss.
Multifunctional devices, such as the OPD-Scan II
(Nidek) and iTrace (Tracey Technologies) have the abil-
ity to analyze whole eye and internal aberrations, aid-
ing in the diagnosis of DLS. The OPD-Scan II uses both
Placido disk-based technology and retinal reflection of
infrared light to provide a variety of data maps including
 82  Chapter 8

A B

Figure 8-2. (A) Pentacam Scheimpflug images comparing a patient with a clear lens (top) vs a patient with DLS (bottom). (B) Pentacam images before
(top) and after (bottom) RLE demonstrating increased anterior chamber angle (red lines) and removal of lens opacities postoperatively.

Figure 8-3. Point spread function image and OSI from AcuTarget HD Analyzer.

total refractive error, wavefront higher order aberrations,
corneal topography, internal aberrations, and visual qual-
ity of the eye.11 The iTrace aberrometer and topographer
projects 256 individual light rays through the pupil onto
the retina to measure lower and higher order aberrations.
The wavefront maps facilitate physician analysis of lenticu-
lar contributions to the total eye aberrations by separating
maps of corneal and internal aberrations. In the setting of
a normal retina and vitreous, increased contributions of
internal aberrations to the total eye aberrations may be a
sign of a dysfunctional lens. A noteworthy feature of the
iTrace technology is the Dysfunctional Lens Index (DLI;
Figure 8-4). A number from 0 to 10, the DLI calculation
combines measures of internal higher order aberrations,
analysis of contrast sensitivity, and pupil size dynamics to
aid in the diagnosis of DLS.12
Together, Scheimpflug imaging, double-pass retinal
imaging, and wavefront aberrometry are able to provide
meaningful functional visual analysis beyond that provided
by traditional Snellen visual acuity testing. These devices
are helpful in educating both physicians and patients in
understanding the cause of decreased visual quality and
dysphotopic symptoms in patients with acceptable Snellen
visual acuity testing.
 Overview of Refractive Lens Exchange   83

Figure 8-4. iTrace DLI Display demonstrates the effect of the lens changes upon the patient’s visual system. DLI is based upon
the measured internal higher order aberrations, analysis of contrast sensitivity, and pupil size dynamics. The Opacity Grade is an
assessment of how much energy lands on the retina from 128 sequential and independent lasers sent into the eye. The iTrace
reads the variance and intensity of the energy reaching the retina generating a map of the opacity or scatter graded from 0 to 5.

Instruments such as the Salzburg Reading Desk (SRD; Implant Technology

SRD Vision) represent additional tools developed to objec-
tively measure aspects of visual function other than Snellen
visual acuity. The SRD simulates a natural reading envi-
ronment and calculates distance-corrected logMAR visual
acuity and reading speed at various illumination and con-
trast levels. The SRD may be useful in postoperative assess-
ment of multifocal or accommodative IOL performance.13
As with all premium IOL surgery, using technology to
diagnose and manage ocular surface disease preoperatively
will make for the best refractive results. A multitude of
new diagnostic tools are available for patients that suffer
from ocular surface disease in addition to the traditional
testing options such as a slit lamp exam or Schirmer’s test.
Double-pass retinal imaging can also be used to measure
ocular scatter in an abnormal tear film.14 Tear break-up
time can be measured precisely and noninvasively via
dynamic videography with devices such as the Keratograph
(Oculus),15 while tear film composition can be evaluated
using the TearLab Osmolarity System (TearLab Corp). To
address meibomian gland dysfunction, one clinical tool
available is Lipiview (TearScience), which uses ocular sur-
face interferometry to analyze the lipid layer of the tear
film and image the meibomian glands.16 A functional and
qualitative analysis of the corneal surface and tear film
in patients with DLS will optimize IOL calculations and
refractive outcomes.
Presbyopia can be addressed surgically with monofocal
IOLs for blended vision or with the use of multifocal, accom-
modating, or extended depth of focus IOLs. In patients with
astigmatism, LRIs may be performed or toric IOLs may be
implanted to further help reduce spectacle and contact lens
dependence. LRIs are useful in those with regular astigma-
tism less than 1.5 D of with-the-rule astigmatism, and less
than 0.75 D of against-the-rule astigmatism, while toric
IOLs are useful in those with regular astigmatism of greater
amounts. In the future, we will have access to low-strength
toricity IOLs, which will further increase the use of these
devices in refractive lens surgery. Various LRI nomograms
or online calculators are available to aid in determining
the location and size of the LRI(s) that will most effectively
neutralize the corneal astigmatism. Although LRIs may
be performed manually, the femtosecond laser may create
more precise arcuate incisions for astigmatic correction.
Multifocal, accommodating, and extended range of
vision IOL technology is discussed in further detail in later
chapters.
84  Chapter 8
SURGICAL TECHNIQUES
Manual RLE refers to the surgical removal of the
crystalline lens and placement of the appropriate IOL for
management of DLS without the use of a femtosecond
laser. Femtosecond laser–assisted RLE may have potential
benefits, as discussed earlier (eg, for patients with Fuchs’
dystrophy or for precise astigmatic correction with LRIs).
The authors’ surgical pearls for RLE with toric IOLs
include but are not limited to the following:
▶ Use the femtosecond laser to make small 10-degree
intrastromal arcuate incisions at the toric axis in
place of manual marking. This allows for a more
permanent toric mark, which may be useful in the
postoperative period to verify toric alignment.
▶ Remove the ophthalmic viscosurgical devices
from behind the IOL at the time of viscoelastic
removal because it may reduce the incidence of
toric IOL rotation. In addition, ensure the anterior
capsulorrhexis edge overlaps with the optic edge to
help prevent postoperative IOL tilt or shift. Slight
posterior pressure should be applied to the ante-
rior optic to seat the IOL on the posterior capsule.
Meticulous wound architecture and closure may
aid in minimizing postoperative rotation.
▶ For multifocal or extended depth of focus IOLs,
use the subject-fixated coaxially sighted corneal
light reflex, also known as the Chang-Waring axis.
This reflex is independent of pupillary dilation or
phakic status and results in the best centration of
these IOLs.17
Intraoperative aberrometry can be used as an adjunc-
tive guide to IOL selection or for verification at the time
of surgery and is especially recommended in patients with
a history of corneal refractive procedures. The Optiwave
Refractive Analysis (Alcon Laboratories, Inc) uses wave-
front interferometry to produce a fringe pattern, which is
then analyzed and translated to refractive values and an
estimation of IOL powers.18 One study showed that com-
bined use of the Optiwave Refractive Analysis along with
an online IOL power calculator and conventional formulas
to predict IOL power allowed for better refractive outcomes
than the use of any one method alone.19
Anatomic abnormalities such as nanophthalmos can
increase the risk of intraoperative complications in RLE.
In patients with short eyes or shallow anterior chambers,
the use of a Honan balloon or the administration of intra-
venous mannitol in the preoperative holding area 15 to
30 minutes prior to surgery may be useful. The Honan bal-
loon lowers intraocular pressure via a low external pressure
device. Intravenous mannitol dehydrates the vitreous and
reduces posterior pressure during surgery. These tools may
aid in maintaining a controlled surgical environment dur-
ing removal of the dysfunctional lens.20 Vitreous tap may
be indicated as well.
It should be kept in mind that safe surgery, as with
all surgical procedures, is of utmost importance. If any
difficulty is encountered at the time of surgery, such as a
rupture of the posterior capsule, we feel a monofocal IOL is
indicated instead of the IOL that was chosen preoperatively.
Patients should be advised preoperatively of this possibility
and counseled that blended vision would still be an option
in this scenario.
CONCLUSION
By improving optical quality, addressing presbyopia
and astigmatism, and preventing cataracts, RLE may be
considered an all-in-one surgical option with excellent
visual outcomes and long-term satisfaction. It is likely that
DLS will be more readily recognized and effectively man-
aged due to ever-increasing patient expectations and with
the advent of advancing diagnostic and implant technolo-
gies as well as FLACS. For patients, this will mean address-
ing complaints of presbyopia and declining visual quality
sooner, thereby improving quality of life.
REFERENCES
1. Goldberg DC, Chen JY, Waring G. Biomechanics of accommoda-
tion and presbyopia: dysfunctional lens syndrome. In: Wang MX,
ed. Refractive Lens Exchange: A Surgical Treatment for Presbyopia.
Thorofare, NJ: SLACK Incorporated; 2015:11-19.
2. Schroeder A, Tremblay D, Waring G. Analysis of biometric anterior
chamber parameters using Scheimpflug imaging and IOP after laser
cataract surgery in hyperopic eyes. Paper presented at: American
Society of Cataract and Refractive Surgery; 2015; San Diego, CA.
3. Brundrett AT, Waring GO. Corneal changes in Fuchs endothelial
dystrophy after femtosecond laser-assisted cataract surgery. Paper
presented at American Society of Cataract and Refractive Surgery;
San Diego, CA; 2015.
4. Srinivasan B, Leung HY, Cao H, Liu S, Chen L, Fan AH. Modern
phacoemulsification and intraocular lens implantation (refractive
lens exchange) is safe and effective in treating high myopia. Asia Pac
J Ophthalmol (Phila). 2016;5(6):438-444.
5. Simon F. Pentacam. Kerala Journal of Ophthalmology.
2011;XXIII(2):157-160.
6. Tremblay DW, Waring GO, Din HA. Scheimpflug lens densitometry
as objective measure of crystalline lens opacity. Paper presented at:
American Society of Cataract and Refractive Surgery; 2015; San
Diego, CA.
7. Qiao L, Wan X, Cai X, et al. Comparison of ocular modulation
transfer function determined by a ray-tracing aberrometer and a
double-pass system in early cataract patients. Chin Med J (Engl).
2014;127(19):3454-3458.
8. Artal P, Benito A, Perez GM, et al. An objective scatter index based
on double-pass retinal images of a point source to classify cataracts.
PLoS One. 2011;6(2):e16823.
9. Vilaseca M, Romero MJ, Arjona M, et al. Grading nuclear, corti-
cal and posterior subcapsular cataracts using an objective scat-
ter index measured with a double-pass system. Br J Ophthalmol.
2012;96(9):1204-1210.
10. Chylack LT Jr, Wolfe JK, Singer DM, et al. The Lens Opacities
Classification System III. The Longitudinal Study of Cataract Study
Group. Arch Ophthalmol. 1993;111(6):831-836.

11. NIDEK. OPD-Scan II ARK-1000: Optical Path Difference Scanning
System. NIDEK. http://www.nidek.fr/media/catalogue/MOP0003/
OPD_SCANII.pdf. Published 2006. Accessed June 1, 2018.
12. Tracey Technologies. How can the iTrace help me with patients
experiencing Dysfunctional Lens Syndrome? Tracey Technologies.
http://w w w.tracey technologies.com/Tutorial_DLI_web.pdf.
Published 2015. Accessed June 28, 2018.
13. Attia MSA, Khoramnia R, Auffarth GU, Kirchner M, Holzer MP.
Near and intermediate visual and reading performance of patients
with a multifocal apodized diffractive intraocular lens using an
electronic reading desk. J Cataract Refract Surg. 2016;42(4):582-590.
14. Habay T, Majzoub S, Perrault O, Rousseau C, Pisella PJ. Objective
assessment of the functional impact of dry eye severity on the
quality of vision by double-pass aberrometry. J Fr Ophtalmol.
2014;37(3):188-194.
Overview of Refractive Lens Exchange   85
15. Jiang Y, Ye H, Xu J, Lu Y. Noninvasive keratograph assessment of
tear film break-up time and location in patients with age-related
cataracts and dry eye syndrome. J Int Med Res. 2014;42(2):494-502.
16. TearScience. LipiView: product and safety labeling. Morrisville, NC:
Johnson & Johnson Vision; 2017.
17. Chang D, Waring GO. The subject-fixated coaxially sighted corneal
light reflex: a clinical marker for centration of refractive treatments
and devices. Am J Ophthalmol. 2014;158(5):863-874.
18. Saraiva J, Neatrour K, Waring GO IV. Emerging technology in
refractive cataract surgery. J Ophthalmol. 2016;2016:7309283.
19. Tannan AE, Epstein R, Virasch V, Majmudar P, Faron C, Rubenstein
J. Utility of intraoperative wavefront aberrometry in post-refractive
cataract patients. Invest Ophthalmol Vis Sci. 2013;54(15).
20. Moss HK, Koch DD. Complicated cataract cases: cataract surgery
in the setting of nanophthalmos. EyeWorld News Service. https://
www.eyeworld.org/article-cataract-surgery-in-the-setting-of-nan-
ophthalmos. Published October 2012. Accessed June 1, 2018.

Multifocal Intraocular Lenses
Jay Bansal, MD
Multifocal intraocular lenses (IOLs) have more than
one focal point, which enables them to correct near and far
vision. They traditionally replace the native lens following
cataract or clear lens removal. Multifocal IOLs create 2 or
more retinal images, corresponding to focused light rays
from objects of different distances. Since the retina is pre-
sented with more than one image simultaneously, the patient
must concentrate on an object or task at a particular distance.
TYPES OF MULTIFOCAL
INTRAOCULAR LENSES
Multifocal IOLs have traditionally been separated
into 2 types: diffractive and refractive. These describe the
intrinsic way in which a lens design creates the multiple ret-
inal images. However, many newer lens designs include fea-
tures of both types, making the distinction somewhat less
meaningful. Nevertheless, clinicians should understand the
similarities and differences between these 2 designs since
all existing multifocal IOLs use one or both optic principles.
- 87 -
9
Refractive Multifocal
Intraocular Lenses
Refractive multifocal IOLs possess 2 or more curva-
tures to form refractive zones. Each refraction zone bends
light to form 2 or more retinal images, each with a differ-
ent dioptric power. It can be thought of functioning in the
same way as a bifocal corrective lens. Since each refraction
zone also has a different effective aperture, the performance
of most refractive multifocal IOLs depends, in part, on
pupillary response to light.1 In other words, as the pupil
dilates, the relative proportion of light directed to near and
distant focal points changes (Figure 9-1). Image quality can
depend on the patient’s natural pupil size. People with small
pupils would be expected to have poorer image quality than
people with larger mean pupil size.
Diffractive Multifocal
Intraocular Lenses
Diffractive multifocal IOLs create more than one
retinal image through light diffraction. The surface of a
diffractive IOL possesses microscopic concentric rings, or
diffractive zones, that slow and bend light rays. Each ring
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 87-94).
© 2019 SLACK Incorporated.
88  Chapter 9
Figure 9-1. ReZoom multifocal IOL implant. (Reprinted with permission
from Johnson & Johnson Vision.)
A B
Figure 9-3. (A) TECNIS IOL. (Reprinted with permission from Johnson & Johnson Vision.) (B) TECNIS IOL implanted in the eye. (Reprinted with
permission from Sondra Black, OD.)
creates a discontinuity of optical density that directs a por-
tion of the light energy to both near and far focal points
(Figures 9-2 and 9-3). The result is either 2 or 3 retinal
images in the case of bifocal or trifocal diffractive IOLs,
respectively. Bifocal diffractive IOLs provide patients with
simultaneous near and distant focal points, plus an inter-
mediate focal point in the case of trifocal IOLs.
Diffractive multifocal IOLs may or may not be apodized.
A nonapodized diffractive multifocal IOL contains regularly
sized concentric rings with a uniform height from center to
edge. Thus, for each ring, the optical density is split to the
same extent for near and distant focal points. In an apodized
lens, the diffractive step heights are gradually reduced in
each concentric ring as they extend from the center to the
periphery of the lens. Peripheral rings direct more light rays
(optical density) to the distant focal point compared to the
more central rings. At times in which the pupil is dilated (eg,
during night driving), the resolution of far objects should be
superior at the expense of near vision resolution.
Figure 9-2. ReSTOR diffractive IOL implant. (Reprinted with permission
from Alcon Laboratories, Inc.)
Purely refractive or diffractive IOLs assume rotational
symmetry; however, newer lenses are applying the concept
of rotational asymmetry. Rotationally asymmetric lenses
are divided into sectors or segments that handle light dif-
ferently. Thus, instead of creating the same diffraction or
refraction across the ring or zone, a segment of the lens
provides a different focal point than the rest of the lens.2
In other words, the distance section provides a sharp, high-
contrast image for far vision, and the near section produces
the same for near vision.3,4
IOLs with aspheric designs are intended to reduce
spherical aberrations. Both aspheric and rotationally asym-
metric design features should improve contrast sensitiv-
ity.2,5 Lastly, hybrid diffractive-refractive IOLs attempt to
achieve the best of both designs and extend the functional
visual range of the lens.
In the mid-2000s, attempts were made to advance pha-
kic multifocal IOLs. The goal was to preserve the crystalline
lens and place the multifocal IOL in the anterior chamber.6,7

TABLE 9-1
PATIENT FACTORS THAT PREDICT SATISFACTION
AFTER MULTIFOCAL INTRAOCULAR LENS IMPLANTATION
More Likely to Be Satisfied
▶ Strong desire to be spectacle independent
▶ Moderate to high hyperopia, moderate to high myopia
▶ Ocular issues limited to refraction, presbyopia
▶ The main near task is reading, not computer use
▶ Willing to accept some loss of distance acuity
▶ Generally positive demeanor, will work as partner
▶ Accepts the procedure may not deliver perfect vision
▶ Accepts an adjustment period of up to 6 months
Adapted from Braga-Mele R, Chang D, Dewey S, et al. Multifocal intraocular lenses: relative indications and contraindications for implantation.
J Cataract Refract Surg. 2014;40(2):313-322. doi:10.1016/j.jcrs.2013.12.011; Gibbons A, Ali TK, Waren DP, Donaldson KE. Causes and correction of
dissatisfaction after implantation of presbyopia-correcting intraocular lenses. Clin Ophthalmol. 2016;10:1965-1970. doi:10.2147/opth.s114890.
While visual results were acceptable, anterior placement of
the IOL was associated with various, potentially serious
complications including endophthalmitis, induced astig-
matism, chronic uveitis, pupillary block glaucoma, and
cataract. Thus, development was largely abandoned. Efforts
to develop posterior chamber phakic IOLs for presbyopia
treatment are in the early stages.8
INDICATIONS AND CONSIDERATIONS
Multifocal IOLs were primarily developed as a treat-
ment for aphakia and to correct presbyopia in patients with
cataracts.9 Indeed, multifocal IOL implantation has become
a variation of standard phacoemulsification cataract sur-
gery.10 The other important indications for multifocal IOLs
are in patients with relatively clear crystalline lenses. One
patient population is comprised of people who have high
refractive error due to abnormal ocular anatomy. The other
population is older individuals with presbyopia who have
normal axial length and who wish to be free of spectacles.
Cataract patients and patients with clear lenses are 2 very
different patient populations, however, and the approach
and considerations in each group are quite different.
Refractive lens exchange (RLE) in people with rela-
tively clear lenses offers the possibility of treating myopia
or hyperopia, astigmatism, and presbyopia simultaneously,
while avoiding cataracts in the future. If spectacle inde-
pendence means treating presbyopia and even astigmatism
in addition to myopia or hyperopia, it is a very high bar
indeed. The bar is even higher in patients who are naturally
emmetropic and seeking a surgical solution for presbyopia
that frees them from reading glasses.11-13
Multifocal Intraocular Lenses   89
Less Likely to Be Satisfied
▶ Understands that spectacles may still be needed
▶ Low myopia
▶ Undiscovered pre-existing ocular pathology
▶ Depends heavily on intermediate and/or night vision
▶ Expects sharp focus at all distances
▶ Generally critical demeanor
▶ Expects the procedure to deliver perfect vision
▶ Cannot tolerate waiting 6 months for results
PATIENT SELECTION AND
PREOPERATIVE COUNSELING
Even after an optimal surgical result, patients still may
be dissatisfied with their optical outcomes following IOL
placement. Patient factors and characteristics that may
guide the selection of multifocal IOL implantation candi-
dates are shown in Table 9-1.10,14 When discussing treat-
ment options and obtaining informed consent, patients
should be aware of the risks involved when replacing a
natural lens with a multifocal IOL.
Prospective patients should be aware of the increased
risk of photic phenomena such as glare, halos, monocular
diplopia, and starbursts (Figure 9-4). Patients who expe-
rienced photic phenomena tend to tolerate them within 6
months of surgery.15,16 This may be due, in part, to higher
order (neural) adaptation.17 Photic phenomena are less
objectionable to patients as uncorrected near visual acu-
ity (UNVA) and contrast sensitivity improves despite sta-
ble, residual refractive errors.16,18,19 Indeed, patients who
receive multifocal IOLs generally require a 6-month neuro-
adaptation period to achieve full benefit from the lenses.20
Importantly, most studies considered presbyopia treat-
ment concurrent with cataract phacoemulsification. A per-
son seeking treatment for cataracts is usually quite familiar
with halos and glare, but a person with clear lenses seeking
treatment for refraction errors and presbyopia usually is
not. This may be at least partially managed through candid
presurgical discussions and postsurgical reassurance.
Pupil size is an important consideration in surgical
planning. Patients with large pupils are at an increased risk
for visual disturbances at night.21 As the pupil expands in
90  Chapter 9
Figure 9-4. Multifocal IOLS have an increased risk for glare, halos,
monocular diplopia, and starbursts.
low light, the edges of the pupil interact with the edge of
the treatment zone.22 Various scotopic assessments, such as
pupillometry, can be performed before surgical presbyopia
treatment to determine the relative risk of photic phenom-
ena at night.23 Patients with pupils that are likely to impinge
on the treatment zone can be counseled before the proce-
dure about their increased risk. On the other hand, patients
with small pupils present a technical challenge for surgeons.
The surgeon may need to expand the pupil for capsulorrhex-
is, taking care not to damage the iris sphincter. A decentered
capsulorrhexis leads to a decentered IOL, which interferes
with IOL function and leads to patient dissatisfaction.24
Patients who are seeking treatment to gain spectacle
independence should be warned they may have ongoing
refractive errors and, consequently, may require correc-
tive lenses even after the procedure. Refractive errors that
persist after surgery that were unexpected based on presur-
gical measurements and calculations are called refractive
surprise; however, they occur most often from inaccurate
presurgical assessment or calculation mistakes. Accurate
axial length measurements and lens power calculations are
essential and can greatly reduce the risk of postsurgical
refractive errors.25 Uncommonly, refractive surprise may
be caused by gross error in lens selection. This can be cor-
rected with a second lens exchange procedure, if the patient
is amenable.25 Minor errors of refraction can be corrected
safely and successfully with LASIK.26
It is important to remember that cystoid macular
edema may develop after phacoemulsification and lens
placement. It occurs more commonly after cataract surgery,
but it is also possible after RLE for presbyopia. As with
photic phenomena, people with clear lenses are less forgiv-
ing about cystoid macular edema than cataract patients
are. Cystoid macular edema is more common with poste-
rior capsule rupture, vitreous loss, iris incarceration, active
uveitis, diabetes, and previous retinal vein occlusion.27,28
Topical non-steroidal anti-inflammatory drugs can be both
preventative and curative for cystoid macular edema and
should be used for up to 4 weeks after surgery.29
CONTRAINDICATIONS
Multifocal IOL implantation is an elective procedure.
As such, the risk-benefit ratio must be sufficiently favorable.
The major contraindications to multifocal IOL implan-
tation are related to the relative health of the eye prior
to surgery. Absolute contraindications to multifocal IOL
implantation include complex pupils (eg, eccentric pupil or
iris coloboma), corneal opacity, keratoconus, pellucid mar-
ginal degeneration, corneal ectasia, vitreous opacities that
cannot be corrected, macular disease, retinal drusen and
diabetic retinopathy, retinitis pigmentosa, and Stargardt
disease.10 Macular and retinal diseases not only increase
the risk of suboptimal visual outcomes, the placement of an
IOL impairs the physician’s ability to visualize and track the
disease. In retrospective studies, patients with undiagnosed
presurgical ocular pathology have been relatively dissatis-
fied with the procedure, including patients with Fuchs’
endothelial dystrophy, epiretinal membrane, cystoid macu-
lar edema, age-related macular degeneration, anterior base-
ment membrane dystrophy, or strabismus; these are not
good candidates for the procedure.14 A thorough presurgi-
cal screening can identify patients with these conditions
and counsel them to consider other forms of presbyopia
treatment. Presurgical screening should include corneal
topography and retinal optical coherence tomography.
Any optic nerve abnormality that impairs visual acuity,
contrast sensitivity, color perception, or field of vision may
be a relative contraindication to multifocal IOL implanta-
tion, especially if it is significant and/or progressive.10
Dry eye syndrome and meibomian gland dysfunction
are common in cataract patients, but could be present in
patients undergoing RLE as well.24 Tear film abnormali-
ties can impair visual outcomes and are a common cause
of patient dissatisfaction. Aggressive treatment before and
after surgery can help improve outcomes, however, severe,
uncontrollable dry eye may be a contraindication to multi-
focal IOL placement.
Correctable or symmetrical astigmatism is not neces-
sarily a contraindication to multifocal IOL implantation as
these can be addressed with careful surgical planning.10
People with irregular astigmatism, however, are not good
candidates for multifocal IOL implantation because refrac-
tive outcomes are relatively unpredictable.
OUTCOMES
Visual Acuity and
Spectacle Independence
Outcomes following multifocal IOL implantation are
good to excellent, especially with newer lens designs. In
their meta-analysis, Rosen and colleagues17 reported on
the efficacy and safety of multifocal IOLs following cataract

and RLE. In 6334 patients across 37 included studies, the
mean binocular uncorrected distance visual acuity (UDVA)
was 0.04 ± 0.00 logMAR/Snellen equivalent 20/20. The per-
centage of patients achieving a binocular UDVA of 0.30 log-
MAR/Snellen equivalent 20/40 or better was 99.9% across
5359 patients in 14 studies; 79.2% of patients (5140 patients
across 10 studies) achieved 0.00 logMAR/Snellen equiva-
lent 20/20 or better after multifocal IOL implantation.
Monocular mean UDVA did not differ significantly for
cataract patients (0.11 ± 0.003 logMAR) and RLE patients
(0.05 ± 0.006 logMAR). Taken together, these results show
multifocal IOL implantation results in excellent postopera-
tive distance visual acuity.
The goal for near vision correction in presbyopia
surgery is to be spectacle independent. Rosen and col-
leagues17 found mean spectacle independence was 80.1%. It
should be noted the mean spectacle independence included
newer and older lens designs. Some studies on newer IOL
designs report 100% spectacle independence,30-33 while
older designs such as the Array refractive IOL report 30%
spectacle independence.34
Patient Satisfaction
In general, most patients are satisfied with the results
of multifocal IOL implantation. The most common reasons
that patients are dissatisfied with multifocal IOL implan-
tation are photic phenomena, ongoing or new refractive
error, dry eye, large pupil, and posterior capsule opacifi-
cation.21,24 The most commonly cited reasons for patient
dissatisfaction after clear lens exchange to treat presbyopia
were residual ametropia and dry eye syndrome.14 Patient
satisfaction ratings improve at 6 months after surgery,15,20
presumably due to neuroadaptation.35 In one study of 9366
eyes, patient dissatisfaction led to multifocal IOL explanta-
tion in only 0.44% of cases.36
COMPARING MULTIFOCAL
INTRAOCULAR LENSES
Diffractive and refractive multifocal IOLs improve
UNVA and UDVA in patients treated for cataract, and
are superior to monofocal IOLs across the range of focal
lengths. In terms of UDVA, diffractive and refractive mul-
tifocal IOLs produce roughly equivalent results.37,38 For
UNVA, however, classic diffractive IOLs are consistently
superior to classic refractive lenses.37-40 As mentioned,
spectacle independence is the ultimate goal for presbyopia
surgery, particularly in RLE. Indeed, rates of spectacle
independence are significantly higher with diffractive IOLs
than refractive designs.41 Diffractive designs may also be
Multifocal Intraocular Lenses   91
superior for equivalent intermediate vision. Diffractive
designs may produce less photic phenomena than refrac-
tive IOLs and provide better contrast sensitivity.41 Based
on these results, most surgeons opt for diffractive multifo-
cal IOL designs believing them to be functionally superior.
Indeed, older nonapodized refractive IOLs (eg, ReZoom;
Abbott Medical Optics, now Johnson & Johnson Vision) are
no longer available.
As IOL designs have evolved, the distinction between
diffractive and refractive multifocal IOLs is less pro-
nounced (Table 9-2). Perhaps the best example is the hybrid
diffractive-refractive IOL such as the AT LISA (Carl Zeiss
Meditec) and ReSTOR (Alcon Laboratories, Inc) lens fami-
lies. The AcrySof IQ ReSTOR IOLs, for instance, have an
apodized, diffractive biconvex optic that also handles light
energy like a refractive lens. Some hybrid refractive designs
may deliver better visual acuity outcomes than classic
diffractive lenses.42 Several authors have concluded that
diffractive IOL designs are substantially (up to 1.75 times)
more likely to be associated with spectacle independence
than refractive lenses40; however, the ReSTOR hybrid lens
has been grouped with other pure diffractive lens when
making this calculation. Interestingly, the ReSTOR hybrid
lens rates of spectacle independence is twice that of other
multifocal IOLs. Moreover, rotationally asymmetric refrac-
tive lenses achieve much better spectacle independence
than earlier refractive designs.2,4,43
OPTIMIZING OUTCOMES
Patient selection, testing, and preparation are perhaps
the strongest determinants of patient satisfaction.44 When
patients opt for multifocal IOLs, many expect to be spec-
tacle free after the procedure. Even under ideal preoperative
conditions, 100% spectacle independence is an unrealistic
expectation. Frank conversations with patients can help.
Are they willing to tolerate losses to contrast sensitiv-
ity or halos if it means not needing reading glasses again?
Diffractive lenses may deliver better reading performance
than refractive lens types.39
Carefully consider add power. Early lenses often
favored high lens power (+4.00), yet head-to-head com-
parisons of the ReSTOR lens showed that +3.00 lens power
resulted in similar near and distance vision but superior
intermediate vision with the +3.00 ReSTOR lens.45
Another option to consider is the use of capsular ten-
sion rings. These devices stabilize suboptimal zonules dur-
ing cataract surgery but may be useful in improving centra-
tion of the implanted lens. Studies suggest capsular tension
rings reduce third order aberrations sometimes produced
by multifocal IOLs,46 and help surgeons more accurately
predict patients’ postoperative visual refraction.47
92  Chapter 9

TABLE 9-2
MULTIFOCAL INTRAOCULAR LENSES
Lens Name Manufacturer Approval†
Optical Principle: Refractive
Array* Abbott Medical Optics, now Johnson & Johnson Vision 1997 (FDA)
M-flex Rayner Ltd. 2005 (CE)
SFX MV1 Hoya N/A
PY-60MV Hoya N/A
Sulcoflex Rayner Ltd. 2008 (CE)
ReZoom* Abbott Medical Optics, now Johnson & Johnson Vision 2007 (FDA)
Optical Principle: Rotationally Asymmetric Refractive
LENTIS Mplus Oculentis 2013 (CE)
SBL-3 Lenstec N/A
Optical Principle: Diffractive
Acri.Twin Acri.Tec, now Carl Zeiss Meditec N/A
Acriva Reviol VSY Biotechnology N/A
AT LISA tri 839MP (trifocal) Carl Zeiss Meditec N/A
Bi Flex M Medicontur N/A
CeeOn 811E* Pharmacia, now Johnson & Johnson Vision N/A
FineVision (trifocal) PhysIOL N/A
TECNIS Multifocal Johnson & Johnson Vision 2009 (FDA)
Optical Principle: Hybrid
Acri.Lisa Acri.Tec, now Carl Zeiss Meditec N/A
AcrySof IQ ReSTOR Alcon Laboratories, Inc 2012 (FDA)
AcrySof IQ PanOptix Toric (trifocal) Alcon Laboratories, Inc 2016 (CE)
AT LISA Carl Zeiss Meditec N/A
OptiVis Aaren Scientific (Carl Zeiss Meditec) N/A
* = no longer available
N/A = currently unavailable in the United States
† = If the device has received FDA premarket approval, the year is provided; otherwise, the year of the first CE mark is listed.

Lastly, it can be helpful to reassure patients that neuro-

adaptation to multifocal IOLs takes several weeks, perhaps
months. The concept of neuroadaptive training exercises
is controversial, and data to support their use either before
or after surgery are still lacking. However, the concept of
neuroadaptive training has merit, unlike eye exercises or
other dubious notions. It is conceivable that one would
be able to isolate the factors that influence neuroadapta-
tion to properly select implant candidates. This research
remains in its infancy. In the meantime, some surgeons use
a stepwise approach, choosing to implant a multifocal IOL
in a patient’s nondominant eye, first allowing for sufficient
healing and neuroadaptation time. Once the eye (and brain)
reaches equilibrium, an IOL can be placed in the dominant
eye, using the results of the first implant and new visual
parameters as guides.
REFERENCES
1. Davison JA, Simpson MJ. History and development of the apodized
diffractive intraocular lens. J Cataract Refract Surg. 2006;32(5):849-
858. doi:10.1016/j.jcrs.2006.02.006.
2. Alio JL, Plaza-Puche AB, Piñero DP, Javaloy J, Ayala MJ.
Comparative analysis of the clinical outcomes with 2 multifocal
intraocular lens models with rotational asymmetry. J Cataract
Refract Surg. 2011;37(9):1605-1614. doi:10.1016/j.jcrs.2011.03.054.
3. McAlinden C, Moore JE. Multifocal intraocular lens with a surface-
embedded near section: short-term clinical outcomes. J Cataract
Refract Surg. 2011;37(3):441-445. doi:10.1016/j.jcrs.2010.08.055.
4. Moore JE, McNeely RN, Pazo EE, Moore TC. Rotationally asym-
metric multifocal intraocular lenses: preoperative considerations
and postoperative outcomes. Curr Opin Ophthalmol. 2017;28(1):9-
15. doi:10.1097/icu.0000000000000339.
5. Kim MJ, Zheleznyak L, MacRae S, Tchah H, Yoon G. Objective
evaluation of through-focus optical performance of presbyopia-cor-
recting intraocular lenses using an optical bench system. J Cataract
Refract Surg. 2011;37(7):1305-1312.

6. Baikoff G, Matach G, Fontaine A, Ferraz C, Spera C. Correction
of presbyopia with refractive multifocal phakic intraocular lens-
es. J Cataract Refract Surg. 2004;30(7):1454-1460. doi:10.1016/j.
jcrs.2003.12.051.
7. Alio JL, Mulet ME. Presbyopia correction with an anterior
chamber phakic multifocal intraocular lens. Ophthalmology.
2005;112(8):1368-1374. doi:10.1016/j.ophtha.2005.02.029.
8. Perez-Vives C, Ferrer-Blasco T, Cervino-Exposito A, Madrid-Costa
D, Montes-Mico R. Simulated prototype of posterior chamber pha-
kic intraocular lens for presbyopia correction. J Cataract Refract
Surg. 2015;41(10):2266-2273. doi:10.1016/j.jcrs.2015.10.050.
9. Buznego C, Trattler WB. Presbyopia-correcting intraocular
lenses. Curr Opin Ophthalmol. 2009;20(1):13-18. doi:10.1097/
ICU.0b013e32831c4cf5.
10. Braga-Mele R, Chang D, Dewey S, et al. Multifocal intraocular
lenses: relative indications and contraindications for implanta-
tion. J Cataract Refract Surg. 2014;40(2):313-322. doi:10.1016/j.
jcrs.2013.12.011.
11. Venter JA, Pelouskova M, Bull CE, Schallhorn SC, Hannan SJ.
Visual outcomes and patient satisfaction with a rotational asymmet-
ric refractive intraocular lens for emmetropic presbyopia. J Cataract
Refract Surg. 2015;41(3):585-593. doi:10.1016/j.jcrs.2014.06.035.
12. Alfonso JF, Fernandez-Vega L, Valcarcel B, Ferrer-Blasco T, Montes-
Mico R. Outcomes and patient satisfaction after presbyopic bilateral
lens exchange with the ResTOR IOL in emmetropic patients. J Refract
Surg. 2010;26(12):927-933. doi:10.3928/1081597x-20100114-01.
13. Pepose JS. Maximizing satisfaction with presbyopia-correct-
ing intraocular lenses: the missing links. Am J Ophthalmol.
2008;146(5):641-648. doi:10.1016/j.ajo.2008.07.033.
14. Gibbons A, Ali TK, Waren DP, Donaldson KE. Causes and correc-
tion of dissatisfaction after implantation of presbyopia-correcting
intraocular lenses. Clin Ophthalmol. 2016;10:1965-1970. doi:10.2147/
opth.s114890.
15. Sood P, Woodward MA. Patient acceptability of the Tecnis multifo-
cal intraocular lens. Clin Ophthalmol. 2011;5:403-410. doi:10.2147/
opth.s11126.
16. Forte R, Ursoleo P. The ReZoom multifocal intraocular lens: 2-year
follow-up. Eur J Ophthalmol. 2009;19(3):380-383.
17. Rosen E, Alio JL, Dick HB, Dell S, Slade S. Efficacy and safety of
multifocal intraocular lenses following cataract and refractive lens
exchange: metaanalysis of peer-reviewed publications. J Cataract
Refract Surg. 2016;42(2):310-328. doi:10.1016/j.jcrs.2016.01.014.
18. Anton A, Böhringer D, Bach M, Reinhard T, Birnbaum F. Contrast
sensitivity with bifocal intraocular lenses is halved, as measured
with the Freiburg Vision Test (FrACT), yet patients are happy.
Graefes Arch Clin Exp Ophthalmol. 2014;252(3):539-544. doi:10.1007/
s00417-014-2565-y.
19. Goes FJ. Visual results following implantation of a refractive multi-
focal IOL in one eye and a diffractive multifocal IOL in the contra-
lateral eye. J Refract Surg. 2008;24(3):300-305.
20. Palomino Bautista C, Carmona Gonzalez D, Castillo Gomez A,
Bescos JA. Evolution of visual performance in 250 eyes implant-
ed with the Tecnis ZM900 multifocal IOL. Eur J Ophthalmol.
2009;19(5):762-768.
21. de Vries NE, Webers CAB, Touwslager WRH, et al. Dissatisfaction
after implantation of multifocal intraocular lenses. J Cataract
Refract Surg. 2011;37(5):859-865. doi:10.1016/j.jcrs.2010.11.032.
22. Martinez CE, Applegate RA, Klyce SD, McDonald MB, Medina
JP, Howland HC. Effect of pupillary dilation on corneal optical
aberrations after photorefractive keratectomy. Arch Ophthalmol.
1998;116(8):1053-1062.
23. Schumer DJ, Bains HS, Brown KL. Dark-adapted pupil
sizes in a prospective evaluation of laser in situ keratomile-
usis patients. J Refract Surg. 2000;16(suppl 2):S239-S241.
doi:10.3928/1081-597x-20000302-08.
24. Woodward MA, Randleman JB, Stulting RD. Dissatisfaction after
multifocal intraocular lens implantation. J Cataract Refract Surg.
2009;35(6):992-997. doi:10.1016/j.jcrs.2009.01.031.
Multifocal Intraocular Lenses   93
25. Hoffman RS, Fine IH, Packer M. Refractive lens exchange as a refrac-
tive surgery modality. Curr Opin Ophthalmol. 2004;15(1):22-28.
26. Fernandez-Buenaga R, Alio JL, Perez Ardoy AL, Quesada AL,
Pinilla-Cortes L, Barraquer RI. Resolving refractive error after
cataract surgery: IOL exchange, piggyback lens, or LASIK. J Refract
Surg. 2013;29(10):676-683. doi:10.3928/1081597x-20130826-01.
27. Henderson BA, Kim JY, Ament CS, Ferrufino-Ponce ZK, Grabowska
A, Cremers SL. Clinical pseudophakic cystoid macular edema. Risk
factors for development and duration after treatment. J Cataract
Refract Surg. 2007;33(9):1550-1558. doi:10.1016/j.jcrs.2007.05.013.
28. Ray S, D’Amico DJ. Pseudophakic cystoid macular edema. Semin
Ophthalmol. 2002;17(3-4):167-180.
29. O’Brien TP. Emerging guidelines for use of NSAID therapy
to optimize cataract surgery patient care. Curr Med Res Opin.
2005;21(7):1131-1137. doi:10.1185/030079905x50651.
30. Chang JS, Ng JC, Lau SY. Visual outcomes and patient satisfaction
after presbyopic lens exchange with a diffractive multifocal intra-
ocular lens. J Refract Surg. 2012;28(7):468-474. doi:10.3928/108159
7x-20120612-01.
31. Hida WT, Motta AF, Kara-Jose Junior N, et al. Comparison between
OPD-Scan results and visual outcomes of monofocal and multifocal
intraocular lenses. Arq Bras Oftalmol. 2009;72(4):526-532.
32. Lubinski W, Podboraczynska-Jodko K, Gronkowska-Serafin J,
Karczewicz D. Visual outcomes three and six months after implan-
tation of diffractive and refractive multifocal IOL combinations.
Klin Oczna. 2011;113(7-9):209-215.
33. Vryghem JC, Heireman S. Visual performance after the implanta-
tion of a new trifocal intraocular lens. Clin Ophthalmol. 2013;7:1957-
1965. doi:10.2147/opth.s44415.
34. Pineda-Fernandez A, Jaramillo J, Celis V, et al. Refractive out-
comes after bilateral multifocal intraocular lens implanta-
tion. J Cataract Refract Surg. 2004;30(3):685-688. doi:10.1016/
s0886-3350(03)00664-3.
35. Pepin SM. Neuroadaptation of presbyopia-correcting intraocu-
lar lenses. Curr Opin Ophthalmol. 2008;19(1):10-12. doi:10.1097/
ICU.0b013e3282f31758.
36. Venter JA, Pelouskova M, Collins BM, Schallhorn SC, Hannan SJ.
Visual outcomes and patient satisfaction in 9366 eyes using a refrac-
tive segmented multifocal intraocular lens. J Cataract Refract Surg.
2013;39(10):1477-1484. doi:10.1016/j.jcrs.2013.03.035.
37. Rasp M, Bachernegg A, Seyeddain O, et al. Bilateral reading per-
formance of 4 multifocal intraocular lens models and a monofocal
intraocular lens under bright lighting conditions. J Cataract Refract
Surg. 2012;38(11):1950-1961. doi:10.1016/j.jcrs.2012.07.027.
38. Alio JL, Grabner G, Plaza-Puche AB, et al. Postoperative bilateral
reading performance with 4 intraocular lens models: six-month
results. J Cataract Refract Surg. 2011;37(5):842-852. doi:10.1016/j.
jcrs.2010.11.039.
39. Agresta B, Knorz MC, Kohnen T, Donatti C, Jackson D. Distance
and near visual acuity improvement after implantation of multifo-
cal intraocular lenses in cataract patients with presbyopia: a sys-
tematic review. J Refract Surg. 2012;28(6):426-435. doi:10.3928/108
1597x-20120518-06.
40. Cochener B, Lafuma A, Khoshnood B, Courouve L, Berdeaux G.
Comparison of outcomes with multifocal intraocular lenses: a meta-
analysis. Clin Ophthalmol. 2011;5:45-56. doi:10.2147/opth.s14325.
41. Xu X, Zhu MM, Zou HD. Refractive versus diffractive multifocal
intraocular lenses in cataract surgery: a meta-analysis of random-
ized controlled trials. J Refract Surg. 2014;30(9):634-644.
42. Pepose JS, Qazi MA, Chu R, Stahl J. A prospective randomized
clinical evaluation of 3 presbyopia-correcting intraocular lenses
after cataract extraction. Am J Ophthalmol. 2014;158(3):436-446
e431. doi:10.1016/j.ajo.2014.06.003.
43. Munoz G, Albarrán-Diego C, Ferrer-Blasco T, Sakla HF, García-
Lázaro S. Visual function after bilateral implantation of a new zonal
refractive aspheric multifocal intraocular lens. J Cataract Refract
Surg. 2011;37(11):2043-2052.
94  Chapter 9
44. Liu JW, Haw WW. Optimizing outcomes of multifocal intra-
ocular lenses. Curr Opin Ophthalmol. 2014;25(1):44-48. doi:10.1097/
icu.0000000000000012.
45. Santhiago MR, Wilson SE, Netto MV, et al. Modulation transfer
function and optical quality after bilateral implantation of a +3.00 D
versus a +4.00 D multifocal intraocular lens. J Cataract Refract Surg.
2012;38(2):215-220. doi:10.1016/j.jcrs.2011.08.029.
46. Mastropasqua R, Toto L, Vecchiarino L, Falconio G, Nicola MD,
Mastropasqua A. Multifocal IOL implant with or without capsular
tension ring: study of wavefront error and visual performance. Eur J
Ophthalmol. 2013;23(4):510-517. doi:10.5301/ejo.5000258.
47. Alio JL, Plaza-Puche AB, Pinero DP. Rotationally asymmetric
multifocal IOL implantation with and without capsular tension
ring: refractive and visual outcomes and intraocular optical per-
formance. J Refract Surg. 2012;28(4):253-258. doi:10.3928/108159
7X-20120314-01.

Accommodating
Intraocular Lenses
David Varssano, MD
An accommodating intraocular lens (IOL) is associated
with a dynamic increase in dioptric power with an effort to
refocus from distance to near or to intermediate vergence.1,2
Ideally, a true accommodating IOL has a single focal point
in a static position, similar to a traditional monofocal IOL.
The ability to see well at different distances emerges solely
from physical changes in the lens as a result of the accom-
modative effort of the person implanted with the lens. A
truly accommodative IOL has the potential to create a clear
and sharp retinal image, unlike multifocal IOLs, which cre-
ate multiple images, and serve as the best replacement for
the aging crystalline lens. As discussed later, to achieve the
goal of dynamically changing optical power, several meth-
ods were suggested. Some designs were brought to market,
and some are still being used. As seen later, the full promise
of the accommodating IOL is still to be delivered.
Nonaccommodating factors such as miosis and induc-
tion of higher order aberrations may enhance depth of field,
improving intermediate and near vision in both accom-
modating and monofocal IOLs. Some of the visual benefit
of accommodating IOLs is based on pseudoaccommoda-
tive factors, as patients cannot discriminate between true
accommodation and pseudoaccommodation. Subjective
pushup tests or defocus curve determination may fre-
quently overestimate the objective measures of amplitude
of accommodation.1,3
- 95 -
10
PRINCIPLES OF ACCOMMODATING
INTRAOCULAR LENSES
There are several principles of accommodating IOLs
aimed to produce change in the optical power of the IOL
through the patient’s accommodative effort (Table 10-1).
Small space constraints, forces, and movements the normal
eye uses for natural accommodation forced lens designers
to be innovative, leading them to incorporate various fields
of science.
Hinge or lever IOLs use the contraction and relaxation
of the ciliary muscle to produce accommodation by mov-
ing the IOL forward, directly or through posterior vitreous
pressure, causing a myopic refractive change to improve
near vision. The lens itself is not being deformed. Single-
lens versions are a popular lens design.4-9
Dual-lens design (doublet) IOLs use a combination of 2
juxtaposed lenses, whose combination produces the desired
IOL power. When mathematically evaluating the ability to
produce accommodation with movement of the lenses,10 it
appears that a single moving lens is more efficient in terms
of diopters (D) per mm of motion than a combination of
plus lenses, while a combination of a front plus and a back
minus lens is most efficient. The larger the front plus lens
power and the more negative the back minus lens power
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 95-102).
© 2019 SLACK Incorporated.
96  Chapter 10

ACCOMMODATIVE INTRAOCULAR LENS DESIGNS
Single-Lens Lever Design
▶ BioComFold (Morcher GmbH)
▶ 1CU (HumanOptics AG)
▶ Crystalens (Bausch + Lomb)
▶ Trulign toric IOL (Bausch + Lomb)
▶ C-Well (Acuity)
▶ Tek-Clear (Tekia)
▶ OPAL-A (HumanOptics AG)
▶ KH-3500/Tetraflex (Lenstec)
TABLE 10-1
Dual-Lens Design Liquid/Gel Shift
▶ Spring IOL ▶ NuLens DynaCurve (Nulens Ltd)
▶ Synchrony dual-optic ▶ Valved deformable liquid balloon
accommodating IOL ▶ IOL refilling procedure
(Johnson & Johnson Vision) ▶ Extruded gel interface IOL
▶ Sarfarazi Elliptical Accommodative ▶ FluidVision IOL (PowerVision)
IOL (Bausch + Lomb)
▶ Lumina (AkkoLens International)

in the combination, the higher the efficiency. Leng et al10
calculated that for a 20.0-D combination, to achieve a 3.0-D
add, a single lens would move 2.479 mm, a +10.0 D and
+10.0 D combination would move 5.122 mm, and a +45.0 D
and a -25.0 D combination would move 0.949 mm.
The concept of refilling the emptied capsular bag with
an optically elastic material is the basis for fluid or gel
models. Polysiloxane11,12 and silicone oil13 were suggested
as candidate materials for this purpose. More investigation
is needed to form a complete solution, including a means to
empty the capsular bag, fill it, and seal it.
A biomimetic accommodating IOL using a deformable
liquid balloon has been proposed.14 A balloon inserted into
an emptied capsular bag through a small peripheral capsu-
lorrhexis is filled through a valved detachable tube with a
high refractive index fluid (n = 1.4). Previously presbyopic
human cadaver eyes were able to accommodate between
2.0 D to 7.4 D after lens implantation.14
A proposed method involved membranes to block cap-
sulorrhexis.15 A membrane was placed in the capsular bag
of young monkeys behind the capsulorrhexis and silicone
oil injected behind it through a preplaced hole in the mem-
brane.13 Accommodation of 2.0 D to 3.0 D was recorded in
response to pilocarpine 4% eye drops.
Another gel-based design consists of a flexible gel
contained in a small chamber attached to the eye wall in a
fixed position.16-18 As the ciliary muscle constricts, flexible
gel is pushed through a round hole to form a bulging lens.
Tested in human eyes,16 pilocarpine could induce 10.0 D of
accommodation in that design. Flow of silicone oil between
hollow haptics and the optic is a similar concept. Change of
optic curvature creates accommodation. Such lenses were
examined upon rabbits.19,20
Deforming the interface between 2 fluids or gels with
forces available in the ciliary body can achieve acceptable
accommodation. Two groups used this principle for their
designs.21,22
Changing the shape of the IOL using more rigid mate-
rials has been proposed using 2 designs. In a sliding-type
IOL23 composed of 2 optical elements, the elements slide
over each other, changing their composite optical power by
1.27 D ± 0.76 D with accommodation stimulus. A rotating
focus mechanism24 around an axis that is parallel to and
decentered from the optical axis demonstrated 8.0 D of
accommodation in a lab setting.
A voltage-controlled accommodating IOL made of an
ionic polymer metal composite actuator was tested in vitro
to deform an attached lens.25
In a prototype-based liquid-crystals, accommodation
could be produced by changing the refractive index with
no moving parts.26
ACCOMMODATING INTRAOCULAR
LENSES: PAST AND PRESENT
Early Attempts
Miller27 first discussed the concept of accommodat-
ing IOLs in the 1980s. By the end of the decade, monofocal
IOLs were tested using A-scan ultrasound and an ante-
rior movement was measured during accommodation. The
movement was by 0.7 mm6 for single-piece silicone plate
haptic lenses and 0.20 to 0.25 mm for standard looped
IOLs.28 In 1990 and 1992, Hara and colleagues reported on
the spring IOL.29,30 It consisted of two 6.0-mm optics, held
apart by 4 flexible loops. Accommodative effort was sup-
posed to move the lenses apart to create a refractive change.
The lenses were built and implanted in rabbit eyes.
Cumming and Kammann31 published the first report
of clinical experience with an accommodating IOL in
human eyes in 1996. The first lenses were implanted in
cataract patients in early 1991. Using pilocarpine drops and
a defocus technique, the authors were able to measure an
average of 2.75 D (range 1.25 D to 3.5 D) accommodation
in one lens design. They confirmed the lens motion using
A-scan measurements.
The next attempt was the BioComFold IOL, a single-
piece accommodating hydrophilic acrylic IOL with an
overall disk-shape configuration and a single optic flanked
by 2 semicircular ring haptics.32 Its overall length is 10.0
mm and its biconvex optic is 5.8 mm. A peripheral bulg-
ing ring was connected to the optic via an intermediate,

forward-angled (10-degree) perforated ring section. To
achieve an accommodative effect, the curvature of this disc
IOL must move forward. The lens was implanted in human
eyes in 1997.4 It allowed greater forward shifts than mono-
focal IOLs, but failed to produce pseudoaccommodation
amplitudes greater than the control standard IOL group.
Years later, some of these lenses became opacified with cal-
cification of the lens material.33,34
1CU Accommodating Intraocular Lens
The 1CU accommodating IOL was tested and popu-
larized in Europe. The 1CU IOL is a single-piece biconvex
foldable hydrophilic acrylic posterior chamber IOL. It has a
5.5-mm diameter spherical optic, a 9.8-mm total diameter,
and 4 haptics.5 It is made of a hydrophilic acrylic with an
ultraviolet inhibitor and has a refractive index of 1.46. The
lens has a biconvex square-edged optic and 4 modified
flexible haptics that bend when constricted by the capsular
bag after ciliary muscle contraction. This allows anterior
displacement of the optic.35 The first human use of the 1CU
IOL was reported in 2001,36 on 6 eyes of 6 patients.
In another trial, 30 patients received 1CU in one eye
and a monofocal control in the other. In the 20 available for
evaluation, accommodation induced a small anterior move-
ment of the 1CU (0.010 mm ± 0.028 SD). Pilocarpine 4%
induced a forward movement of 0.220 ± 0.169 mm in the 1CU
compared to a backward movement of 0.028 ± 0.095 mm
with the monofocal lens.37 The amount of the IOL shift was
not sufficient to provide useful near vision, but the differ-
ence suggests that the engineering concept behind the 1CU
IOL is valid.
Eighteen months after bilateral implantation in 30
patients,38 distance-corrected near visual acuity (DCNVA;
logMAR) was 0.57 ± 0.12 compared to the control monofo-
cal IOL 0.69 ± 0.12 (P = .043). The difference between the
1CU and monofocal control group means were 0.46 D for
subjective near point and 0.32 D for defocusing.
Four years after implantation in 12 eyes of 8 patients,
DCNVA (logMAR) was 0.50 ± 0.25 while corrected distance
visual acuity was -0.10 ± 0.06.5 The mean subjective accom-
modation amplitude assessed using a D’Acomo dioptric
accommodator (World Optical Corp Ltd) at 4 years was
1.36 D ± 0.89 D. The mean objective accommodation ampli-
tude measured using an AA-1 accommodation analyzer
(Nidek Inc) was only 0.68 D ± 0.49 D.
Capsular block syndrome was reported with the 1CU,39
and successfully treated with YAG (yttrium-aluminum-
garnet) laser anterior capsulotomy.
Crystalens
The Crystalens AT-45 (eyeonics Inc, now
Bausch + Lomb) hinge/lever silicone accommodating IOL
was first reported in 20016 while being examined by the
Food and Drug Administration (FDA). This lens received
Accommodating Intraocular Lenses   97
US FDA approval in November 2003 for correction of apha-
kia. FDA approval for correction of presbyopia following
cataract extraction and to provide near, intermediate, and
distance vision without spectacles was obtained in August
2004.40 It is a biconvex lens with a 4.5-mm optic and flex-
ible hinged-plate haptics that allow forward movement of
the optic during accommodative effort. The lens design
incorporates hinges across the plates adjacent to the lens
optic that allow for forward and backward movement of
plate-haptic lenses against the vitreous face.
When the Crystalens AT-45 was tested for FDA approv-
al,40 it was implanted in 415 eyes of 263 patients and fol-
lowed for 1 year. Near visual acuity was measured at 40 cm
with the distance correction. Intermediate visual acuity was
measured at 80 cm with distance correction. Combined
uncorrected distance and uncorrected near visual acuity of
20/40 or better was achieved by 78.8% of eyes and 96.7% of
patients at 1 year.
Near acuity measured through the distance correction
was 20/25 or better in 24.8% of eyes, and 20/40 or better in
90.1% of eyes at 1 year.
Best-corrected distance visual acuity of 20/25 or bet-
ter was achieved by 97% of eyes and 20/40 or better was
achieved by 99.2% of the eyes. The DCNVA with the
Crystalens HD (Baush + Lomb) is marginally better (P = .05)
than with a monofocal IOL.41 In contrast, DCNVA with the
Crystalens AT-45 was J3 (Jaeger) or better in more than 60%
of 25 operated eyes in an uncontrolled study.42
When tested in 20 eyes of 10 patients with ante-
rior segment optical coherence tomography (OCT),43 the
Crystalens AO did not shift systematically with accommo-
dative effort, with 9 lenses moving forward and 11 lenses
moving backward (under natural conditions). The average
shift under stimulated accommodation with pilocarpine
was -0.02 ± 0.20 mm. When IOL movement was measured
by partial coherence interferometry after 2.0 D stimulation,
pilocarpine and cyclopentolate, the conclusion was that the
mechanism of action of the Crystalens HD IOL was not
primarily from IOL movement.44 The Crystalens HD did
not change the refraction with accommodative effort in a
group of 10 patients.45
The Crystalens HD 500 accommodating IOL also had
decreased distance image quality and slightly increased
depth of focus compared with the monofocal IOLs because
of the bispheric design.46 Cases of Z syndrome were report-
ed with the Crystalens (AT50SE, AT52SE, and AT-45) after
uneventful cataract surgery. Neodymium:YAG laser capsu-
lotomy treatment can resolve the complication.47,48
Dual-Optic Accommodating
Intraocular Lenses
Sarfarazi Elliptical Accommodative IOL was licensed
by Bausch + Lomb in 2003.49,50 It is formed by 2 optic
lenses of 5.0 mm in diameter connected by 3 haptics, which
98  Chapter 10
produces accommodation through anterior displacement of
the anterior optic. Its elliptical shape has been designed in
order to conform to the natural morphology of the crystal-
line lens capsule. The lens induces an increase in accom-
modative amplitude of approximately 6.0 D in primates,
and was predicted to induce 4.0 D in humans. There are
no studies in the literature showing the effectiveness of this
IOL in humans.
At the same time the Crystalens was being investigat-
ed, a dual-optic accommodating IOL model was produced
and placed in a cadaver eye in 2003.51 A similar lens design,
now named the Synchrony dual-optic accommodating IOL,
was placed in rabbit eyes in 200452 and implanted in human
eyes by 2006.53,54
Synchrony Dual-Optic
Accommodating Intraocular Lens
The Synchrony dual-optic accommodating IOL 49 has 2
optical lenses located within the capsular bag. The haptics
are placed in the sulcus. It is available in powers ranging
from +16.0 D to +28.0 D in steps of +0.5 D with a total
length of 9.5 mm and 9.8 mm wide. The +32.0 D anterior
optical lens has a diameter of 5.5 mm and is connected
through the spring haptic to the 6.0-mm negative-pow-
ered posterior optical lens. The haptics of the Synchrony
dual-optic accommodating IOL were designed to permit
a displacement of 1.5 mm of the anterior optic with the
ciliary body contraction. The Synchrony dual-optic accom-
modating IOL has had CE approval since 2006. It can be
injected through a 3.8- to 4.0-mm incision, depending on
the dioptric power.
In a prospective noncomparative case series,54 23 of 24
eyes (96%) had 20/40 or better DCNVA. In a prospective
multicenter clinical study with Synchrony Vu (Johnson &
Johnson Vision)55 on 74 patients (148 eyes), clinical data at
6 months showed 89% of the eyes within ±1.0 D planned
spherical equivalent refraction. Mean binocular uncor-
rected and corrected distance visual acuity was 20/20 at far,
20/20 at intermediate, and 20/25 at near. Mesopic contrast
sensitivity was within normal limits. Seventy-eight percent
of the patients had no spectacles. Dysphotopsia was present
at 30%. One eye had IOL repositioning within 1 month of
surgery. Good distance-corrected near reading ability at
40 cm of 0.07 logMAR was maintained for at least 2 years.56
Aberrometry while using an accommodative stimulus of
3.0 D revealed accommodation of approximately 1.0 D with
a pupil size of 3.0 mm 4.5 years postoperatively.57
Comparison between a single-optic accommodating
IOL (Crystalens HD) and a dual-optic accommodating IOL
(Synchrony) in patients after cataract surgery concluded
that both IOLs restored distance visual function after
cataract surgery with limitations in near visual outcomes.
Eyes with the dual-optic IOL had significantly better ocular
optical quality.58
Pars plana vitrectomy for epiretinal membrane remov-
al was performed in the presence of a Synchrony dual-optic
accommodating IOL.59 During pars plana vitrectomy, visu-
alization of the macula was described as perfect.
NuLens
Ben-Nun and Alio17 first reported in 2005 of a new
lens design, later to be named NuLens. This lens consists
of a flexible gel contained in a small chamber attached to
the eye wall in fixed position.16,18 A piston operated by the
empty, collapsed capsular bag pushes the contained flexible
gel through a round hole to form a bulge that functions as a
lens; the steeper the bulge, the stronger the lens. As the cili-
ary muscles respond to the naturally occurring retinal-brain
blur stimulus, they apply force to the piston via the capsular
diaphragm. This force deforms the silicone gel curvature
until the best image is achieved on the retina at any given
distance, creating a dynamic high-power lens. A clinical
report of the NuLens implanted in 10 patients with atrophic
macular degeneration was published in 2009.16 Pilocarpine
induced changes in ultrasound biomicroscopy cross-section
of the IOL and the measured best reading distance suggest
that the lens could achieve 10.0 D of accommodation.
Tetraflex
Human implantation of another lens design, the
KH-3500, was first reported in an article published in
2006.60 The KH-3500 IOL, later named Tetraflex,7 is a
single-piece, spherical, acrylic IOL with refractive index of
1.46. The central optic portion is 5.75 mm and the overall
size 12.0 mm in diameter.60 It has a flexible haptic that
is designed to allow the whole lens to move anteriorly in
the capsular bag secondary to ciliary muscle contraction,
unlike the hinged haptics in other designs. The KH-3500
has limited objective accommodating effects.
In a prospective, age-matched, nonrandomized FDA
clinical trial, Tetraflex was compared to a control mono-
focal IOL.61 Seventy-five percent of the Tetraflex patients
reported near spectacle wear either never or only occasion-
ally for small print and/or dim light (21% never) compared
with 46% of control patients (P < .001; 9% never) at 1 year
postoperatively.
In a noncontrolled study of 50 eyes implanted with the
Tetraflex,62 the mean subjective accommodation was 0.94 D
and mean pilocarpine-induced IOL mobility was 337 μm.
In 28 participants implanted with the KH-3500 mon-
ocularly, accommodation was 0.39 D ± 0.53 D measured
objectively using the SRW-5000 (Shin-Nippon Commerce
Inc) through undilated pupils and was 3.1 D ± 1.6 D mea-
sured subjectively with a Royal Air Force binocular gauge
(Clement Clarke/Haag-Streit).60
The Tetraflex appeared not to move forward upon
accommodation63 when examined with an anterior

segment OCT. Near vision benefits may be due to changes
in the optical aberrations because of the flexure of the IOL
on accommodative effort.
In a series of 95 eyes of 59 patients implanted with the
Tetraflex,7 89.3% achieved a DCNVA of 20/40 or better at 6
months after surgery.
Patients implanted with Tetraflex IOL had bet-
ter DCNVA and greater amplitude of accommodation
(1.99 D ± 0.58 D vs 1.59 D ± 0.45 D, P < .05) compared with
the control group that had nonaccommodating IOLs.64
When measured with a spectral-domain OCT at
relaxed and maximal accommodative states, the Tetraflex
showed a forward movement in 69.6%, more than in the
control group (P < .001). However, the authors concluded
that the slight forward axial shifts of the Tetraflex IOL dur-
ing natural accommodation may not produce a clinically
relevant change in optical power.
Tetraflex was used in a study on 24 patients.64 At 3
months, uncorrected distance visual acuity (logMAR)
was 0.26 ± 0.14, best-corrected distance visual acuity was
0.22 ± 0.11, uncorrected near visual acuity was 0.27 ± 0.15,
and DCNVA was 0.24 ± 0.12. Subjective accommodation
(D) measured with a defocus method was 1.54 ± 0.39 and
objective accommodation (D) measured with the Optical
Quality Analysis System (Visiometrics) was 1.27 ± 0.41
(0.75 to 2.25). Forward movement measured with ante-
rior segment OCT (Visante-1000, Carl Zeiss Meditec) was
130.46 ± 42.71 μm.
In 2016, Li et al64 reported a good correlation between
lens shift induced by pilocarpine before surgery and postop-
erative IOL shift under accommodation stimulus, subjective
accommodation, and objective accommodation, following
implantation of the Tetraflex IOL. This is a new predictive
factor for surgical success with accommodative IOLs.
In a retrospective study comparing Tetraflex, a refrac-
tive multifocal IOL (ReZoom; Abbott Medical Optics, now
Johnson & Johnson Vision), and a diffractive multifocal
IOL (ZMA00; Abbott Medical Optics, now Johnson &
Johnson Vision),65 no statistically significant differences
were found in uncorrected and corrected distance visual
acuity and uncorrected intermediate visual acuity among
the groups (P = .39). The Tetraflex had similar distance-
corrected intermediate visual acuity as the other lenses. It
had significantly worse near visual acuity than the ZMA00
group (P < .05). Better contrast sensitivity values were
observed in the Tetraflex group under most of the spatial
frequencies conditions (P = .025). The total aberration was
lowest in the ZMA00 group (P = .000), and the spherical
aberration was highest in the Tetraflex group (P = .000). The
3 groups had similar frequency of ghosting and glare, and
the Tetraflex group had a lower rate of halos (P = .01).
An in-the-bag subluxation of the hydrophilic acrylic
Tetraflex accommodating IOL following capsulorrhexis
phimosis was reported.66 Explantation of the IOL-capsular
Accommodating Intraocular Lenses   99
bag complex was required 7 years after implantation.
Histopathologic analysis demonstrated multiple areas of
thick anterior subcapsular fibrosis and pseudoexfoliative
material.
Tek-Clear
Another single-optic design, the Tekia Tek-Clear,50,67
has been approved for treatment of presbyopia by the
European Commission since 2006. This accommodating
hydrophilic acrylic IOL has symmetric optic design, ultra-
violet blocker, and square edge design. Patients using the
Tek-Clear lens achieved DCNVA of 0.25 ± 0.23 logMAR
as opposed to 0.49 ± 0.1 with a standard monofocal lens
(P < .001).67
Other Developmental Lenses
It has been suggested that since the refractive power
of a lens is derived from its physical shape and refrac-
tive index, changing the refractive index would create an
accommodating lens that has no moving parts. Simonov et
al26 presented in 2007 a prototype of an adaptive IOL based
on a modal liquid-crystal spatial phase modulator with
wireless control.
The concept of refilling the emptied capsular bag with
an elastic clear refracting material was presented in 200815
with devices that block anterior continuous curvilinear
capsulorrhexis, possibly posterior continuous curvilinear
capsulorrhexis, and prevent posterior capsule opacity. The
device was tested to produce 2.0 D to 3.0 D of accommoda-
tion in monkey eyes in 2014.13
In 2008, a concept IOL with a rotating focus mecha-
nism and a mechanical frame that can be operated by
ciliary muscle contraction was designed and a prototype
built.24 The proposed IOL was constructed of 2 optical
elements that could rotate around an axis that is parallel
to and decentered from the optical axis. Laboratory tests
demonstrated 8.0 D of accommodation. No further devel-
opment was published.
OPAL-A is a single-lens design introduced in 2010.
The one-piece IOL is hydrophilic acrylic with a 5.5-mm
diameter biconvex spherical optic and 4 flexible closed-
loop haptics with an overall diameter of 9.8 mm, intended
for implantation into the capsular bag. The IOL optic
is designed to shift forward on the flexible haptics with
accommodative effort.9 The OPAL-A was implanted in
22 eyes.9,68 Following 6 months, DCNVA was 0.34 ± 0.16,
objective amplitude of accommodation was 0.1 D ± 0.34 D,
subjective amplitude of accommodation was 2.5 D ± 0.62 D
with push-up test and 0.93 D ± 0.35 D with defocus curves.
The mean pilocarpine-stimulated forward IOL shift was
0.306 ± 0.161 mm by anterior segment OCT (Visante-1000)
and 0.270 ± 0.155 mm by partial coherence interferometry
(ACMaster; Carl Zeiss Meditec).
100  Chapter 10
The FluidVision IOL is composed of a hollow fluid-
filled hydrophobic acrylic optic and oversized hollow fluid-
filled haptics. The fluid in the optic and haptics is an index-
matched silicone oil that flows back and forth between the
haptics and optic to change the curvature, and hence the
power of the optic. FluidVision IOLs were examined upon
rabbits since 2013.19,20 They induced less posterior capsular
haze than a hydrophobic acrylic control IOL.
In 2015, McCafferty and Schwiegerling21 reported on
a lens prototype that could achieve acceptable accommoda-
tion with forces available in the ciliary body, by deforming
the interface between 2 materials with different refractive
indices.
Trulign
In 2015, the Trulign toric IOL emerged. It is an
astigmatism-correcting silicone multipiece IOL (model
AT-50T or AT-52T) and is a toric modification of the par-
ent Crystalens.8 The plate haptics are hinged adjacent to the
optic and have small-looped polyimide haptics. The toric
IOL is intended for placement in the capsular bag only. It
has a spherical front (anterior) surface and a toric back
(posterior) surface. Two marks on the peripheral anterior
optical surface aid in proper alignment of the IOL, indicat-
ing the flat axis of the toric IOL. The available spherical
equivalent powers range from +16.0 D to +27.0 D in 0.5-D
increments with cylindrical powers at the lens plane of 1.25
D, 2.0 D, and 2.75 D (estimated cylinder power at the cor-
neal plane 0.83 D, 1.33 D, and 1.83 D, respectively).
Recent Developments
A biomimetic accommodating IOL was proposed in
2016. The lens consists of a thin, deformable polymer shell
with a self-sealing valve to allow an optically clear fluid to
fill the lens. After filling, the lens takes the form of a natu-
ral crystalline lens, modeled after the natural 29-year-old
human lens. The new clear and accommodating lens can
function within the normal anatomy of the capsule, zon-
ules, and ciliary body.14 This concept was tested in human
cadaver eyes. As mentioned earlier, previously presbyopic
human cadaver eyes were able to accommodate between
2.0 D to 7.4 D after lens implantation.14
Also in 2016, AkkoLens International BV developed
a sliding-type IOL named the Lumina. It has 2 optical
elements that slide in a plane perpendicular to the opti-
cal axis, producing a continuous variable-focus lens. The
lens is positioned in the sulcus plane in front and on top
of the capsular bag. The lens movement is driven directly
by the ciliary muscle, without interference of the capsular
bag. This allows the eye to focus continuously from far
to near. When tested on cataract patients,23 it produced
1.27 D ± 0.76 D of objective accommodation at accommo-
dation stimuli of 4.0 D, as compared to a 0.07 D ± 0.1 D
for a monofocal control IOL. Uncorrected and corrected
distance visual acuities and contrast sensitivity were similar
over 12 months.
A new concept of voltage-controlled accommodating
IOL made of an ionic polymer metal composite actuator
was tested in vitro in 2016 to change focus.25 An actuator
was placed inside the eye and moved with applied voltage.
The lens attached to the actuator was deformed by its move-
ment to change the lens power. The results showed that this
system can accommodate a change of approximately 0.8 D
under an applied voltage of ±1.3 V.
CONCLUSION
As the quest for presbyopic correction continues,
accommodating IOLs seem to be the correct way to go.
This is the only method that enables the retina to capture
clear binocular images at varying distances, as all healthy
subjects were accustomed to expect during childhood and
early adulthood. Other methods require the use of spec-
tacles (multifocal glasses), the use of one eye at a time with
reduced depth perception (monovision), or reduced image
quality (multifocal IOLs, pinhole apertures).
The complex requirements of an accommodative lens
are the cause for the lack of success thus far. Most existing
and past lenses are able to produce a good or very good
image of a distance object with distance correction, but
all fail to deliver the premium benefit of 3.0 D or more of
objectively measured accommodation under accommoda-
tive stimulus.
Present designs of future lenses hold the promise to
deliver a true accommodative response. That holy grail of
surgical correction of presbyopia will by definition be an
accommodating pseudophakos. However, these designs are
described in a later chapter in this book.
REFERENCES
1. Pepose JS, Burke J, Qazi MA. Benefits and barriers of accommodat-
ing intraocular lenses. Curr Opin Ophthalmol. 2017;28(1):3-8.
2. Glasser A. Accommodation: mechanism and measurement.
Ophthalmol Clin North Am. 2006;19(1):1-12, v.
3. Ostrin L, Kasthurirangan S, Win-Hall D, Glasser A. Simultaneous
measurements of refraction and A-scan biometry during accommo-
dation in humans. Optom Vis Sci. 2006;83(9):657-665.
4. Legeais JM, Werner L, Werner L, Abenhaim A, Renard G.
Pseudoaccommodation: BioComFold versus a foldable silicone
intraocular lens. J Cataract Refract Surg. 1999;25(2):262-267.
5. Saiki M, Negishi K, Dogru M, Yamaguchi T, Tsubota K. Biconvex
posterior chamber accommodating intraocular lens implantation
after cataract surgery: long-term outcomes. J Cataract Refract Surg.
2010;36(4):603-608. doi:10.1016/j.jcrs.2009.11.008.
6. Cumming JS, Slade SG, Chayet A; AT-45 Study Group. Clinical
evaluation of the model AT-45 silicone accommodating intraocular
lens: results of feasibility and the initial phase of a Food and Drug
Administration clinical trial. Ophthalmology. 2001;108(11):2005-
2009; discussion 2010.
7. Sanders DR, Sanders ML. Visual performance results after Tetraflex
accommodating intraocular lens implantation. Ophthalmology.
2007;114(9):1679-1784.

8. Pepose JS, Hayashida J, Hovanesian J, et al. Safety and effective-
ness of a new toric presbyopia-correcting posterior chamber sili-
cone intraocular lens. J Cataract Refract Surg. 2015;41(2):295-305.
doi:10.1016/j.jcrs.2014.05.043.
9. Cleary G, Spalton DJ, Marshall J. Pilot study of new focus-
shift accommodating intraocular lens. J Cataract Refract Surg.
2010;36(5):762-770. doi:10.1016/j.jcrs.2009.11.025.
10. Leng L, Chen Q, Yuan Y, et al. Anterior segment biometry of the
accommodating intraocular lens and its relationship with the
amplitude of accommodation. Eye Contact Lens. 2017;43(2):123-129.
doi:10.1097/ICL.0000000000000248.
11. Hao X, Jeffery JL, Le TP, et al. High refractive index poly-
siloxane as injectable, in situ curable accommodating intraoc-
ular lens. Biomaterials. 2012;33(23):5659-5671. doi:10.1016/j.
biomaterials.2012.04.052.
12. Hao X, Jeffery JL, Wilkie JS, et al. Functionalised polysilox-
anes as injectable, in situ curable accommodating intraocu-
lar lenses. Biomaterials. 2010;31(32):8153-8163. doi:10.1016/j.
biomaterials.2010.07.065.
13. Nishi O, Nishi Y, Chang S, Nishi K. Accommodation ampli-
tudes after an accommodating intraocular lens refilling proce-
dure: in vivo update. J Cataract Refract Surg. 2014;40(2):295-305.
doi:10.1016/j.jcrs.2013.06.028.
14. DeBoer CM, Lee JK, Wheelan BP, et al. Biomimetic accom-
modating intraocular lens using a valved deformable liquid bal-
loon. IEEE Trans Biomed Eng. 2016;63(6):1129-1135. doi:10.1109/
TBME.2015.2484379.
15. Nishi O, Nishi K, Nishi Y, Chang S. Capsular bag refilling using
a new accommodating intraocular lens. J Cataract Refract Surg.
2008;34(2):302-309. doi:10.1016/j.jcrs.2007.09.042.
16. Alio JL, Ben-Nun J, Rodriguez-Prats JL, Plaza AB. Visual and
accommodative outcomes 1 year after implantation of an accommo-
dating intraocular lens based on a new concept. J Cataract Refract
Surg. 2009;35(10):1671-1678. doi:10.1016/j.jcrs.2009.04.043.
17. Ben-Nun J, Alio JL. Feasibility and development of a high-power
real accommodating intraocular lens. J Cataract Refract Surg.
2005;31(9):1802-1808.
18. Ben-Nun J. The NuLens accommodating intraocular lens.
Ophthalmol Clin North Am. 2006;19(1):129-134, vii.
19. Kohl JC, Werner L, Ford JR, et al. Long-term uveal and capsular bio-
compatibility of a new accommodating intraocular lens. J Cataract
Refract Surg. 2014;40(12):2113-2119. doi:10.1016/j.jcrs.2014.10.011.
20. Floyd AM, Werner L, Liu E, et al. Capsular bag opacification with
a new accommodating intraocular lens. J Cataract Refract Surg.
2013;39(9):1415-1420. doi:10.1016/j.jcrs.2013.01.051.
21. McCafferty SJ, Schwiegerling JT. Deformable surface accommodat-
ing intraocular lens: second generation prototype design methodol-
ogy and testing. Transl Vis Sci Technol. 2015;4(2):17.
22. Peng R, Li Y, Hu S, Wei M, Chen J. Intraocular lens based on
double-liquid variable-focus lens. Appl Opt. 2014;53(2):249-253.
doi:10.1364/AO.53.000249.
23. Alio JL, Simonov A, Plaza-Puche AB, et al. Visual outcomes and
accommodative response of the lumina accommodative intraocular
lens. Am J Ophthalmol. 2016;164:37-48. doi:10.1016/j.ajo.2016.01.006.
24. Hermans EA, Terwee TT, Koopmans SA, Dubbelman M, van
der Heijde RG, Heethaar RM. Development of a ciliary muscle-
driven accommodating intraocular lens. J Cataract Refract Surg.
2008;34(12):2133-2138. doi:10.1016/j.jcrs.2008.08.018.
25. Horiuchi T, Mihashi T, Fujikado T, Oshika T, Asaka K. Voltage-
controlled accommodating IOL system using an ion polymer
metal composite actuator. Opt Express. 2016;24(20):23280-23288.
doi:10.1364/OE.24.023280.
26. Simonov AN, Vdovin G, Loktev M. Liquid-crystal intraocular adap-
tive lens with wireless control. Opt Express. 2007;15(12):7468-7478.
27. Miller D. Accommodation in nature and principles for an accom-
modating intraocular lens. Ann Ophthalmol. 1985;17(9):540-541.
Accommodating Intraocular Lenses   101
28. Hardman Lea SJ, Rubinstein MP, Snead MP, Haworth SM.
Pseudophakic accommodation? A study of the stability of capsular
bag supported, one piece, rigid tripod, or soft flexible implants.
Br J Ophthalmol. 1990;74(1):22-25.
29. Hara T, Hara T, Yasuda A, Yamada Y. Accommodative intraocular
lens with spring action. Part 1. Design and placement in an excised
animal eye. Ophthalmic Surg. 1990;21(2):128-133.
30. Hara T, Hara T, Yasuda A, Mizumoto Y, Yamada Y. Accommodative
intraocular lens with spring action: part 2. Fixation in the living
rabbit. Ophthalmic Surg. 1992;23(9):632-635.
31. Cumming JS, Kammann J. Experience with an accommodating
IOL. J Cataract Refract Surg. 1996;22(8):1001.
32. Epstein RH, Liu ET, Werner L, Kohnen T, Kaproth OK, Mamalis N.
Capsulorhexis phimosis with anterior flexing of an accommodating
IOL: case report and histopathological analyses. J Cataract Refract
Surg. 2014;40(1):148-152. doi:10.1016/j.jcrs.2013.10.027.
33. Neuhann IM, Neuhann TF, Szurman P, Koerner S, Rohrbach JM,
Bartz-Schmidt KU. Clinicopathological correlation of 3 patterns
of calcification in a hydrophilic acrylic intraocular lens. J Cataract
Refract Surg. 2009;35(3):593-597. doi: 10.1016/j.jcrs.2008.08.048.
34. Kleinmann G, Werner L, Kaskaloglu M, Pandey SK, Neuhann IM,
Mamalis N. Postoperative opacification of the peripheral optic
region and haptics of a hydrophilic acrylic intraocular lens: case
report and clinicopathologic correlation. J Cataract Refract Surg.
2006;32(1):158-161.
35. Mastropasqua L, Toto L, Nubile M, Falconio G, Ballone E. Clinical
study of the 1CU accommodating intraocular lens. J Cataract
Refract Surg. 2003;29(7):1307-1312.
36. Kuchle M, Langenbucher A, Gusek-Schneider GC, Seitz B, Hanna
KD. First results of implantation of a new, potentially accommoda-
tive posterior chamber intraocular lens [in German]. Klin Monbl
Augenheilkd. 2001;218(9):603-608.
37. Hancox J, Spalton D, Heatley C, Jayaram H, Marshall J. Objective
measurement of intraocular lens movement and dioptric change
with a focus shift accommodating intraocular lens. J Cataract
Refract Surg. 2006;32(7):1098-1103.
38. Harman FE, Maling S, Kampougeris G, et al. Comparing the 1CU
accommodative, multifocal, and monofocal intraocular lenses: a
randomized trial. Ophthalmology. 2008;115(6):993-1001.e2.
39. Alessio G, L’Abbate M, Boscia F, La Tegola MG. Capsular block
syndrome after implantation of an accommodating intraocular
lens. J Cataract Refract Surg. 2008;34(4):703-706. doi:10.1016/j.
jcrs.2007.11.036.
40. Cumming JS, Colvard DM, Dell SJ, et al. Clinical evaluation of the
Crystalens AT-45 accommodating intraocular lens: results of the
U.S. Food and Drug Administration clinical trial. J Cataract Refract
Surg. 2006;32(5):812-825.
41. Alio JL, Pinero DP, Plaza-Puche AB. Visual outcomes and opti-
cal performance with a monofocal intraocular lens and a new-
generation single-optic accommodating intraocular lens. J Cataract
Refract Surg. 2010;36(10):1656-1664. doi:10.1016/j.jcrs.2010.04.040.
42. Hantera MM, Hamed AM, Fekry Y, Shoheib EA. Initial experience
with an accommodating intraocular lens: controlled prospective
study. J Cataract Refract Surg. 2010;36(7):1167-1172. doi:10.1016/j.
jcrs.2010.01.025.
43. Marcos S, Ortiz S, Perez-Merino P, Birkenfeld J, Duran S, Jimenez-
Alfaro I. Three-dimensional evaluation of accommodating intraoc-
ular lens shift and alignment in vivo. Ophthalmology. 2014;121(1):45-
55. doi:10.1016/j.ophtha.2013.06.025.
44. Dhital A, Spalton DJ, Gala KB. Comparison of near vision, intra-
ocular lens movement, and depth of focus with accommodat-
ing and monofocal intraocular lenses. J Cataract Refract Surg.
2013;39(12):1872-1878.
45. Zamora-Alejo KV, Moore SP, Parker DG, Ullrich K, Esterman
A, Goggin M. Objective accommodation measurement of the
Crystalens HD compared to monofocal intraocular lenses. J Refract
Surg. 2013;29(2):133-139. doi:10.3928/1081597X-20130117-09.
102  Chapter 10
46. Kim MJ, Zheleznyak L, Macrae S, Tchah H, Yoon G. Objective
evaluation of through-focus optical performance of presbyopia-cor-
recting intraocular lenses using an optical bench system. J Cataract
Refract Surg. 2011;37(7):1305-1312. doi:10.1016/j.jcrs.2011.03.033.
47. Jardim D, Soloway B, Starr C. Asymmetric vault of an accommodat-
ing intraocular lens. J Cataract Refract Surg. 2006;32(2):347-350.
48. Yuen L, Trattler W, Boxer Wachler BS. Two cases of Z syndrome
with the Crystalens after uneventful cataract surgery. J Cataract
Refract Surg. 2008;34(11):1986-1989. doi:10.1016/j.jcrs.2008.05.061.
49. Tomas-Juan J, Murueta-Goyena Larranaga A. Axial movement of
the dual-optic accommodating intraocular lens for the correction
of the presbyopia: optical performance and clinical outcomes.
J Optom. 2015;8(2):67-76. doi:10.1016/j.optom.2014.06.004.
50. Doane JF, Jackson RT. Accommodative intraocular lenses: con-
siderations on use, function and design. Curr Opin Ophthalmol.
2007;18(4):318-324.
51. McLeod SD, Portney V, Ting A. A dual optic accommodating fold-
able intraocular lens. Br J Ophthalmol. 2003;87(9):1083-1085.
52. Werner L, Pandey SK, Izak AM, et al. Capsular bag opacification
after experimental implantation of a new accommodating intraocu-
lar lens in rabbit eyes. J Cataract Refract Surg. 2004;30(5):1114-1123.
53. McLeod SD. Optical principles, biomechanics, and initial clinical
performance of a dual-optic accommodating intraocular lens (an
American Ophthalmological Society thesis). Trans Am Ophthalmol
Soc. 2006;104:437-452.
54. Ossma IL, Galvis A, Vargas LG, Trager MJ, Vagefi MR, McLeod SD.
Synchrony dual-optic accommodating intraocular lens. Part 2: pilot
clinical evaluation. J Cataract Refract Surg. 2007;33(1):47-52.
55. Marques EF, Castanheira-Dinis A. Clinical performance of a
new aspheric dual-optic accommodating intraocular lens. Clin
Ophthalmol. 2014;8:2289-2295. doi:10.2147/OPTH.S72804.
56. Bohorquez V, Alarcon R. Long-term reading performance in
patients with bilateral dual-optic accommodating intraocular lens-
es. J Cataract Refract Surg. 2010;36(11):1880-1886. doi:10.1016/j.
jcrs.2010.06.061.
57. Ehmer A, Mannsfeld A, Auffarth GU, Holzer MP. Dynamic stimu-
lation of accommodation. J Cataract Refract Surg. 2008;34(12):2024-
2029. doi:10.1016/j.jcrs.2008.07.034.
58. Alio JL, Plaza-Puche AB, Montalban R, Ortega P. Near visual out-
comes with single-optic and dual-optic accommodating intraocular
lenses. J Cataract Refract Surg. 2012;38(9):1568-1575. doi:10.1016/j.
jcrs.2012.05.027.
59. Marques EF, Ferreira TB, Castanheira-Dinis A. Visualization of the
macula during elective pars plana vitrectomy in the presence of a
dual-optic accommodating intraocular lens. J Cataract Refract Surg.
2014;40(5):836-839. doi:10.1016/j.jcrs.2014.03.005.
60. Wolffsohn JS, Naroo SA, Motwani NK, et al. Subjective and objec-
tive performance of the Lenstec KH-3500 “accommodative” intra-
ocular lens. Br J Ophthalmol. 2006;90(6):693-696.
61. Sanders DR, Sanders ML; Tetraflex Presbyopic IOL Study Group.
US FDA clinical trial of the Tetraflex potentially accommodat-
ing IOL: comparison to concurrent age-matched monofocal con-
trols. J Refract Surg. 2010;26(10):723-730. doi:10.3928/108159
7X-20091209-06.
62. Dong Z, Wang NL, Li JH. Vision, subjective accommodation and
lens mobility after TetraFlex accommodative intraocular lens
implantation. Chin Med J (Engl). 2010;123(16):2221-2224.
63. Wolffsohn JS, Davies LN, Gupta N, et al. Mechanism of action
of the tetraflex accommodative intraocular lens. J Refract Surg.
2010;26(11):858-862. doi:10.3928/1081597X-20100114-04.
64. Li J, Chen Q, Lin Z, Leng L, Huang F, Chen D. The predictability of pre-
operative pilocarpine-induced lens shift on the outcomes of accom-
modating intraocular lenses implanted in senile cataract patients.
J Ophthalmol. 2016;2016:6127130. doi:10.1155/2016/6127130.
65. Lan J, Huang YS, Dai YH, Wu XM, Sun JJ, Xie LX. Visual perfor-
mance with accommodating and multifocal intraocular lenses.
Int J Ophthalmol. 2017;10(2):235-240. doi:10.18240/ijo.2017.02.09.
66. Kramer GD, Werner L, Neuhann T, Tetz M, Mamalis N. Anterior
haptic flexing and in-the-bag subluxation of an accommodating
intraocular lens due to excessive capsular bag contraction. J Cataract
Refract Surg. 2015;41(9):2010-2013. doi:10.1016/j.jcrs.2015.08.009.
67. Sadoughi MM, Einollahi B, Roshandel D, Sarimohammadli M,
Feizi S. Visual and refractive outcomes of phacoemulsification
with implantation of accommodating versus standard monofo-
cal intraocular lenses. J Ophthalmic Vis Res. 2015;10(4):370-374.
doi:10.4103/2008-322X.176896.
68. Cleary G, Spalton DJ, Marshall J. Anterior chamber depth mea-
surements in eyes with an accommodating intraocular lens: agree-
ment between partial coherence interferometry and optical coher-
ence tomography. J Cataract Refract Surg. 2010;36(5):790-798.
doi:10.1016/j.jcrs.2009.11.028.

Extended Depth of
Focus Intraocular Lenses
Robert M. Kershner, MD, MS, FACS
Sir Harold Ridley, acting on the suggestion of one of his
registrars (residents), Steve Parry, invented and implanted
the first intraocular lens (IOL) in England on November 29,
1949. Since that time, cataract surgery has experienced an
exponential worldwide growth spawning a plethora of new
surgical technologies and devices. The majority of IOLs
implanted worldwide have been monofocal. Monofocal
IOLs have a single point of focus and are usually selected
to provide the best distance vision (Figure 11-1). Multifocal
IOLs utilize diffractive optics that splits light from an image
into 3 separate focal points at distance, intermediate, and
near. Accommodating IOLs work by responding to the
movement in the ciliary body as a response to near accom-
modation.1 These IOLs are dependent upon lens capsular
fluidity, a state that can be difficult to achieve and maintain
following cataract extraction with resultant capsular fibro-
sis.2 Indeed, studies have shown that the actual amount
of accommodative add provided is less than 1.25 diopters
(D).3 The ideal accommodating IOL therefore, would be
one that, mimicking the youthful crystalline lens, would
alter its focal distance in response to near visual needs.4
One of the most significant advances in cataract
surgical technology has been the modification of Ridley’s
original spherical biconvex IOL into a lens that can pro-
vide not only clear uncorrected distance vision but added
vision at near as well. One of the newer innovations in the
surgical correction of presbyopia is the concept of extended
- 103 -
11
depth of focus (EDOF), or extended range of vision, IOLs
(see Figure 11-1). The strategy behind this approach is
quite simple. The EDOF IOL uses elongated optics to
increase the depth of field. There are several different
approaches to this emerging technology. Manufacturers
who are bringing these EDOF IOLs to market aim to reduce
or eliminate the known optical side effects of monofocal
and accommodating IOLs while creating the long-sought-
after clear, uncorrected near vision that patients demand.
According to the American Academy of Ophthalmology
Task Force Consensus Statement,5 the minimum perfor-
mance criteria to categorize any device as an EDOF IOL is
as follows:
1. The EDOF IOL group should demonstrate compa-
rable monocular mean corrected distance visual
acuity when compared to monofocal controls.
2. The monocular depth of focus curves for the
EDOF IOL should be at least 0.5 D greater than
the depth of focus for the monofocal IOL controls
at 0.2 logMAR (20/32 Snellen).
3. The mean (logMAR) monocular distance-cor-
rected intermediate visual acuity (DCIVA) needs
to be tested under photopic conditions at 66 cm
at 6 months and should demonstrate statistical
superiority over the control (one-sided test using
significance of .025).
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 103-109).
© 2019 SLACK Incorporated.
104  Chapter 11
Figure 11-1. (Top) Laser projection through a monofocal IOL
demonstrates a single point of focus. (Middle) Laser projection through
a multifocal IOL demonstrates 2 distinct points of focus. (Bottom) Laser
projection through an EDOF IOL demonstrates an increased range in
the point of focus. (Reprinted with permission from Johnson & Johnson
Vision.)
4. At least 50% of eyes should achieve monocular
DCIVA of 0.2 logMAR (20/32 Snellen) or better
at 66 cm.
5. American National Standards Institute/
International Organization for Standardization–
compliant visual acuity charts should have a rec-
ommended nominal luminance of 85 cd/m2 (80 to
100 cd/m2).
6. A monocular defocus curve should be obtained
by using the corrected distance refraction and
measuring the visual acuity between +1.5 D and
-2.5 D in 0.5-D defocus steps, except in the region
from +0.5 D to -0.5 D, in which case it should be
in 0.25-D steps.
7. The defocus curve data should be stratified accord-
ing to the patients’ pupil size and axial length.
8. The mesopic contrast sensitivity function should
be performed at 1.5, 3.0, 6.0, and 12.0 spatial fre-
quencies (cycles/degree).
TECNIS SYMFONY
INTRAOCULAR LENS
The average human cornea has a net positive spherical
aberration. In youthful eyes, the crystalline lens delivers an
overall negative spherical aberration to the optical system
of the eye, effectively neutralizing it (Figure 11-2A).6 As we
age, the lens becomes thicker, resulting in an increased
positive spherical aberration, which leads to blurred vision
and reduced contrast sensitivity (Figure 11-2B). Most spher-
ical IOLs have a net positive aberration, which makes this
worse. In early 2000, Pharmacia (now Johnson & Johnson
Vision) introduced the first Food and Drug Administration
(FDA)–approved biconvex, wavefront-designed anterior
aspheric surface IOL, the TECNIS, to correct this optical
aberration and reduce the image degradation seen with
spherical IOLs (Figure 11-2C).7-13 Studies have shown that
the IOL effectively decreased spherical aberration and glare
and improved functional vision, contrast sensitivity, and
night driving (Figure 11-3).14-19
The refractive index of the eye varies depending upon
the wavelength of light that is being focused. The vis-
ible wavelengths of light between violet (400 nm) and red
(700 nm) are each bent differently by the human cornea and
lens with the longer wavelengths of light being bent more
than the shorter wavelengths. As a result, the various colors
are focused at different focal points along the optical axis,
known as longitudinal chromatic aberration (Figure 11-4A).
Chromatic aberration degrades image quality, causing blur-
ring and color fringing at edges of an image (Figures 11-4B
and 11-4C). Colors that are out of focus can cause blur and
reduction in contrast sensitivity.20-25 The average human
eye has approximately 2.0 D of chromatic aberration.
Pseudophakia adds to this chromatic aberration.
In an effort to correct 2 of the inherent problems of
presbyopic correcting IOLs, namely, chromatic and spheri-
cal aberration, the technology of the TECNIS aspheric
anterior surface IOL was combined with a posterior optic
achromatic diffractive surface with an echelette design
(Figure 11-5). The TECNIS Symfony IOL (Johnson &
Johnson Vision), the first in its class, received the CE mark,
and was granted FDA approval for use in the United States
on July 15, 2016. The IOL contains an ultraviolet-absorbing
chromophore with an overall diameter of 13.0 mm, an optic
of 6.0 mm, and powers from +5.0 D to +34.0 D and includes
a toric version, indicated for adult cataract patients with less
than 1.0 D of pre-existing corneal astigmatism. These IOLs
provide 14% to 35% improved image contrast as a result
of chromatic aberration reduction and full correction of
spherical aberration.
How does a single optic IOL accomplish this degree
of optical correction? While the anterior optical surface is
neutralizing spherical aberration, the posterior achromatic
diffractive surface takes a single focal point and elongates it.
This proprietary diffractive echelette design, a novel diffrac-
tion grating designed to reflect light, creates a step structure
that elongates the focus of the eye, increasing the depth of
field and extending its range of vision (Figure 11-6). The
extended range of vision afforded by this technology pre-
cludes the image blur associated with multifocal optics.26,27
 Extended Depth of Focus Intraocular Lenses   105

A B

Figure 11-2. (A) The positive spherical aberration of

C the normal cornea is neutralized by the net negative
spherical aberration of the youthful lens, resulting in
excellent contrast sensitivity for all images. (B) The
positive spherical aberration of the normal cornea is
added to the positive spherical aberration of the aging
lens, resulting in decreased contrast sensitivity. (C) The
positive spherical aberration of the normal cornea is
neutralized by the negative spherical aberration of the
aspheric IOL, resulting in increased contrast sensitivity
for all images.

A B

Figure 11-3. (A) Conventional spherical IOLs resulted in

C decreased contrast sensitivity, demonstrated by the
washed-out appearance in this photo. (B) Conventional
spherical IOLs increased glare, demonstrated in this photo.
(C) Aspheric IOLs improved contrast sensitivity and reduced
glare, demonstrated by this sharp image.
106  Chapter 11

A B

C
Figure 11-4. (A) IOLs uncorrected for chromatic
aberration. (B) IOLs uncorrected for chromatic
aberration result in fringing around images. (C) IOLs
corrected for chromatic aberration.

Figure 11-5. (A) The echelette diffractive gradient design on

the posterior optic reduces chromatic aberration. (B) TECNIS A B
Symfony Toric IOL in a patient referred for complications.
(Reprinted with permission from Arun Gulani, MD.) (C)
Proprietary echelette design of the TECNIS Symfony Toric IOL.
(Reprinted with permission from Johnson & Johnson Vision.)

C

A B
Figure 11-6. (A) Through-focus iTrace (Tracey Technologies) depth of focused light in a conventional phakic IOL with a depth of
focus of 0.71 D. (B) Through-focus depth of focused light in an EDOF phakic IOL with a depth of focus of 1.22 D. (Reprinted with
permission from Tracy Schroeder Swartz, OD, MS, FAAO, Dipl ABO.)
In an Abbott Medical Optics pilot study comparing
bilaterally implanted TECNIS Symfony IOLs in 31 patients
with bilateral monofocal TECNIS implants, Symfony
patients achieved a mean visual acuity of 20/20 or better
throughout 1.5 D of defocus. However, mean distance-
corrected near visual acuity was only 20/30. The level
of dysphotopsias was substantially reduced compared to
multifocal IOLs, resulting in superior patient satisfaction.28
In a much larger study, 411 patients had bilateral
implantation of the extended range of vision IOLs, with the
goal of monovision in one group and emmetropia in the
other. Significantly better uncorrected vision was found in
the monovision group, with only 14.4% of eyes requiring
reading spectacles. The incidence of dysphotopsias was low,
with more than 90% of the patients reporting no or mild
halos, glare, starbursts, or other photic phenomena.29
IC-8 SMALL-APERTURE
INTRAOCULAR LENS
The IC-8 small-aperture IOL by AcuFocus, Inc has
received the CE mark in Europe. Based on the KAMRA
corneal inlay technology (CorneaGen), the IC-8 lens fea-
tures an embedded opaque annular mask that blocks unfo-
cused peripheral light rays while allowing paraxial light
rays through its central aperture (Figure 11-7). According
to the manufacturer, the small-aperture design creates an
extended, continuous range of functional vision across all
distances. The optics are based upon the pinhole effect, near
vision is improved without sacrificing distance vision by
allowing the central unfocused ray of light to pass directly
to the fovea. The IOL decreases contrast and associated
glare, but with only 2 points of focus, this effect should not
be as considerable as with conventional multifocal IOLs.
Results from monocular implantation of the IC-8
small-aperture IOL demonstrate improved range of vision
at 12 months, achieving 20/20 acuity at both intermediate
Extended Depth of Focus Intraocular Lenses   107
and distance, with a mean near acuity of J1 (Jaeger).
Symptoms of glare and decreased contrast reported were
similar between the IC-8 eye and the fellow eye implanted
with a standard monofocal IOL.
XTRAFOCUS PINHOLE
INTRAOCULAR LENS
The German IOL manufacturer, Morcher GmbH, along
with Dr. Claudio Trindade, designed a pinhole optics IOL.
Utilizing a thin, foldable, hydrophobic acrylic IOL without
refractive power, the XtraFocus design performs similarly
to the AcuFocus, Inc pinhole IOL described earlier. This
IOL design is implanted into the sulcus of the pseudopha-
kic eye. The pinhole optics effect reduces the amount of
the incident light that falls upon the retina, extending the
depth of focus, to improve intermediate and near vision.
The manufacturer lists additional possible indications for
the use of the IOL in the treatment of irregular astigmatism
and corneal irregularities as a result of refractive surgery,
keratoconus, pellucid marginal degeneration, or perforat-
ing corneal trauma.
WIOL-CF POLYFOCAL
INTRAOCULAR LENS
Medicem’s WIOL-CF is the first of its kind in design:
a unique bioanalogic polyfocal IOL. Produced from a
proprietary hydrogel, the IOL has been designed to mimic
the properties of the natural crystalline lens. According to
the manufacturer, this IOL enables polyfocal accommoda-
tion within a continuous range from near to distant focus.
Multicenter studies in Europe and Korea have demon-
strated excellent visual acuity for distance and intermedi-
ate vision, with contrast sensitivity exceeding population
108  Chapter 11
Figure 11-7. Illustration of the IC-8 small-aperture IOL by
AcuFocus, Inc. ( Reprinted with permission from AcuFocus, Inc.)
norms under all light conditions. The studies reported
20/20 uncorrected distance visual acuity, with an average
uncorrected intermediate visual acuity of J1+ and mean
uncorrected near visual acuity of J2.6. Patient satisfaction
was recorded as high, with only 4% of the patients report-
ing symptoms of halos and glare. Ninety-three percent of
patients reported near spectacle independence and 89%
were satisfied with their outcome.30 Clinical studies indi-
cate that the lens maintains its transparency for up to 7
years following implantation. Whether or not this IOL will
gain FDA approval has not yet been determined.
AT LARA
The AT LARA (Carl Zeiss Meditec) is an aberration-
neutral, aspheric EDOF IOL not currently available in the
United States (Figure 11-8). Advanced chromatic correction
boasts optimized contrast sensitivity according to the man-
ufacturer, but further research and comparative studies
are required. The diffractive edge design uses proprietary
Smooth Microphase technology (Carl Zeiss Meditec), shal-
lower diffraction angles minimizing the amount of light
scatter.
CONCLUSION
We currently are only scratching the surface of the
limitless possibilities available to solve this perennial,
perplexing, and persistent quest for the correction of pres-
byopia with an implantable device. Although the TECNIS
Symfony IOL is the only EDOF IOL presently available
to surgeons for use in the United States, the variations in
design and optics that could be tapped to achieve this goal
is robust.
Figure 11-8. The AT LARA is an EDOF IOL boasting Smooth Microphase
technology to reduce light scatter. This lens is not available for sale in
the United States. (Reprinted with permission from Carl Zeiss Meditec.)
REFERENCES
1. Dhital A, Spalton DJ, Gala KB. Comparison of near vision, intra-
ocular lens movement, and depth of focus with accommodat-
ing and monofocal intraocular lenses. J Cataract Refract Surg.
2013;39(12):1872-1878.
2. Alio JL, Vega-Estrada A. Accommodative intraocular lenses: where
are we and where we are going. Eye and Vision. June 2017;(4):16.
3. Yamamoto S, Adachi-Usami E. Apparent accommodation in pseu-
dophakic eyes as measured with visually evoked potentials. Invest
Ophthalmol Vis Sci. 1992;33(2):443-446.
4. Kim HJ, Seo JW, Shin SJ, Chung SK. Visual outcome and stability
of hydrogel full-optics accommodative intraocular lens. Korean
5.
Ophthalmol Soc. 2011;52(12):1448-1454.
Masket S, Rorer E, Stark W, et al. Special report: the American
Academy of Ophthalmology Task Force consensus state-
ment on adverse events with intraocular lenses. Ophthalmology.
2017;124(1):142-144.
6. Artal P, Alcon E, Villegas E. Spherical aberration in young subjects
with high visual acuity. Paper presented at: European Society of
Cataract & Refractive Surgeons; 2006; Dublin, Ireland.
7. Kershner, RM. Can an aspheric IOL improve visual performance.
Cataract and Refractive Surgery Today. June 2003:1-2.
8. Kershner RM. Improved functional vision with modified prolate
IOL. Clin Surg Ophthalmol. 2005;Mar.
9. Kershner RM. Retinal image contrast and functional visual per-
formance with aspheric, silicone, and acrylic intraocular lenses.
Prospective evaluation. J Cataract Refract Surg. 2003;29(9):1684-1694.
10. Kershner RM. Tecnis IOL adapts well to injector system. Ocular
11.
Surgery News. 2004;22(21):4, 5-53.
Kershner RM, Packer M, Fine IH, Hoffman RS. Tecnis innovator-
perspectives in lens and IOL surgery. EyeWorld. 2003;Jul:39-42.
12. Kershner RM. Next generation IOLs: the Tecnis Multifocal IOL.
Cataract and Refractive Surgery Today. 2005;3(5):74-75.
13. Kershner RM. New technology IOLs. Clin Surg Ophthalmol.
2005;Mar.
14. Piers PA, Manzanera S, Prieto PM, et al. Use of adaptive optics
to determine the optimal ocular spherical aberration. J Cataract
Refract Surg. 2007;33(10):1721-1726.
15. Mester U, Dillinger P, Anterist N. Impact of a modified optic design
on visual function: clinical comparative study. J Cataract Refract
Surg. 2003;29(4):652-660.
16. Bellucci R, Scialdone A, Buratto L, et al. Visual acuity and contrast
sensitivity comparison between TECNIS and AcrySof SA60AT
intraocular lenses: a multicenter randomized study. J Cataract
Refract Surg. 2005;31(4):712-717.

17. Kennis H, Huygens M, Callebaut F. Comparing the contrast sensi-
tivity of a modified prolate anterior surface IOL and of two spherical
IOLs. Bull Soc Belge Ophtalmol. 2004;294:49-58.
18. Packer M, Fine IH, Hoffman RS, Piers PA. Prospective random-
ized trial of an anterior surface modified prolate intraocular lens.
J Refract Surg. 2002;18(6):692-696.
19. Martinez Palmer A, Palacin Miranda B, Castilla Cespedes M, et
al. [Spherical aberration influence in visual function after cataract
surgery: prospective randomized trial.] Arch Soc Esp Oftalmol.
2005;80(2):71-78.
20. Thibos LN, Ye M, Zhang X, Bradley A. The chromatic eye: a new
reduced-eye model of ocular chromatic aberration in humans. Appl
Opt. 1992;31(19):3594-3600.
21. Siedlecki D, Jozwik A, Zaja M, Hill-Bator A, Turno-Krecicka A.
In vivo longitudinal chromatic aberration of pseudophakic eyes.
Optom Vis Sci. 2014;91(2):240-246.
22. Perez-Merino P, Dorronsoro C, Llorente L, Duran S, Jimenez- Alfaro
I, Marcos S. In vivo chromatic aberration in eyes implanted with
intraocular lenses. Invest Ophthalmol Vis Sci. 2013;54(4):2654-2661.
23. Siedlecki D, Ginis HS. On the longitudinal chromatic aberration of
the intraocular lenses. Optom Vis Sci. 2007;84(10):984-989.
24. Zhao H, Mainster MA. The effect of chromatic dispersion on pseudo-
phakic optical performance. Br J Ophthalmol. 2007;91(9):1225-1229.
Extended Depth of Focus Intraocular Lenses   109
25. Negishi K, Ohnuma K, Hirayama N, Noda T; Policy-Based Medical
Services Network Study Group for Intraocular Lens and Refractive
Surgery. Effect of chromatic aberration on contrast sensitivity in
pseudophakic eyes. Arch Ophthalmol. 2001;119(8):1154-1158.
26. Kent C, Kershner RM, Mackool R, Wallace RB, Crotty,
RT. The art of implanting multifocal lenses. Rev Ophthalmol.
2015;XXII(1):24-31,38.
27. Pedrotti E, Bruni E, Bonacci E, Badalamenti R, Mastropasqua R,
Marchini G. Comparative analysis of the clinical outcomes with
a monofocal and an extended range of vision intraocular lens.
J Refract Surg. 2016;32(7):436-442.
28. Sadoughi MM, Einollahi B, Roshandel D, Sarimohammadli M,
Feizi S. Visual and refractive outcomes of phacoemulsification with
implantation of accommodating versus standard monofocal intra-
ocular lenses. J Ophthalmic Vis Res. 2015;10(4):370-374.
29. Cochener B. Clinical outcomes of a new extended range of vision
intraocular lens: International Multicenter Concerto Study. J Oph
Vis Res. 2016;42(9):1268-1275.
30. Studeny P, Krizova D, Urminsky J. Clinical experience with
the WIOL-CF accommodative bioanalogic intraocular lens:
Czech national observational registry. Eur J Ophthalmol.
2016;26(3):230-235.

Complex Intraocular Lens Cases
Arun C. Gulani, MD, MS and Tracy Schroeder Swartz, OD, MS, FAAO, Dipl ABO
Unhappy premium intraocular lens (IOL) patients may
result from problems with surgical candidacy and dissatis-
faction with surgical outcome. Dissatisfaction may occur
even when the surgery was performed perfectly. Often, the
surgeon did not meet patient expectations, the visual qual-
ity is less than acceptable, or the surgeon failed to address
the patient’s complaints.
Detailed preoperative evaluations are required to ensure
there are no contraindications for presbyopia surgery. It
is best to identify contraindications prior to surgery, and
explain why the patient is not a candidate for the desired
lens, rather than addressing a complaint after implanta-
tion. Patients with problematic expectations or previous
refractive surgery are particularly difficult to satisfy. When
evaluating a patient with surgical complications, it may be
beneficial to consider a systematic approach, described in
Table 12-1. Complications may be related to anatomy, lens-
based problems, and patient symptoms and expectations.
ANATOMICAL COMPLICATIONS
Anatomical complications include structural changes
to anatomy, such as corneal, iris, or vitreoretinal tissue
problems. Ocular inflammation should be corrected prior
- 111 -
12
to surgery, because any ocular surgery can increase both
anterior and posterior segment inflammation. Meibomian
gland dysfunction, blepharitis, conjunctival chalasis, aller-
gic conjunctivitis, keratoconjunctivitis sicca, vernal con-
junctivitis, demodex infection, lagophthalmus, trichiasis,
and any other anterior segment abnormalities should be
addressed with the patient prior to the procedure. Should
these issues increase after surgery, the patient will typically
feel the intraocular surgery caused the problem.
Case 1
A 57-year-old male presented following femtosecond
laser–assisted cataract surgery with a TECNIS multifocal
implant (Johnson & Johnson Vision). He reported his vision
had been steadily decreasing in the weeks after surgery,
with increasing ocular discomfort. He reported that by the
end of the day, his vision left him unable to drive home
from work comfortably. Unaided vision was 20/30 OS, and
improved to 20/25 with -1.25 +1.50 x 160. The endpoint
was soft and varied with blinking. He was unable to dis-
cern small changes in refraction. Slit lamp exam revealed
significant neovascularization of the lid margins, frothing,
and minimal expression (3/15 LL OU) of the meibomian
glands. The tear film was thickened, and osmolarity was
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 111-121).
© 2019 SLACK Incorporated.
112  Chapter 12

TABLE 12-1
GULANI PRESBYOPIA CATARACT COMPLICATION ANALYSIS
Surgery-related Anatomical damage (corneal, iris, etc); inflammation; optical pathway (pupil, lens centration, etc)
complications
IOL-based problems IOL power, IOL optics in relation with corneal optics, IOL defects (broken/cracked/subluxated)
Patient symptomatology Dysphotopsia (IOL capture), glare, psychological issues

Figure 12-1. Central astigmatism reducing the reading effect of a TECNIS implant and reducing best-corrected vision to 20/25.
Treatment improved both unaided and best-corrected vision.

Figure 12-2. Epithelial basement membrane dystrophy Figure 12-3. Salzmann’s degeneration may cause visual
may complicate IOL calculations due to an irregular significant irregular astigmatism.
corneal surface.

Corneal structural issues are best identified and treated

measured to be 350 mOsm/L. After using a lipid-containing
tear 4 times a day and 50 mg doxycycline orally daily for 30
days, the central astigmatism improved. Best correction of
20/20 was achieved with -0.75 +0.75 x 155. He reported he
was more comfortable driving at night and declined night
vision driving glasses (Figure 12-1).
prior to referral for phacoemulsification. Examples include
epithelial basement membrane dystrophy (Figure 12-2),
keratitis, Salzmann’s degeneration (Figure 12-3), Fuchs’ dys-
trophy, and keratoconus. Since the IOL power is calculated
based upon the keratometry measurements, the corneal
irregularity should be addressed prior to IOL calculation.

Figure 12-4. Irregular astigmatism manifests as a difference in refractive keratometry values compared to simulated keratometry
values. This patient suffered from residual refraction due to irregular astigmatism complicating IOL calculation. Note the irregular
corneal cylinder.
Irregular astigmatism makes corneal power measurement
inaccurate and results in residual refractive error. This is
most commonly a problem in patients with a history of
refractive surgery or keratoconus but is also a problem in
patients with corneal degenerations or dystrophies. Corneal
topography should be performed to assess the regularity of
the corneal surface and need for a toric IOL. If the topog-
rapher can compare refractive keratometry readings with
simulated keratometry readings, this task is easy. If there is
a 1.0-diopter (D) difference in the refractive and simulated
keratometry values, the risk of residual refractive errors
increases (Figure 12-4).
Pupil abnormalities, such as iris atrophy, large periph-
eral iridotomies, or Adie’s pupil, may cause problems with
multifocal IOLs. Abnormalities in pupil shape after surgery
may result in cases where miotic pupils were mechanically
opened during phacoemulsification using iris hooks or a
Malyugin ring (Microsurgical Technology). Increased pupil
size may result in increased glare and halos.1
Case 2
A 58-year-old female presented for a second opinion.
She had a history of radial keratotomy (RK) several years
prior, followed by a TECNIS Symfony IOL (Johnson &
Johnson Vision) implantation. She complained of poor
vision, night glare, and halos. Unaided, she was 20/25 at
distance and 20/60 at near. The pupil in the right eye was
Complex Intraocular Lens Cases   113
sluggish, distorted, and dilated. Both angle kappa and
alpha were elevated (0.832 mm and 0.603 mm; Figure 12-5).
Because the pupil was permanently dilated due to surgical
trauma, topical miotics were attempted to determine if her
symptoms would improve. Thankfully, she was pleased with
the effect of 0.50% pilocarpine and was able to read 20/30
with pharmacological treatment.
Ocular alignment should be addressed preoperatively
to ensure success using a premium lens. Clinical assess-
ment of angle kappa and alpha should be performed prior
to discussion of IOL options. Angle kappa is the difference
between the visual axis and center of the pupil. This is par-
ticularly important in keratorefractive surgery for hyper-
opes or in presbyopic treatments (Figure 12-6).
Angle alpha is the angle between the visual axis and
the center of the limbus. The center of the limbus is thought
to represent the center of the lens capsule, and is used to
predict where the IOL will be positioned after implanta-
tion. Current IOL technology employs haptics that center
the IOL in the capsular bag. If the IOL within the bag is
not aligned with the visual axis, the patient will not look
through the center of the IOL. This will induce higher order
aberrations and negatively affect visual function.2 Toric
IOLs also require proper alignment but may be more for-
giving then a multifocal IOL. Decentration of toric lenses
may induce astigmatism or reduce the power of the cylinder
resulting in residual refractive error.
114  Chapter 12

Figure 12-5. Pupil abnormalities, such as an irregular-shaped pupil following the use of iris hooks
during cataract surgery can have deleterious effects on vision with a multifocal IOL.

Figure 12-6. Angle kappa is the difference between the visual axis and center of the pupil. Angle alpha
is the angle between the visual axis and the center of the limbus. The center of the limbus is thought to
predict where the IOL will be positioned after implantation.

In addition to optical alignment, position of the IOL
in the bag is related to the capsulorrhexis. A well-centered,
properly sized capsulorrhexis is important for multifocal
IOL function.3,4 Decentered capsulotomy may be problem-
atic in multifocal IOL patients if the IOL fails to center in
the bag.
Multifocal lenses have a lower threshold for YAG
(yttrium-aluminum-garnet) capsulotomy, but must be
handled with careful consideration since performing the
YAG makes exchange extremely difficult. If the patient
was initially happy, and then becomes unhappy with visual
function due to posterior capsular haze, the YAG will most
likely help. If the patient was never happy with the vision
following implantation, YAG may be ill-advised. Capsular
haze may alter the refractive error due to fibrosis or distort
the vision (Figure 12-7). When performing a YAG, careful
application to remove all strands beyond the optical zone
and avoid hitting the IOL is recommended.
The posterior segment must also be evaluated in
patients with visual complaints. Retinal abnormalities
should be identified prior to multifocal implants since
reduced macular function will impact the effectiveness of
the IOL. Macular optical coherence tomography (OCT)
scans are typically performed preoperatively for this reason
(Figure 12-8). Three-dimensional, cube analysis is preferred
to a macular scan using slices to ensure comprehensive
evaluation. Early holes, asymmetric foveal depressions,
epiretinal membranes, and slight retinal pigment epithe-
lium disruptions or detachments may be an issue in a 20/20
eye with a multifocal lens.
 Complex Intraocular Lens Cases   115

A B

C D

Figure 12-7. (A) A TECNIS Symfony lens 1 day status post-YAG procedure. The strands continue to reduce the vision
subjectively. (B) Crystalens (Bausch + Lomb) with a poorly performed YAG. The procedure failed to improve the
subjective vision. (C) Crystalens with an improperly performed YAG procedure. (D) Strands on a ReSTOR (Alcon
Laboratories, Inc) IOL in a symptomatic patient.

Figure 12-8. An OCT in a 20/20 eye revealed an epiretinal membrane.

116  Chapter 12
Figure 12-9. Retinal OCT demonstrating mild vitreomacular traction with distortion of the macular depression,
causing subjective reading complaints.
Case 3
A 67-year-old female presented with 20/20 vision at dis-
tance but reduced function at near with a TECNIS Symfony
IOL. Slit lamp revealed mild ocular surface disease but not
enough to warrant a reading complaint. OCT scanning of
the macula revealed vitreomacular traction with loss of the
foveal depression (Figure 12-9).
INTRAOCULAR
LENS–BASED COMPLICATIONS
Defective IOL optics, and broken or damaged haptics,
are rare, but typically warrant exchange to restore visual
quality.
Case 4
A patient presented reporting fluctuating vision,
with glare that changed location. Upon dilation, a broken
haptic was noted. The lens was successfully exchanged
(Figure 12-10).
Surgical factors include variability in the effective lens
position, IOL decentration and tilt, subluxation, and surgi-
cally induced astigmatism. All of these problems contribute
to residual refractive error.5,6 This is also an issue with pre-
mium IOL patients, who select a premium lens procedure
to be spectacle independent. When residual refractive error
requires spectacle correction, the patient will be unhappy.
Correction of refractive error may be performed using
keratorefractive surgery, IOL exchange, or a piggyback lens.
Gundersen et al7 studied retreatment rates after mul-
tifocal IOL implantation. Retreatments were performed
on 45 of 416 eyes. Bilateral retreatments were performed
 Complex Intraocular Lens Cases   117

A B

C D

Figure 12-10. (A) A broken haptic on a ReSTOR IOL. (B) Subluxated ReSTOR IOL. (C) After moving the initial ReSTOR IOL out
of position (upper IOL) and use of viscoelastic, the IOL for exchange is placed into the capsular bag (lower IOL). (D) Following
proper positioning of the new IOL, the first lens is cut and removed through the small, 0.3-mm incision.

in 19 of 26 patients. Average time from original implanta-
tion to retreatment was 340 days (range: 6 to 20 months).
Implanted IOLs were bilateral trifocal IOLs (FineVision;
PhysIOL SA) in 202 of 416 eyes and blended bifocal IOLs
(Alcon Laboratories, Inc) in 152 of 416 eyes. Corneal astig-
matism greater than 1.0 D increased the risk of retreatment.
The most common reasons patients cited were poor near
acuity, followed by poor distance vision. Near, intermediate,
and distance vision issues accounted for 82% of complaints
leading to retreatment. Retreatments included Epi-LASIK
(2 eyes of 1 patient), Femto-LASIK (3 eyes of 2 patients), and
piggyback lens insertion (40 eyes of 23 patients). No serious
complications were encountered.
Keratorefractive surgery may be used to address resid-
ual refractive error. There is more concern in older patients
and those with basement membrane dystrophy for loose
epithelium.8 There is also a greater incidence of ocular sur-
face disease and dry eye symptoms in the older population,
although LASIK has been found to be safely performed
in patients over 65 years of age.9 For this reason, surface
ablations are sometimes preferred over LASIK to address
residual refractive errors. A refractive demonstration of
the change in vision expected with surface ablation is best
performed using a contact lens while the patient performs
various tasks, such as using the computer at his or her
workstation, reading at his or her preferred distance, or
driving. If the refractive correction does not significantly
improve the symptoms, refractive enhancement should not
be performed. Autorefractions and even manifest refrac-
tions may be problematic after multifocal lens implanta-
tion. Holding loose lenses in front of the problematic eye
may be more beneficial than using the phoropter or trust-
ing the autorefractor.
Case 5
A 73-year-old female underwent ReSTOR implan-
tation, which resulted in a +1.25 D residual refractive
error. The cataract surgeon then performed photorefrac-
tive keratectomy (PRK) to address the refractive error.
Unfortunately, the cornea developed visually significant
corneal scarring and a postoperative refraction of +5.25
-1.25 x 180 (20/50). A second PRK was performed to remove
the scarring and address the hyperopia, leaving a dense cor-
neal scar and residual refractive error of +3.50 -2.00 x 178
(20/200). The surgeon then performed a YAG capsulotomy.
Extremely frustrated, the patient sought a second opinion.
118  Chapter 12
C multifocal IOLs were implanted in 77 eyes of 43 patients.
Figure 12-11. (A) Corneal scar resulting from repeated PRK
treatments to address residual refractive error. (B) After PRK,
20/25 visual acuity was obtained with significant hyperopia. (C)
The residual hyperopia was addressed using a piggyback IOL.
Since the corneal scarring was affecting both visual
acuity and corneal measurements required for IOL calcula-
tion, the cornea was addressed first. A laser PRK with scar
peel to correct the corneal opacity and irregular surface
achieved a clear and measurable cornea. Best-corrected
vision improved to 20/25 through +6.00 -0.25 x 180. A soft
contact lens was worn until the next stage, refractive correc-
tion using a piggyback IOL. Due to the YAG capsulotomy,
IOL exchange was unadvisable. A piggyback lens implant
Figure 12-12. Multifocal toric IOL.
(STAAR AQ 2010V, +9.0 D) resulted in a 20/20 unaided for
distance and J1 (Jaeger) at near with the multifocal IOL in
place (Figure 12-11).
Multifocal IOL implantation in patients with a history of
keratorefractive surgery is more difficult, but previous kera-
torefractive surgery is not necessarily a contraindication.
Vrijman et al10 reported 3-month outcomes after ReSTOR
Eighty-six percent were within ±1.0 D of plano. Sixteen eyes
(20.8%) had laser enhancement because of residual refrac-
tion, and outcomes were less predictable in those with pre-
operative refractive error greater than -6.0 D.10
LASIK, PRK, RK, and lamellar keratoplasty may
increase higher order aberrations, in some cases resulting
in multifocality. This results in a decrease in contrast, par-
ticularly for larger pupil sizes. Implanting a multifocal IOL
with a multifocal cornea may cause an additional loss of
contrast and overall reduction in visual quality.11 Careful
examination of the corneal topography is essential in these
patients. Implantation of a toric IOL in a patient with cen-
tral astigmatism can be challenging (Figure 12-12).
Case 6
A 67-year-old male presented with a history of RK years
ago, followed by cataract surgery with a TECNIS Symfony
IOL 4 months prior. Refraction revealed +0.25 -2.00 x 130
(20/60) with significant shadowing of letters. Dilated fun-
dus exam revealed the implant was decentered superiorly
relative to the pupil. Topography revealed a small, inferiorly
decentered optical zone with increased corneal coma with
a severe inferior-superior value (-10.95 D), spherical aberra-
tion (+0.895 μm). The corneal optic zone was inferior, while
the IOL optic center was superior, resulting in diplopia.
 Complex Intraocular Lens Cases   119

Figure 12-13. (A) Corneal topography of an RK patient. Note the difference in refractive and simulated keratometry
readings, and large inferior-superior value. This patient was not a good candidate for a TECNIS Symfony IOL. (B) The
decentration pictured in the axial map (lower left) manifests as distortion, particularly coma (upper left). The displacement
of the TECNIS Symfony IOL superiorly results in the shadows on the internal Snellen E (upper middle). The whole eye E
(upper right) and corneal E are nearly identical, suggesting the visual performance issues are linked to the cornea, rather
than the TECNIS Symfony IOL.

Angle alpha was 0.667, far too high for comfortable vision
with a premium lens. The lens was exchanged for a monofo-
cal IOL. The patient reported vision appeared brighter and
less blurred the day after surgery. At 1 month, the patient
was able to see 20/30 with +0.75 -1.50 x 135 (Figure 12-13).
Most corneal irregularities, opacities, and residu-
al refractive errors can be successfully addressed using
corneal surgery. Phototherapeutic keratectomy and deep
anterior lamellar keratoplasty can correct opacities.
Topography-guided advanced surface ablation will correct
irregular astigmatism. Fuchs’ dystrophy is corrected using
Descemet stripping automated endothelial keratoplasty
(DSAEK). While these are best performed preoperatively,
they are successful after multifocal IOL implantation.
120  Chapter 12
A B
Figure 12-14. (A) This patient was 20/20 best-corrected vision after ReSTOR followed by PRK for residual refractive error. The
patient sought a second opinion for corrective surgery. The vision loss was due to corneal scarring and irregular astigmatism. (B) A
scar peel was successful in removing corneal haze. The patient was satisfied with the resultant vision and elected to forego further
surface ablation.
In some cases, residual refractive error and patient dis-
satisfaction may require explantation. Explantation may be
performed when demanded by the patient, especially when
the visual complaints began immediately after implantation.
This suggests the implant is the culprit of the complaint. If
the visual complaint was not apparent immediately after
surgery, posterior capsular opacification, ocular surface
disease, or retinal changes must be ruled out. Indications
for IOL explantation include spontaneous IOL in-the-bag
dislocations, incorrect lens power, or failure to neuroadapt
to multifocal IOLs.12 Various lenses may be safely used for
exchange following a multifocal IOL implantation, includ-
ing in-the-bag IOLs, iris-sutured IOLs, sulcus-fixated IOLs
with optic capture, sulcus-fixated IOLs without optic cap-
ture, and anterior chamber IOLs.13 Note that explanting a
lens is rarely performed after a YAG procedure.
PATIENT SYMPTOMATOLOGY
AND DISSATISFACTION
In some cases, patients may not have been adequately
educated about and prepared for the visual side effects of
presbyopic treatments. While the surgeon may deem the
surgery to be perfect, the patient feels burdened by halos,
glare, inability to read small print, and loss of distance
vision. Realistic expectations are paramount to avoid not
meeting patients’ goals post surgery. Some patients can be
negatively or psychologically affected or unprepared for
improper or unexpected endpoints such as glare and halos.
Demonstration of the correction of refractive error may be
performed using contact lenses to determine if the visual
symptoms resolve with correction and reassure the patient.
They may find relief only with exchange of the IOLs.
Case 7
This patient had undergone a diffractive multifocal
+23.0 D SN6AD1 ReSTOR lens implant and was unhappy
with her quality of vision. Initial evaluation revealed
unaided 20/40 vision with significant ocular surface dis-
ease that was corrected with meibomian gland probing
and lacrimal plugs. After improving her dry eye, her
manifest refraction stabilized to -0.25 -0.50 x 065 (20/20).
Simulated demonstration of the refractive error improved
her subjective complaint. She proceeded with a surface
ablation. Her final outcome was 20/20 unaided with plano
refraction (Figure 12-14).
Despite her improved vision following the laser vision
surgery, she returned because she was still angry at her
previous surgeon for not explaining the halos and glare that
could occur with this lens implant. After extensive discus-
sions on multiple occasions with her and her husband in
attendance, she understood her vision had improved and
that she no longer suffered symptoms she had read about
online. Despite the improvement, she felt it was agonizing
for her to live with something that could cause symptoms,
and this was resulting in significant mental anguish. Risk of
a lens exchange in a 20/20 eye was exhaustively discussed,
and an informed consent was created specifically for this
procedure. Her multifocal lens was exchanged with a
+23.50 SN60WF ReSTOR monofocal lens implant. She was
20/25 unaided the next day and 20/20 unaided 1 week later.
She was much more comfortable with this lens choice.
Case 8
This patient suffered a traumatic, subluxated cataract
with dilated pupil, and was referred for pupil repair and
cataract surgery. We discussed her options, and she elected
to avoid pupilloplasty. We realized her dilated eye was the
nondominant eye, and discussed myopia for monovision.
This would result in blur in this eye for distance with

Figure 12-15. This patient was referred after trauma resulted in
permanent mydriasis and subluxated cataractous lens. Knowing
the zonules might be affected, a multifocal IOL is not advisable.
She was motivated for both distance and near correction,
however, complicating the case. The patient preferred to avoid
pupilloplasty. The dilated, nondominant eye was operated on
first, with a myopic endpoint to allow her functional vision at
near while masking the dilated pupil effect upon distance acuity.
The dominant eye was 20/20 at distance after a toric IOL was
implanted.
minimal pupil induced visual impact, while the dominant
eye (with normal pupil) would be corrected to 20/20 unaid-
ed vision. The near and less predictable eye was done first.
The second eye’s outcome becomes more predictable given
the results of the first, allowing the surgeon to fine tune IOL
calculations. This patient resulted in 20/20 at distance and
near without glasses and was very pleased with her vision
despite forgoing the pupilloplasty (Figure 12-15).
Case 9
This patient sought a second opinion after endothe-
lial failure and corneal decompensation following cataract
surgery with a premium toric implant in a cornea with
multiple RK incisions. Prior to corneal decompensation,
the vision had been quite good. Leaving the IOL in place,
modified DSAEK was performed. Due to the astigmatism
in the IOL, sutures should be avoided. Surgery should be as
nonintrusive as possible with thin graft, focused centration,
and secure incision (Figure 12-16).
Complications with multifocal IOLs are more com-
mon than with monofocal IOLs. Many examples here show
proper presurgical work-up is essential to success, as well
an understanding of the optics involved. The increased
demand for spectacle independence also increases the risk
of patient dissatisfaction.
ACKNOWLEDGMENT
Ms. Aaishwariya A. Gulani, (Wharton School of
Business, University of Pennsylvania) for compilation of
cases.
Complex Intraocular Lens Cases   121
Figure 12-16. A toric IOL was implanted in an RK patient who suffered
from corneal decompensation and vision loss. A modified DSAEK with
thin graft, focused centration, and secure incision enabled her to regain
her vision back without disturbing the IOL.
REFERENCES
1. de Vries NE, Webers CA, Touwslager WR, et al. Dissatisfaction after
implantation of multifocal intraocular lenses. J Cataract Refract
Surg. 2011;37(5):859-865.
2. Park CY, Oh SY, Chuck RS. Measurement of angle kappa and centra-
tion in refractive surgery. Curr Opin Ophthalmol. 2012;23(4):269-275.
3. Davison JA. Analysis of capsular bag defects and intraocular
lens positions for consistent centration. J Cataract Refract Surg.
1986;12(2):124-129.
4. Oner FH, Durak I, Soylev M, Ergin M. Long-term results of various
anterior capsulotomies and radial tears on intraocular lens centra-
tion. Ophthalmic Surg Lasers. 2001;32(2):118-123.
5. Pepose JS. Maximizing satisfaction with presbyopia-correct-
ing intraocular lenses: the missing links. Am J Ophthalmol.
2008;146(5):641-648.
6. Alio JL, Abdelghany AA, Fernández-Buenaga R. Enhancements
after cataract surgery. Curr Opin Ophthalmol. 2015;26(1):50-55.
7. Gundersen KG, Makari S, Ostenstad S, Potvin R. Retreatments
after multifocal intraocular lens implantation: an analysis. Clin
Ophthalmol. 2016;10:365-371.
8. Chen YT, Tseng SH, Ma MC, Huang FC. Corneal epithelial
damage during LASIK: a review of 1873 eyes. J Refract Surg.
2007;23(9):916-923.
9. López-Montemayor P, Valdez-García JE, Loya-García D,
Hernandez-Camarena JC. Safety, efficacy and refractive outcomes
of LASIK surgery in patients aged 65 or older. Int Ophthalmol. 2017
Jun 23. doi: 10.1007/s10792-017-0614-3.
10. Vrijman V, van der Linden JW, van der Meulen IJE, Mourits MP,
Lapid-Gortzak R. Multifocal intraocular lens implantation after
previous corneal refractive laser surgery for myopia. J Cataract
Refract Surg. 2017;43(7):909-914. doi: 10.1016/j.jcrs.2017.06.028.
11. Braga-Mele R, Chang D, Dewey S, et al; ASCRS Cataract Clinical
Committee. Multifocal intraocular lenses: relative indications
and contraindications for implantation. J Cataract Refract Surg.
2014;40(2):313-322.
12. Fernández-Buenaga R, Alio JL. Intraocular lens explantation after
cataract surgery: indications, results, and explantation techniques.
Asia Pac J Ophthalmol (Phila). 2017;6(4):372-380. doi: 10.22608/
APO.2017181.
13. Kim EJ, Sajjad A, Montes de Oca I, et al. Refractive outcomes after
multifocal intraocular lens exchange. J Cataract Refract Surg.
2017;43(6):761-766. doi: 10.1016/j.jcrs.2017.03.034.
 SECTION FOUR
Sclera-Based Treatment
for Presbyopia

Scleral Inserts
Barrie Soloway, MD; Y. Ralph Chu, MD; and Jessica Heckman, OD
While Von Hemholtz’s1 lenticular-based theory from
1855 of accommodation and presbyopia continues as the
mainstay of ophthalmic training, over the past 40 years or
so, numerous investigators have found that accommodation
and presbyopia involve a delicate interaction of the varied
contraction of the ciliary muscles in the anterior, equato-
rial, posterior, and vitreous zonules, along with the growth
of the ectodermal lens. In 1987, Coleman2 presented his
zonular theory of accommodation, attributing the changes
in the lens shape to the zonular fibers and lens capsule
forming a diaphragm, which is held in a catenary shape
due to the pressure differential between the aqueous and
vitreous on either side of the lens. Newer work by research-
ers Daniel Goldberg3 and Mary Ann Croft et al4 provides
further insight into the mechanism of accommodation and
the development of presbyopia from a zonular approach.
In these newer theories of accommodation, the ciliary
body moves anteriorly and centripetally, and there is move-
ment of the vitreous interface. These movements affect the
zonules, which, in turn, produce steepening of the anterior
and posterior surfaces of the crystalline lens. These theories
provide the basis for a scleral solution to restore dynamic
accommodation.
- 125 -
13
The VisAbility Micro-Insert System (Refocus Group)
is a binocular presbyopia correction procedure performed
outside the visual axis. Unlike static corrections such as
corneal inlay technologies, monovision or multifocal laser
vision correction, and lens replacement, this procedure
provides a full-range improvement in intermediate to near
vision without compromising distance vision. The micro-
insert system places 4 small locking micro-inserts into pre-
cise scleral tunnels without removing any ocular tissue. As
there is no surgery or change along the visual axis, patients
undergoing VisAbility surgery require no adjustments in
future cataract implant measurements and the procedure
allows for the possibility of future refractive corrections.
Earlier studies of manually positioned micro-inserts have
reported 93% of patients reading 20/40 or better at near at
up to 2 years postoperatively.5 Preliminary data from sur-
gery using the VisAbility Micro-Insert System including
the docking station and scleratome are even better, with
100% of this cohort having binocular uncorrected near
visual acuity of 20/32 (J2 [Jaeger]) and 90% reading 20/25
(J1).6 This procedure has CE mark for Europe and other
countries. It is in Food and Drug Administration–moni-
tored clinical trials in the United States.
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 125-131).
© 2019 SLACK Incorporated.
126  Chapter 13

Figure 13-1. The VisAbility Docking Station with 4-point scleral

fixation. (Reprinted with permission from Refocus Group.)

A B

Figure 13-2. (A) The VisAbility Scleratome creates the tunnel for the implant. (B) The VisAbility Scleratome is shown mated to the
docking station. (Reprinted with permission from Refocus Group.)

segment (Figure 13-4) and the locking insert segment. The

SURGICAL PROCEDURE
The system uses 4 micro-inserts made of biocompatible
polymethyl methacrylate, positioned in precisely cut scleral
tunnels over the oblique quadrants 4.0 mm posterior to
the limbus. Integral to the systematic reproducibility of the
procedure is the novel docking station. The docking sta-
tion (Figure 13-1) provides for fixation of the eye position,
which minimizes surgical trauma; a reference template
for accurate and reproducible tunnel positioning with the
scleratome (Figure 13-2); and stabilization with appropri-
ate tension during tunnel creation and main body segment
insertion. The docking station is held firmly in place with 4
twist tines in the scleral limbus.
Each micro-insert is comprised of 2 pieces that lock
together for stability on the eye (Figure 13-3): the main body
main body segments are implanted in the scleral tunnels
created with the docking station and scleratome. Due to the
position of the anterior ciliary arteries, careful positioning
of the micro-inserts in the oblique quadrants is imperative
to the success and safety of the procedure. Despite exten-
sive collateral circulation, rotated placement of the docking
station will cause compression of multiple anterior ciliary
arteries and increase the risk of anterior segment ischemia.
Unlike strabismus surgery, however, where vessels are cut,
in the unlikely event that the anterior ciliary vessels are
compressed, they can be reopened to restore circulation by
removal of the compressing implants.
Prior to surgery, the 6- and 12-o’clock conjunctival
limbal positions are marked with the patient in the upright
position. A drop of brimonidine is placed in the patient’s
eye to reduce subconjunctival bleeding. It is imperative to

Figure 13-3. The 2-piece VisAbility Micro-Insert consists of the VisAbility Main Body Segment and the VisAbility Locking Insert
Segment, which lock together for stability on the eye. (Reprinted with permission from Refocus Group.)
Figure 13-4. The VisAbility Main Body Segment is placed in the
scleral tunnels created with the docking station and scleratome
by using the feeder tube assembly shown here. The VisAbility
Feeder Tube Assembly is composed of the VisAbility Shuttle
used for guiding it through the scleral tunnel and the feeder
tube used to compress the feet of the main body segment
allowing it to pass through the scleral tunnel without trauma.
(Reprinted with permission from Refocus Group.)
maintain normal pupillary reaction during and after sur-
gery, so dilating drops and epinephrine should be avoided
preoperatively and during surgery. At the surgical micro-
scope, direct visual identification of the rectus muscles
provides for the best precision in marking their insertion
centers radially extended to the limbal cornea. This is cru-
cial to the placement of the docking station and subsequent
micro-insert positions. Figure 13-5 shows the position of
the rectus muscles and their accompanying anterior ciliary
arteries to exemplify this point. Once these landmarks are
Scleral Inserts   127
Figure 13-5. Anatomy of the rectus muscles and their accompanying
anterior ciliary arteries.
identified, the barrel marker (Figure 13-6) is used to mark
the position where the docking station should be placed.
Under topical anesthesia, a 4.0-mm circumferential
peritomy is made in 2 places centered on the 3- and
9-o’clock positions. These are then buttonholed through
Tenon’s capsule to bare sclera posteriorly, avoiding the
horizontal recti muscles. A blunt, large gauge cannula is
then used to hydrodissect between Tenon’s capsule and the
anterior sclera with an injection of 1% lidocaine (without
epinephrine) to anesthetize the eye in a sweeping motion
360 degrees. Approximately 0.25 cc is used in each quad-
rant for a total of 1.0 cc, which is typically adequate for
the entire procedure. A 360-degree conjunctival peritomy
including Tenon’s capsule is then performed, taking care to
ensure that the conjunctival limbus is not torn or stretched.
128  Chapter 13
Figure 13-6. The VisAbility Barrel Marker is used to determine
the exact position of the docking station. (Reprinted with
permission from Refocus Group.)
Inspection to confirm bare sclera 360 degrees is
required for docking station positioning. If Tenon’s capsule
remains in the cardinal positions, it must be removed to
ensure proper fixation of the docking station. To avoid cap-
turing the conjunctiva, the docking station is then placed
underneath the conjunctiva by tucking it underneath the
superior conjunctiva and subsequently draping conjunctiva
over the other quadrants with a tire iron approach. The
docking station is then placed over the geographic corneal
center and rotated to align with the previously placed 6-
and 12-o’clock corneal limbal and barrel marker inking.
Once the docking station is confirmed to be in proper
alignment, it is fixed in place with actuation of the 4 twist
tines.
The scleratome is then used to create the scleral tun-
nels in all 4 oblique quadrants. The scleratome blade guard
fits in the docking station to precisely place these 4.0-mm
tunnels at 400-μm depth, 4.0 mm from the limbus. Upon
completion of each of the 4 tunnels’ creation, the main
body segment is placed using the feeder tube assembly (see
Figure 13-4) consisting of the shuttle, feeder tube, and main
body segment with its feet compressed allowing it to safely
traverse the scleral tunnel. The shuttle at the leading edge
of the feeder tube assembly is advanced through the scleral
tunnel until the feeder tube exits, which is pulled through
to seat the main body segment into position. Once the feet
of the main body segment exits the tunnel, its shoulders
provide counter traction to remove the feeder tube, allow-
ing the feet of the main body segment to return to their nor-
mal position wider than the scleral tunnel. After ensuring
that the internal track of the main body segment is free of
conjunctival or Tenon’s tissue, the locking insert segment is
slid into the main body segment and it is advanced along its
mating track and snapped into place to lock it and create the
2-piece micro-insert. Any Tenon’s capsule or conjunctiva
that might be captured between the feet of the micro-insert
is then swept clear of the feet. This process is repeated for
each of the other 3 quadrants.
After all micro-inserts are in place, the docking station
is removed and tissue glue is used to provide hemostasis
and create a smooth closure of the conjunctiva. Absorbable
9-0 Vicryl (Ethicon) suture is used to ensure conjunctival
closure and prevent any postoperative conjunctival retrac-
tion that might lead to exposure of micro-inserts. At the
completion of the surgery, a silicone punctual plug is placed
in the lower punctum to aid in the prevention of dry eye,
and antibiotic and steroid drops are placed in the eye before
leaving the operating room.
Immediately after surgery, the patient is monitored for
changes in anterior segment perfusion that may lead to ante-
rior segment ischemia. The anterior ciliary arteries enter
the sclera at the insertion of the 4 recti muscles as previous-
ly noted. If the micro-inserts are not properly placed, blood
flow may be restricted to the anterior segment. The earliest
indication of restricted blood flow is decreased iris function
with the pupil appearing dilated and showing minimal or
no response to light.7 A Neuroptics Pupillometer is used to
quantify pupillary function and monitor the patient imme-
diately after surgery (Figure 13-7). In rare instances where
pupillary function was found to be limited and the implants
were removed within 6 hours of surgery, no permanent
signs or symptoms of anterior segment ischemia ensued.
PATIENT SELECTION
The VisAbility Micro-Insert System is intended for
the near emmetropic presbyopic patient who is 45 to 60
years old. The manifest refraction spherical equivalent for a
patient interested in proceeding with this procedure should
be between -0.75 to +0.5 with no more than 1.0 diopters
(D) of astigmatism.8 The prospective patient should have a
best-corrected distance visual acuity of 20/20 and require a
minimum of +1.25 D add to read 20/25 (J1). International
clinical trials of patients having LASIK and VisAbility
Micro-Insert surgery have shown the same results as
patients with natural emmetropia.9 As this procedure
works to improve the eye’s natural ability to accommo-
date, the patient needs to be phakic. Prospective patients
should have normal pupillary function and minimum
scleral thickness of 530 μm as determined by ultrasonic
biomicroscopy or long wave optical coherence tomography.
 Scleral Inserts   129

A B

Figure 13-7. (A) A Neuroptics Pupillometer is used to quantify

pupillary function immediately after surgery. (B) An example of
a Neuroptics Pupillometer printout of healthy pupil function.

Patients with previous extraocular muscle surgery, autoim-

mune disease, or chronic ocular or systemic disease are not
candidates for VisAbility Micro-Insert surgery. In addi-
tion, candidates need to have a good understanding of the
procedure and what is necessary postoperatively to achieve
maximum visual recovery. Patients who are not coachable
or have unrealistic expectations or extreme visual demands
should be avoided.
Preoperative examination of patients interested in
VisAbility Micro-Insert surgery should include a compre-
hensive examination including a complete history along
with slit lamp and dilated fundus examination confirming
normal ocular health. Special testing to screen for ocular
surface disease is beneficial in identifying and pretreating
patients at risk for dryness postoperatively. This special
testing may include sodium fluorescein staining, tear
break-up time, meibomian gland assessment, and ocular
scatter index. Patients found to have preoperative dryness
should be treated appropriately for their diagnosis prior to
consideration of this surgical procedure as the 360-degree
peritomy may exacerbate this dryness. Ultrasound biomi-
croscopy or long wave optical coherence tomography is
used to measure scleral thickness in the superior temporal
quadrant 4.0 mm posterior to the limbus.
POSTOPERATIVE CARE
After surgery, patients are treated with topical steroid
and antibiotic drops on a tapering schedule for the first
1 to 3 weeks. Postoperative examination should include
measurements of pupillary function and monitoring the
positioning of the conjunctiva over the micro-inserts. If
conjunctival retraction and micro-insert exposure occurs,
it will require surgical repositioning and fixation of the
conjunctiva. The conjunctiva should also be monitored for
granuloma or cyst formation, which if either occurs can be
removed if symptomatic.
Patients will often report “tired eyes” early on after
the procedure and notice that their point of near focus has
changed. It is not unusual for some patients to experience
brow ache when reading for the first few weeks after the
procedure, similar to the early effect of pilocarpine drops
or other miotic agents. If this brow ache occurs, the patient
can use acetaminophen, ice compress, or massage to man-
age this discomfort. Patients will have subconjunctival
hemorrhage after micro-insert surgery, and depending on
the degree of hemorrhage it may take 1 to 3 weeks after the
procedure for this to resolve. Educating patients preopera-
tively about these frequent early postoperative findings will
aid with their patience during healing after the procedure
and allows the patient to plan for this period of redness and
potential brow ache. Figure 13-8 shows a picture of an eye
following implantation with the VisAbility Micro-Inserts at
various times postoperatively.
130  Chapter 13

A B

C D

Figure 13-8. (A) Postoperative day 1 appearance. (B) Postoperative day 30 appearance. (C) Postoperative day 90 appearance. (D)
Postoperative day 180 appearance.

Maximum effect with the surgery is directly related
to the time the patient spends reading without glasses.
Discouraging the use of near correction or use of only very
low strength readers and encouragement to use additional
light to avoid their use will assist the patient in achieving
the best long-term function with the procedure. Situations
may arise where a patient may report “I don’t read much.”
In these situations, finding an activity the patient enjoys
pursuing at near, such as solving crossword puzzles or a
mobile phone application specific to patient interests, can
be used in place of traditional on-paper reading to maxi-
mize accommodative function. Preoperative education
regarding the need for their commitment to postoperative
recovery aids in patient compliance and maximizes the
outcome postoperatively.
binocular uncorrected near visual acuity of 20/32 or better,
and 90% achieved 20/25 or better at 12 months postop-
eratively binocularly uncorrected. The mean decrease in
reading add on to distance-corrected near vision required
monocularly in all eyes to read 20/20 postoperatively went
from 1.65 D at baseline to 0.46 D postoperatively
When patient satisfaction was evaluated at a single
site in Investigational Device Exemption G970152, 95%
described the change in near visual performance after
surgery without glasses vs before surgery without glasses as
“significantly better” or “better” at 36 months postopera-
tively.5 Only 5% reported no change to the question, and
none reported worse or significantly worse.

CLINICAL TRIAL RESULTS
In a subsample analysis of data from 2 sites involved
with the US Investigational Device Exemption study, 100%
of primary eyes had a monocular distance-corrected near
visual acuity of 20/40 or better, 95% had 20/32 or bet-
ter, and 63% had 20/25 or better.6 In this study, 100% of
the patients achieved a more real-world situation with
MECHANISM OF ACTION
Advanced theories of accommodation and presbyopia,
such as those advanced by Goldberg3 implicating changes
in zonular geometry due to the age-related growth of
the crystalline lens and Croft’s4 analysis of the posterior
vitreous zonule, postulate that a restoration of accommo-
dation can be accomplished with scleral micro-implant
surgery. Objective evidence of an increase in accommoda-
tion along with spherical aberration–induced depth of field
 Scleral Inserts   131

improvement is seen on iTrace (Tracey Technologies) imag-

ing comparing distance to target distances of 1.0 D, 1.5 D,
2.0 D, 2.5 D, and 3.0 D stimuli from top to bottom (Figure
13-9).

CONCLUSION
The VisAbility Micro-Insert System provides a full
range and consistent improvement in intermediate and
near vision without compromise to distance acuity. The
procedure is performed binocularly outside of the visual
axis to provide a natural improvement in near vision. There
is minimal neurological adaptation, as is typically needed
in static corrections of presbyopia, because the refractive
status of a patient undergoing the procedure remains con-
stant.10 The main ingredients to patients’ success with the
procedure are careful preoperative patient selection and
education, successful surgical implantation and limbal
conjunctival repair, successful postoperative management
of any ocular surface dryness, managing patient’s expecta-
tions, and encouragement of patient compliance in reading
without glasses to maintain and maximize effect.

REFERENCES
1. Von Helmholtz HH. Helmholtz’s treatise on physiological optics. In:
Southall JPC, ed. Mechanism of Accommodation. Vols 1 and 2. New
York, NY: Dover Publications; 1909:143-172.
2. Coleman DJ. On the hydraulic suspension theory of accommoda-
tion. Trans Am Ophthalmol Soc. 1987;84:846-868.
3. Goldberg DB. Computer-animated model of accommoda-
tion and theory of reciprocal zonular action. Clin Ophthalmol.
2011;5:1559-1566.
4. Croft MA, McDonald JP, Katz A, Lin TL, Lutjen-Drecoll E,
Kaufman PL. Extralenticular and lenticular aspects of accom-
modation and presbyopia in human versus monkey eyes. Invest
Ophthalmol Vis Sci. 2013;54(7):5035-5048.
5. Schanzlin D. Preliminary results of USA IDE trials of Refocus scler-
al implants. Paper presented at: American Society of Cataract and
Refractive Surgery Annual Meeting; April 2013; San Francisco, CA.
6. Bucci F, Chu R. Improved near vision acuity: subsample analysis of
patients receiving scleral implants for the treatment of presbyopia.
Paper presented at: American Society of Cataract and Refractive
Surgery Annual Meeting; May 2017; Los Angeles, CA.
7. Wilson WA, Irvine SR. Pathologic changes following disruption of
blood supply to iris and ciliary body. Trans Am Acad Ophthalmol
Otolaryngol. 1955;59(4):501-502.
8. Soloway B. Managing the emmetropic presbyopia: surgical tech-
nique of bilateral scleral Micro-Inserts for presbyopia reversal.
Paper presented at: American Society of Cataract and Refractive
Surgery Annual Meeting; May 2017; Los Angeles, CA.
9. Schanzlin D, Meyer J, Katz J, Soloway B. Improvement in both
distance and near acuity in hyperopic patients after scleral micro-
implant surgery for presbyopia and laser vision correction of mani-
fest hyperopia. Paper presented at: American Society of Cataract and
Refractive Surgery Annual Meeting; May 2017; Los Angeles, CA.
10. Soloway B. Refractive stability through 12 month post-operative Figure 13-9. An increase in accommodation along with spherical
in patients with scleral implants for presbyopia correction. Paper aberration–induced depth of field is seen on iTrace at target
presented at: American Society of Cataract and Refractive Surgery distances of 1.0 D, 1.5 D, 2.0 D, 2.5 D, and 3.0 D stimuli from top
Annual Meeting; May 2017; Los Angeles, CA. to bottom.
 14
Laser Scleral
Microporation Procedure

AnnMarie Hipsley, PhD, DPT; David H. K. Ma, MD, PhD;

Karolinne M. Rocha, MD, PhD; and Brad Hall, PhD

There are several available treatment options for pres-

byopes including spectacles, contact lenses, corneal surgery,
or nonaccommodative intraocular lenses. Spectacles and
contact lenses are the prevailing treatments.1 However, none
of these options aim to restore true physiological dynamic
accommodation. While these options are effective for treat-
ing the symptoms of presbyopia, there remains a need for
a procedure that can restore dynamic accommodation and
potentially rejuvenate ocular rigidity that occurs with age
that may impact other physiological functions of the eye.
Laser scleral ablation has the potential to fill this need.
Excimer lasers emit radiation in the far ultraviolet light
spectra (0.19 to 0.35 μm), and have been used successfully
in refractive surgery to correct refractive errors of the eye
for almost 3 decades.2,3 Lasers in this wavelength allow Figure 14-1. Absorption spectrum of water across different wavelengths.
precise removal of corneal tissue by means of photochemi-
cal laser tissue interaction breaking molecular bonds in it coincides with the peak absorption of water (3.00 μm),
the tissue and reshaping the cornea.4 Mid-infrared lasers giving it a unique clinical application that is more photo-
(0.7 to 1000 μm) are frequently used in clinical applica- mechanical than photothermal.8 When an Er:YAG laser
tions because they remove tissue with less thermal damage beam is well absorbed at the target, it can cause rapid vapor-
to surrounding tissues.5-7 Near infrared lasers, such as ization, or ablation, in both hard and soft tissues. Here we
erbium: yttrium-aluminum-garnet (Er:YAG) lasers, have demonstrate a novel, minimally invasive, nonablative, laser
several advantages over other mid-infrared lasers. Er:YAG eye therapy that is based on thermally inducing a micro-
lasers are solid-state lasers, using an erbium-doped yttri- poration of the sclera in a mathematical matrix array using
um-aluminum-garnet as the medium, and typically emit an Er:YAG laser. The Er:YAG laser wavelength of 2.94 μm is
mid-infrared light with a wavelength of 2.94 μm (Figure strongly absorbed in water, which is the major constituent
14-1). This wavelength is strongly absorbed by water as
Wang M, ed.
- 133 - Surgical Correction of Presbyopia: The Fifth Wave (pp 133-142).
© 2019 SLACK Incorporated.
134  Chapter 14

TABLE 14-1
LASER ABSORPTION, PENETRATION, AND THERMAL DIFFUSION TIME IN THE SCLERA
Laser Wavelength (λ) (μm) Absorption Light Penetration Thermal Diffusion
Coefficient (μa) (cm-1) Depth (δ) (μm) Time (τ) (ms)
Excimer 0.16 to 0.35 5 1 to 10 1.7
Ho:YAG 2.1 35 89 13
Tm:YAG 2.1 35 89 13
Nd:YAG 1.1 25 1130 2100
Er:YAG 2.9 9000 1 0.0017
Er = erbium; Ho = holmium; Nd = neodymium; Tm = thulium; YAG = yttrium-aluminum-garnet
Adapted from Welch AJ, Van Gemert MJ. Optical-Thermal Response of Laser-Irradiated Tissue. New York, NY: Plenum Press; 1995; Bashkatov A,
Genina E, Kochubey V, Tuchin V. Optical properties of human sclera in spectral range 370–2500 nm. Optics and Spectroscopy. 2010;109(2):197-204.

of human soft tissue. A precisely controlled sequence(s) of
subablative Er:YAG laser pulses are delivered to scleral tis-
sue in order to achieve controlled heating of the collagen
in the deeper microfibril layers, without overheating the
tissue. Therefore, tissue removal is very precise with virtu-
ally no collateral thermal damage due to the coincidence
of Er:YAG wavelength to the absorption peak of water.
All soft tissue, because of its high water content, is ablated
very efficiently.8 For this reason, pulsed Er:YAG lasers have
been used safely and successfully since the early 1990s in
many medical laser surgery applications, such as cosmetic,
dermatology, urology, and dental laser surgery.5-7 Er:YAG
lasers (2.94 μm) have also been the preferred wavelength in
the spectrum over CO2 lasers and other YAG lasers in vari-
ous wavelengths because it is absorbed almost 10 million
times more than visible light wavelengths, and 10 thousand
times more than by the output of neodymium:YAG lasers
decreasing thermal damage significantly (see Figure 14-1).
Controlling thermal damage is of clinical significance
when utilizing lasers as a treatment method in soft tissue,
where an increased thermal damage zone has a known
effect on wound healing, which imposes subsequent safety,
efficacy, and stability implications.
A unique safety feature of the Er:YAG is that it has the
lowest thermal diffusion than any other laser in the mid-
infrared spectrum. This is beneficial because a low thermal
diffusion time and a shorter laser pulse is needed for the
thermal energy from the laser to propagate into scleral tis-
sue.9 Table 14-1 compares the absorption, penetration, and
thermal diffusion time in the sclera for 5 types of lasers.
When compared to other wavelengths, Er:YAG has the
highest absorption by 2 orders of magnitude. Additionally,
the light penetration depth of Er:YAG is the lowest by 1 to 3
orders of magnitude. Compared to Er:YAG, Holmium:YAG
and Thulium:YAG have 2 orders of magnitude higher pen-
etration and 2 orders of magnitude lower absorption. The
high absorption and low penetration are a unique safety
feature of using the Er:YAG laser in the eye. Furthermore,
this particular Er:YAG wavelength has very low spectral
properties and therefore presents very low risk of light scat-
ter of the laser beam to other tissues of the eye.
Laser scleral ablation procedures to treat presbyopia
began as an improvement to a procedure known as anterior
ciliary sclerotomy (ACS). ACS involved radial or spoke inci-
sions, with a knife or radiofrequency blade, through sclera
overlaying the ciliary muscle.10 The ACS procedure aimed
to increase the space between the ciliary muscle and the
lens, tightening the zonules and restoring dynamic accom-
modation.11 Accommodation was observed to improve
slightly with ACS; however, long-term results suggest that
the procedure was unsuccessful at restoring accommoda-
tion.11 Lin and colleagues argued that the rapid wound
healing of the sclera following ACS was responsible for the
poor long-term results, and proposed instead to use Er:YAG
laser ablation in the sclera (radial sclerectomy).12,13 This
procedure was termed laser presbyopia reversal (LAPR),
and the results of LAPR were largely mixed. Both ACS and
LAPR are no longer available, however, there were compel-
ling results of effectiveness that still left unanswered ques-
tions about how scleral ablative therapies were affecting
near and intermediate vision with a measurable effect.11-13
RESTORATION OF
DYNAMIC ACCOMMODATION
The loss of dynamic accommodation with age is
complex and not yet fully understood. Von Helmholtz14
argued that the reduction of accommodative ability in
presbyopes was caused by the loss of elasticity of the lens
substance. Conversely, Schachar argued that accommoda-
tive ability declines because of a decreasing gap between
the lens perimeter and the ciliary ring with age.15 Recent
evidence has also highlighted many extralenticular factors
(primarily the zonules, choroid, and sclera) that influence
the loss of accommodative ability with age.16,17 Using a
computer-animated model, Goldberg also demonstrated
the influence of extralenticular factors, specifically that

Figure 14-2. (A) LaserACE surgical technique. (B) LaserACE 3 critical zones of physiological significance.
the sclera moves during accommodation.18 Additionally,
ocular rigidity has been correlated with a clinically signifi-
cant loss of accommodation with age.19 Goldberg18 further
demonstrated in his model the relationship between the
forward and centripetal movement of the ciliary muscles,
which is proportional to changes in the central optical
power of the crystalline lens. Lenticular accommodation is
also proportional to the change in distance between the ora
serrata and the sclera spur landmarks of the ciliary muscle
attachments.18,20-22
Based on these recently illuminated biomechanical fac-
tors in accommodation loss,18,21-24 Laser Anterior Ciliary
Excision (LaserACE [Ace Vision Group]) is an eye laser
therapy designed to reduce ocular rigidity and create com-
pliance in the scleral tissue using a laser-generated matrix
of microporations (micropores). As the connective tissues
in the eye age, the collagen and elastin within continuously
crosslink to form fibrils and microfibrils, which increases
scleral stiffness.25,26 A rigid sclera compresses and exerts
stress on underlying structures, leading to their biome-
chanical dysfunction, and specifically structures related to
accommodation.27-30 LaserACE produces an uncrosslink-
ing effect in scleral tissue, alleviating stress over key physi-
ological anatomy that lies directly beneath the aging scleral
tissue, such as the ciliary muscle and the accommodation
complex. The procedure utilizes an Er:YAG laser (VisioLite)
to create microporations in 3 critical zones (Figure 14-2)
without touching any components or relative tissues of the
cornea. The 3 zones are as follows18,21-24:
1. The scleral spur at the origin of the ciliary muscle
(0.5 to 1.1 mm from the anatomical limbus)
2. The mid ciliary muscle body (1.1 to 4.9 mm from
the anatomical limbus)
3. Insertion of the longitudinal muscle fibers of the
ciliary, just anterior to the ora serrata at the inser-
tion zone of the posterior vitreous zonules (4.9 to
5.5 mm from the anatomical limbus)
The procedure uses a laser frequency of 10 to 30 Hz, a
laser fluence of 30 to 50 mJ/cm2, and a spot size of 600 μm.
Laser Scleral Microporation Procedure   135
Microporations are placed in a 5.0-mm x 5.0-mm matrix
pattern in 4 oblique quadrants of the eye, using a fiber
handpiece and near-contact 80-degree curved tip (see
Figure 14-2). Each micropore has a depth to about 90% the
depth of the sclera, the point that the blue hue of the cho-
roid is just visible.
An overview of the LaserACE surgical procedure is
shown in Figure 14-3. The surgery is performed bilaterally
on the same day, with each eye taking approximately 10 to
15 minutes to complete. Prior to the procedure, topical anti-
biotics and anesthetics are used, as well as orally adminis-
tered benzodiazepines. To protect the cornea, an opaque
corneal shield is placed on the cornea for the duration of
the procedure.
A collagen matrix powder (Collawound, Collamatrix)
is applied directly over the scleral ablation matrices with a
cannula. This degradable collagen matrix temporarily fills
the microporations, preventing fibrosis. An 18.0-mm plano
bandage scleral contact lens (methafilcon A) is used postop-
eratively to cover the ablation zones and hold the collagen in
place. Topical antibiotics and steroids are used are used for 1
week postoperatively, followed by a steroid taper for 2 weeks.
CLINICAL RESULTS
In 2016, Ace Vision Group completed Institutional
Review Board-approved phase III clinical trials, in Taiwan
at the Chang Gung Memorial Hospital, investigating the
visual performance of 26 patients up to 24 months post-
operatively after LaserACE treatment. Uncorrected and
corrected distance visual acuities were measured at near,
intermediate, and distance (40 cm, 60 cm, 4 m) using stan-
dard Early Treatment Diabetic Retinopathy Study charts.
Patient-reported satisfaction and patient-reported visual
function were investigated using the Catquest 9SF Survey.31
Additionally, intraocular pressure (IOP) was measured
using a pneumatic tonometer, and stereoacuity was mea-
sured using the Randot stereoscopic test.
136  Chapter 14

Figure 14-3. LaserACE surgical procedure. (A) Quadrant marker. (B) Matrix marker. (C) Corneal shield. (D) LaserACE micropore
ablation. (E) Subconjunctival collagen. (F) Completed 4 quadrants. (Reprinted with permission from Hipsley A, Ma DH, Sun CC,
Jackson MA, Goldberg D, Hall B. Visual outcomes 24 months after LaserACE. Eye Vis. 2017;4:15. https://creativecommons.org/
licenses/by/4.0/; https://creativecommons.org/publicdomain/zero/1.0/.)

TABLE 14-2
PREOPERATIVE PATIENT DEMOGRAPHICS
Emmetrope Emmetropic Myope Emmetropic LVC Myope
Hyperope
Gender Male = 4 Male = 4 Male = 3 Male = 1
Female = 2 Female = 2 Female = 7 Female = 3
N 6 6 10 4
Spherical 0 -0.3 D ± 0.11 D 0.5 D ± 0.25 D 0.25 D ± 0.35 D
Equivalent Refraction
(mean ± SD)
Cylinder (mean ± SD) -0.17 D ± 0.14 D -0.15 D ± 0.22 D 0.0 D ± 0.22 D -0.19 D ± 0.38 D
CDVA ≥ 20/25 100% 100% 100% 100%
CDVA ≥ 20/20 100% 100% 100% 100%
CDVA ≥ 20/16 100% 100% 80% 100%
CDVA = corrected distance visual acuity; LVC = laser vision corrected

Twenty-one of the 26 patients enrolled completed 24
months of postoperative care. Five patients withdrew due
to occupational travel conflicts. Patient demographics are
shown in Table 14-2. Preoperative corneal refractive status
influenced visual outcomes in this clinical trial. Therefore,
to understand the specific effects on the visual acuity,
patients were split into 4 groups. Patients who were close
to 0 were defined as true emmetropes, patients between
-0.25 to -0.5 diopters (D) were defined as emmetropic
myopes, patients between +0.25 D to +0.5 D were defined as
emmetropic hyperopes, and 4 patients were status post laser
vision corrected. The results show significant improve-
ments in visual performance for near and intermediate,
while distance visual performance remained stable. Figure
14-4 shows the average spherical equivalent refraction
overtime for these patients. Patient age ranged from 45 to
64 years, and mean patient age was 49.7 ± 4.37 years. The
refraction was stable overtime with no significant differ-
ence (P = .998) at 24 months postoperatively compared to
preoperative refraction.
Figure 14-5 shows the preoperative and postoperative
binocular patient visual acuities at distance (4 m), interme-
diate (60 cm), and near (40 cm). There were no statistically
significant changes from preoperative visual acuities, in
uncorrected distance visual acuity or CDVA at 24 months
postoperatively. It is interesting to note that the emmetropic
 Laser Scleral Microporation Procedure   137

Figure 14-4. Stability of patient spherical equivalent refraction after LaserACE. Error
bars represent mean ± SD.

Figure 14-5. (A) Uncorrected (lightly colored) and (B) corrected distance
(darkly colored) visual acuity at distance (4 m), intermediate (60 cm), and near
(40 cm). Error bars represent mean ± SD. DCNVA: distance-corrected near
visual acuity; UDVA: uncorrected distance visual acuity; UNVA: uncorrected
near visual acuity. (Adapted with permission from Hipsley A, Ma DH, Sun CC,
Jackson MA, Goldberg D, Hall B. Visual outcomes 24 months after LaserACE.
Eye Vis. 2017;4:15. https://creativecommons.org/licenses/by/4.0/; https://cre-
ativecommons.org/publicdomain/zero/1.0/).

hyperope patients (greater than 0.0 D) did receive a slight
benefit to their distance vision. It is likely that the improved
accommodative ability in these participants is able to cor-
rect a small amount of hyperopia, which does cause an
improvement in the overall average of the distance vision
of all participants but is not statistically significant at 24
months postoperatively.
Near and intermediate visual acuity showed improve-
ments compared to preoperative visual acuity. Uncorrected
near visual acuity improved from +0.20 ± 0.16 logMAR
(about 20/32 Snellen) preoperatively to +0.12 ± 0.14 log-
MAR (about 20/25 Snellen) at 24 months postoperatively
(P = .0014), while distance-corrected near visual acuity
improved from +0.21 ± 0.17 logMAR (about 20/32 Snellen)
preoperatively to +0.11 ± 0.12 logMAR (about 20/25 Snellen)
at 24 months postoperatively (P = .00026). Intermediate
vision was also improved at 24 months postoperatively.
Both uncorrected intermediate visual acuity (UIVA) and
distance-corrected intermediate visual acuity (DCIVA)
improved at all time points compared to preoperative visual
acuities. The improvements in UIVA and DCIVA were not
statistically significant at 24 months postoperatively.
Figure 14-6 shows the average patient line gain in
binocular near visual acuity at 24 months postoperatively
138  Chapter 14

Figure 14-6. Average patient line gain in binocular near visual acuity at 24 months
postoperatively compared to preoperatively. Error bars represent mean ± SD.

Figure 14-7. Average participant ratings from the Catquest 9SF survey. Responses ranged from +2, indicating
no difficulty, to -2, indicating great difficulty. Error bars represent mean ± standard error [SE]. (Adapted with
permission from Hipsley A, Ma DH, Sun CC, Jackson MA, Goldberg D, Hall B. Visual outcomes 24 months
after LaserACE. Eye Vis. 2017;4:15. https://creativecommons.org/licenses/by/4.0/; https://creativecommons.org/
publicdomain/zero/1.0/.)

compared to preoperatively. Older participants generally 24 months postoperatively (P = .0052). Patient-reported

gained more lines of near visual acuity, compared to early
presbyopes. This is not unexpected, as the loss of near
visual acuity in presbyopes is progressive.32 A patient may
lose 1 line of near visual acuity by age 40, while at age 60 he
or she may have lost 4 lines.33
Figure 14-7 shows the patient-reported visual function
from the Catquest 9SF survey. Patient ratings for near tasks
ranged from -2 (great difficulty) to +2 (no difficulty).
Patients indicated improvements in each of the 8 cat-
egories of visual function. The largest reported improve-
ment was for seeing during handwork, which improved
from -0.15 (SE = 0.32) preoperatively to 0.94 (SE 0.34) at
satisfaction scores ranged from -2 (very dissatisfied) to +2
(very satisfied). Satisfaction scores significantly improved
from -1.00 (SE = 0.22) preoperatively to 0.33 (SE = 0.36) at 24
months postoperatively (P = .000016).
Figure 14-8 shows the postoperative changes in IOP.
Patient IOP significantly improved from 13.56 ± 3.23 preop-
eratively to 11.74 ± 2.64 mmHg at 24 months postoperatively
(P = .000063). Pallikaris and colleagues17 demonstrated in
human living eyes that age-related increase in ocular rigid-
ity has clinical significance and correlates with age-related
dysfunction and disease of the eye. The reduction in IOP
after the LaserACE procedure is also an encouraging side

Figure 14-8. Postoperative changes in IOP of patient eyes. Error bars represent mean ± SD.
Figure 14-9. Postoperative changes in stereoacuity of patient eyes. Error bars represent mean ± SD.
effect that prompts further investigation into the potential
health impact that scleral microporation procedures may
have on the aging eye organ. Average patient IOP was
reduced by approximately 13% at 24 months postopera-
tively compared to preoperative IOP. These IOP-reducing
effects of LaserACE have the potential to help ocular hyper-
tensive or glaucoma patients.
Figure 14-9 shows the postoperative changes in stereo-
acuity. Stereoacuity improved to 58.6 ± 22.9 seconds of arc at
24 months postoperatively, compared to 75.8 ± 29.3 seconds
of arc preoperatively. These improvements in stereoacuity
are notable as other treatments for presbyopia can decrease
binocularity and stereopsis. Inducing monovision, either by
contact lenses or surgically, intentionally decreases stereop-
sis and binocularity.34 Loss of binocularity and stereopsis is
also a risk factor for corneal presbyopic correction.35
A previous multicenter international pilot study
(Mexico, Canada, Europe, South America) investigated
the effect of the LaserACE procedure on objective accom-
modation of 80 eyes of 40 patients.24 Objective accommo-
dation was measured using wavefront aberrometry with
the iTrace dynamic aberrometer (Tracey Technologies)
Laser Scleral Microporation Procedure   139
or the Complete Ophthalmic Analysis System (COAS)
Shack-Hartmann aberrometer with dynamic stimulation
aberrometry (Wavefront Sciences). Figure 14-10 shows the
average patient accommodative amplitude preoperatively
up to 18 months postoperatively. The average increase in
amplitude of accommodation over time is between 1.25 D
to 1.5 D. Note that no patient lost accommodative ampli-
tude. Figure 14-11 is a representative figure of sphere and
pupil diameter (mm) during internal dynamic accommo-
dative push up ranging from 0.0 D to 5.0 D for a young
control patient, a patient preoperatively, and the same
patient postoperatively after LaserACE. For the young
control patient (see Figure 14-11A) there is a large change
in sphere and a corresponding change in pupil diameter.
Preoperatively, the LaserACE patient showed no signifi-
cant or parallel change in sphere corresponding with pupil
diameter. Postoperatively, the LaserACE patient showed a
remarkable change in sphere along with a corresponding
change in pupil diameter. This indicates restored pupil
reflexivity with sphere response after LaserACE. Figures
14-12 and 14-13 are representative figures of wavefront
profiles (COAS aberrometer) and point spread function
profiles during internal dynamic accommodative push up
140  Chapter 14

Figure 14-10. Objectively measured patient accommodative amplitude. Error bars represent mean ± SD.

Figure 14-11. Representative figure for changes in sphere (red) and pupil diameter (blue)
during internal dynamic accommodative push up for (A) young control patient, (B) LaserACE
patient preoperatively, and (C) the same patient postoperatively after LaserACE.
 Laser Scleral Microporation Procedure   141

Figure 14-12. Representative figure of wavefront profiles during internal dynamic accommodative push up for (A) young control
patient, (B) LaserACE patient preoperatively, and (C) the same patient postoperatively after LaserACE.

Figure 14-13. Representative figure of point spread function profiles during internal dynamic accommodative push up for (A)
young control patient, (B) LaserACE patient preoperatively, and (C) the same patient postoperatively after LaserACE.

for a young control patient, a patient preoperatively, and the
same patient postoperatively after LaserACE. The control
patient was myopic with spectacle distance correction to
plano, and the LaserACE patient was myopic with LASIK
distance correction to plano. After LaserACE treatment, the
patient’s wavefront and point spread function profiles were
similar to that of the young control myope, which is indica-
tive of a restored accommodative response, which would be
more typical of a younger patient.
CONCLUSION
Initial pilot studies were corroborated with Taiwan
clinical trial results for the LaserACE procedure and indi-
cate that the treatment is both effective and safe in 126
eyes of 63 patients for at least 24 months postoperatively.
Objectively measured accommodation improved following
the procedure and remained through to 18 months. These
results indicate that the procedure could restore 1.25 D to
1.5 D of accommodation. This is equivalent to a rejuvena-
tion of 5 to 10 years for presbyopes. Additionally, both
near and intermediate visual acuity were improved imme-
diately following the procedure, and these improvements
remained through to 24 months postoperatively. No cases
of lost best-corrected distance visual acuity, persistent
hypotony, or cystoid macular edema occurred in any of the
participants. SE refraction remained stable following the
procedure through to 24 months postoperatively. Patient-
reported satisfaction and patient-reported visual func-
tion also improved postoperatively and were maintained
through to 24 months postoperatively.
The LaserACE procedure limits treatment to the sclera,
which has several advantages over more invasive proce-
dures to treat presbyopia. The risk of vision loss is mini-
mized, as the cornea, visual axis, and native crystalline lens
remain untouched allowing for future corneal or cataract
procedures. Additionally, because treatment is limited to
the sclera, LaserACE can be combined with or used follow-
ing other procedures. LaserACE patients who were emme-
tropic due to previous laser vision correction procedures
had the same visual acuity and accommodation improve-
ments as other patients. LaserACE could also be potentially
combined with accommodative intraocular lenses, mono-
vision, mini-monovision, blended vision, or PresbyLASIK.
Additionally, data suggest that the LaserACE procedure
could be titered from the onset of presbyopia throughout its
stages with younger persons requiring less treatment than
older persons. To date, there have been no retreatments,
however, retreatments do appear possible with further
investigation of treatment algorithms correlated to biome-
chanical stiffness of the sclera and age.
142  Chapter 14
Future research is required to increase the data pool
and to measure longer-term outcomes and optimize treat-
ment algorithms. Patient selection, lens hardening, and
optical profile may be seen to affect results. These studies
will be aimed at the comprehensive analyses of accommo-
dation biometrics, aberrometry profiling, reading speed,
and dynamic functions before and after the procedure. In
addition, ethnic variability as well as procedure duration of
effectiveness will be studied. Virgin eye comparison with
LaserACE patients who have been treated with laser vision
correction to plano will also be assessed. Larger sample
sizes in both myopic emmetropic and hyperopic emme-
tropic groups are needed to investigate the differences in
outcomes between groups (see Table 14-1). As the under-
standing of the mechanisms of accommodation and scleral
laser treatments broaden, further and new technological
progression is possible. Future studies may also show that
laser scleral ablation may have additional health benefits,
such as reducing IOP significantly in glaucoma patients.
Ocular (scleral) biomechanics is becoming a field
of its own with clinical applications such as glaucoma,
ocular drug delivery, and presbyopia. The future of this
space is in its infancy and continues to be an intriguing
anatomical area for investigation. The treatment potential
for applications encompassing the globe remains largely
undiscovered, yet new laser light wavelengths and technol-
ogy advancements make it possible to explore innovative
ways to treat disease and dysfunction of the eye organ. The
overarching implications are not only plausible but may be,
in fact, on the horizon.
REFERENCES
1. Charman WN. Developments in the correction of presbyopia I:
spectacle and contact lenses. Ophthalmic and Physiological Optics.
2014;34(1):8-29.
2. Kugler LJ, Wang MX. Lasers in refractive surgery: history, present,
and future. Appl Opt. 2010;49(25):F1-F9.
3. Manche EE, Carr JD, Haw WW, Hersh PS. Excimer laser refractive
surgery. West J Med. 1998;169(1):30-38.
4. Trokel SL, Srinivasan R, Braren B. Excimer laser surgery of the cor-
nea. Am J Ophthalmol. 1983;96(6):710-715.
5. Marks AJ, Teichman JM. Lasers in clinical urology: state of the art
and new horizons. World J Urol. 2007;25(3):227-233.
6. Wigdor HA, Walsh JT, Featherstone JD, Visuri SR, Fried D, Waldvogel
JL. Lasers in dentistry. Lasers Surg Med. 1995;16(2):103-133.
7. Alam M, Hsu TS, Dover JS, Wrone DA, Arndt KA. Nonablative laser
and light treatments: histology and tissue effects—a review. Lasers
Surg Med. 2003;33(1):30-39.
8. Kudryashov I, Katsnelson A. Q-switched resonantly diode-pumped
Er: YAG laser. Paper presented at: The International Society for
Optical Engineering LASE; March 3, 2010; San Francisco, CA. doi:
10.1117/12.841038.
9. Welch AJ, Van Gemert MJ. Optical-Thermal Response of Laser-
Irradiated Tissue. New York, NY: Plenum Press; 1995.
10. Thornton SP. Anterior ciliary sclerotomy (ACS), a procedure to
reverse presbyopia. In: Sher NA, ed. Surgery for Hyperopia and
Presbyopia. Baltimore, MD: Williams & Wilkins; 1997:33-36.
11. Hamilton DR, Davidorf JM, Maloney RK. Anterior ciliary scle-
rotomy for treatment of presbyopia: a prospective controlled study.
Ophthalmology. 2002;109(11):1970-1976.
12. Lin JT, Kadambi V. The new mechanism of laser presbyopia rever-
sal and accommodation. In: Agarwal A, ed. Presbyopia: A Surgical
Textbook. Thorofare, NJ: SLACK Incorporated; 2002: 63-70.
13. Lin JT, Mallo O. Treatment of presbyopia by infrared laser radial
sclerectomy. J Refract Surg. 2003;19(4):465-467.
14. Von Helmholtz H. Mechanism of accommodation. Helmholtz’s
Treatise on Physiological Optics. Vol 1. [Trans from the 3rd German
ed.] 1924:143-172.
15. Schachar RA. Zonular function: a new hypothesis with clinical
implications. Ann Ophthalmol. 1994;26(2): 36-38.
16. Wilde GS. Measurement of human lens stiffness for modelling
presbyopia treatments [dissertation]. Oxford, United Kingdom:
University of Oxford; 2011.
17. Pallikaris IG, Kymionis GD, Ginis HS, Kounis GA, Tsilimbaris MK.
Ocular rigidity in living human eyes. Invest Ophthalmol Vis Sci.
2005;46(2):409-414.
18. Goldberg DB. Computer-animated model of accommodation and
presbyopia. J Cataract Refract Surg. 2015;41(2):437-445.
19. Detorakis ET, Pallikaris IG. Ocular rigidity: biomechanical role, in
vivo measurements and clinical significance. Clin Exp Ophthalmol.
2013;41(1):73-81.
20. Richdale K, Sinnott LT, Bullimore MA, et al. Quantification of
age-related and per diopter accommodative changes of the lens
and ciliary muscle in the emmetropic human eyelens and ciliary
muscle with age and accommodation. Invest Ophthalmol Vis Sci.
2013;54(2):1095-1105.
21. Croft MA, McDonald JP, Katz A, Lin TL, Lütjen-Drecoll E,
Kaufman PL. Extralenticular and lenticular aspects of accom-
modation and presbyopia in human versus monkey eyes. Invest
Ophthalmol Vis Sci. 2013;54(7):5035-5048.
22. Lütjen-Drecoll E, Kaufman PL, Wasielewski R, Ting-Li L, Croft
MA. Morphology and accommodative function of the vitreous
zonule in human and monkey eyes. Invest Ophthalmol Vis Sci.
2010;51(3):1554-1564.
23. Hipsley A, Dementiev D. VisioDynamics theory: a biomechani-
cal model for the aging ocular organ. In: Ashok G, Urzua G,
Dementiev D, Pinelli R, eds. Step by Step Innovations in Presbyopia
Management. New Delhi, India: Jaypee Brothers Medical Publishers;
2006:269-315.
24. Hipsley A, McDonald M. Laser scleral matrix microexcisions
(LaserACE/erbium YAG laser). In: Pallikaris IG, Plainis S, Charman
WN, eds. Presbyopia: Origins, Effects, and Treatment. Thorofare,
NJ: SLACK Incorporated; 2012:219-225.
25. Bailey AJ. Molecular mechanisms of ageing in connective tissues.
Mech Ageing Dev. 2001;122(7):735-755.
26. Schofield J, Weightman B. New knowledge of connective tissue age-
ing. J Clin Pathol. 1978;3(1):174-190.
27. Ethier CR, Johnson M, Ruberti J. Ocular biomechanics and bio-
transport. Annu Rev Biomed Eng. 2004;6:249-273.
28. Fazio MA, Grytz R, Morris JS, Bruno L, Girkin CA, Downs JC.
Human scleral structural stiffness increases more rapidly with
age in donors of african descent compared to donors of european
descent. Invest Ophthalmol Vis Sci. 2014;55(11):7189-7198.
29. Grytz R, Fazio MA, Girard MJA, et al. Material properties of the pos-
terior human sclera. J Mech Behav Biomed Mater. 2014;29:602-617
30. Grytz R, Fazio MA, Libertiaux V, et al. Age-and race-related
differences in human scleral material properties: scleral mate-
rial property changes with age and race. Invest Ophthalmol Vis Sci.
2014;55(12):8163-8172.
31. Lundström M, Roos P, Jensen S, Fregell G. Catquest questionnaire
for use in cataract surgery care: description, validity, and reliability.
J Cataract Refract Surg. 1997;23(8):1226-1236.
32. Roberts J. Binocular Visual Acuity of Adults. Washington, DC: US
Department of Health, Education and Welfare; 1964.
33. Taylor HR, Livingston PM, Stanislavsky YL, McCarty CA. Visual
impairment in Australia: distance visual acuity, near vision, and
visual field findings of the Melbourne Visual Impairment Project.
Am J Ophthalmol. 1997;123(3):328-337.
34. Evans BJ. Monovision: a review. Ophthalmic Physiol Opt.
2007;27(5):417-439.
35. O’Keefe M, O’Keeffe N. Corneal surgical approach in the treatment
of presbyopia. J Clin Exp Ophthalmol. 2016;7(1):1-4.
 SECTION FIVE
Marketing Issues and
Future Technologies

Marketing Surgical
Treatment for Presbyopia
Shareef Mahdavi, BA; Li Jiang, MD; and Ming Wang, MD, PhD
America is aging. Four million people become pres-
byopic each year. By 2017, the number of presbyopes in the
United States was expected to reach 161 million people.
According to a global report on presbyopia issued by
Market Scope, among the 7.4 billion people in the world
today, nearly 1.8 billion of them have presbyopia.1 The
same report indicated this number is expected to soar to
2.1 billion by 2020. Presbyopic patients, especially plano
presbyopes, do not like wearing reading glasses. They feel
the glasses are inconvenient and make them look older.
We the authors share the frustration felt on a nearly
universal basis when it comes to presbyopia and how to
market solutions to this specific malady. This chapter aims
to shed light on the topic and help surgeons understand
both why presbyopia offers the single greatest marketing
challenge and how surgeons should approach this chal-
lenge, as well as what they should avoid.
WHAT IS MARKETING?
Let us clarify what marketing is and is not. Marketing
is not sales. Within a medical practice, selling is a specific
- 145 -
15
discipline that involves the agreement by one party (the
patient) to compensate the other party (the surgeon and
practice) in exchange for a set of services (vision improve-
ment). Marketing’s role is to create the context and environ-
ment for the sale to happen. Marketing involves a broad
set of tasks that range from creating awareness and devel-
oping influence to education and postoperative support.
Marketing involves communication, and in the medical
practice everything communicates. This principle implies
that while not everybody on the staff is in sales, every indi-
vidual is in marketing.
Similarly, marketing is far more than advertising.
Advertising has been defined as the price you pay for
being unremarkable. Indeed, the bias of the authors is that
a greater focus on the unpaid forms of marketing, which
extend into customer service and customer experience,
provide far more sustainable advantage to the practice than
ongoing investment into paid promotion. While there is a
role for advertising, it can only serve to create awareness
and stimulate interest. It cannot do the heavy lifting of
influence that is needed in any eye procedure that is paid
for directly by the patient. That duty is part of the broader
role that describes marketing.
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 145-149).
© 2019 SLACK Incorporated.
146  Chapter 15
FORCES INFLUENCING MARKETING
There are several main influences on the current state
of marketing for presbyopia, each of which has made it
more challenging for the practice to successfully attract and
treat patients. Let’s look at them one at a time.
History of Presbyopic Solutions
Treatment of presbyopia has been a work in progress
for more than 200 years, ever since Ben Franklin came up
with the first solution in the form of a bifocal lens. From
Revolutionary War times to present day, researchers, sci-
entists, and eye doctors have failed to come up with a com-
prehensive solution in the form of a treatment or procedure
that directly cures presbyopia. To date, the profession lacks
consensus as to the root cause of presbyopia and we are left
with several competing theories. In marketing terms, we do
not yet have any single product that works in the form of a
surgical solution. What is available today is a portfolio of
solutions ranging from appliances (spectacles and contacts)
to indirect alternatives (monovision) to implants (intraocu-
lar lenses and inlays). None of these, however, directly cure
or treat the condition. While numerous start-up companies
attempt to find a cure through a surgical solution, none
have yet emerged to achieve clinical as well as commercial
validation.
Low Consumer Awareness of Surgical
Solutions for Presbyopia
It is indeed rare that a medical condition would have
100% incidence in the target population; presbyopia meets
that definition. Ironically, most presbyopic patients have
no idea that surgical solutions exist. This is largely due to
their being invisible to the eye care system as currently
structured. A patient who has functioned as an emmetrope
all his or her life does not need to visit a doctor once his or
her lens fails to achieve full accommodation. The person
simply goes to the drugstore or online and orders a pair of
reading glasses. The cost is low enough that he or she can
afford to experiment and find what works for him or her. A
visit to a doctor is not required. Therefore, there is no ability
to inform and educate the patient to available alternatives.
Reaching this invisible audience will be covered later in this
chapter.
The Success of LASIK
LASIK has become the most widely performed elective
surgical procedure on the planet for one simple reason: it
works. The effectiveness of the procedure and its outstand-
ing safety profile have made it a viable alternative to spec-
tacle or contact lens dependent patients. Satisfaction sur-
veys put LASIK in the mid-90s (on a 100-point scale), and
patients anecdotally refer to LASIK as an investment in self
that has changed their lives for the better. The results are
immediate, the downtime is low, and the ability to enhance
an outcome is typically part of the consumer package.
One unintended consequence is that other eye proce-
dures have trouble competing in the patient’s mind with
the outstanding results achieved with LASIK. As pioneer-
ing cataract surgeon Sam Masket, MD, once told me, “My
cataract patients may not be willing to pay extra, but they
all expect LASIK-like results” (personal communication,
2008). This same sentiment may have doomed conductive
keratoplasty, whose results were less predictable, less stable,
and shorter lasting when compared to LASIK. Interestingly,
conductive keratoplasty patients did not compare their out-
comes to like alternatives, such as elimination of reading
glasses for some activities. Instead, LASIK became a catch-
all benchmark for consumers and remains so today.
The Unique Challenge of Marketing
Presbyopia Surgery to Presbyopes
Unlike LASIK and cataract patients, presbyopes are
not within the sphere of influence of eye care professionals
(ophthalmologists and optometrists), because they do not
typically seek treatment for that specific vision issue. As a
result, traditional approaches to marketing a new surgical
treatment to these current or potential patients have been
largely ineffective.
Clearly, innovative ideas are needed to market new
surgical treatments for presbyopia successfully. In order to
create new approaches, we must first identify the environ-
ment and media that influence presbyopes. Once these fac-
tors are determined, we can devise novel ways to motivate
these patients.
PLANO PRESBYOPES:
WHERE ARE THEY?
Although many presbyopes do not tend to visit eye
care professionals, they regularly shop for over-the-counter
reading glasses. As they get older, the power of the readers
must also be continually upgraded, and most presbyopes
own several pairs of readers. If a patient has significant
myopic or hyperopic refractive error, they must wear
glasses or contact lenses all the time and are used to having
glasses on their faces. In contrast, plano presbyopes do not
normally wear any type of glasses, so they often struggle
with having a pair of readers handy when they need them.
As a result, they tend to have a large quantity of reading
glasses throughout the house (eg, one of our patients had
19 pairs). Not only is this a significant inconvenience for
them, but it is also tremendously frustrating, since they are
constantly searching for their readers, and cannot seem to
find them when they need them the most.

Therefore, since the result is a frequent need to visit
stores and websites that sell over-the-counter readers,
such venues represent new opportunities to market the
latest presbyopia surgical treatments for these patients.
For example, print advertisements, educational kiosks, or
keywords can all be used to create awareness that options
for treatment exist, providing a call to action to come in for
evaluation by a specialist. These can be placed at strategic
locations in stores and on website search results where
presbyopic patients typically shop for reading glasses. The
content does not need to be overly complex: videos can con-
vey the happiness that presbyopia surgery patients similar
to themselves are experiencing, depicting them as free of
their dependence on readers, having eliminated an irritat-
ing nuisance, and reinforcing the self-perception of feeling
and looking younger.
While it is true that marketing new treatments to
presbyopes presents an unprecedented challenge to us as
ophthalmologists and optometrists, since these patients
have not traditionally been under our sphere of influence,
the unblazed trail of marketing to such a significant patient
population also presents a tremendous and exciting oppor-
tunity for innovators who are willing to invest in educating
presbyopes where they live.
THE GOAL OF
PRESBYOPIC MARKETING
As a condition, presbyopia needs to be viewed
180 degrees opposite from how every other condition of
the eye is discussed in an ophthalmic practice. At the core
of the typical doctor-patient interaction, the process goes
something like this. Patient will present with a complaint,
receive a diagnosis, and be provided a solution, typically in
the form of a procedure or a prescription. Patient returns to
the practice at some future date for further evaluation. This
process can be described as procedure-centric or proce-
dure-focused. Although it does begin with understanding
of a patient’s condition, the entire ophthalmic profession
has been geared around the solutions to those conditions,
beginning with how we categorize and delineate subspe-
cialties. We have cataract surgeons, LASIK practices, and
dry eye clinics. The ophthalmic profession has evolved
around diagnosis and treatment of specific conditions.
Like it or not, the practice is organized around one or more
procedures.
Presbyopia is sufficiently different in that it requires a
unique approach, which we describe as “start with patient.”
(Note: We considered using “patient first,” but that phrase
does not create a sufficient distinction as it closely resem-
bles the main intent of the Hippocratic Oath.) By starting
with the patient, you organize your presbyopic marketing
efforts around the patient instead of around the procedure.
The goal of presbyopic marketing cannot use the same
Marketing Surgical Treatment for Presbyopia   147
metrics as cataract or LASIK, such as number of cases per-
formed, percentage of patients who move forward with a
procedure, or ability to upgrade the instrumentation used
during the procedure.
Presbyopic marketing needs to stay focused on the
issue itself and the pain points it creates in the lives of just
about everyone over the age of 50 years. Given the fact that
one-half of your local adult population has likely never
been to an eye doctor, there is a huge opportunity to stake
out a position as a presbyopic specialist. In this context,
your training, skill, and experience in dealing with medi-
cal conditions of the eye allows you to make that claim, if
you choose to start with patient and resist the temptation to
market a specific procedure. Your competition in this con-
text is the rack of readers at the drugstore. That is typically
the first go-to option for most patients when they become
sufficiently frustrated at their ability to read up close. Your
goal in marketing is to create awareness that a special-
ist exists who can help a person deal with this newfound
frustration.
THE THREE KEY QUESTIONS
Recognizing that developing a presbyopic practice
within your practice requires a different type of commu-
nication skill that begins with developing your own set of
answers to the following 3 questions:
1. Who are they?
2. What do they need?
3. How can they be influenced?
One of the key observations over the years has been
that doctors are very good at talking “tech” yet struggle
to communicate in ways that patients understand and feel
heard. This is most evident in self-pay procedures includ-
ing LASIK and refractive cataract surgery but extends to
all parts of the patient-doctor interaction. A serious look
at these 3 questions forces the doctor to examine what
is truly important to the patient (start with patient). We
recommend thinking about these questions on 2 levels.
First, apply them to the presbyopic population as a whole.
Working with your staff, develop a shared understanding
of what life is like for the presbyope. Your team will be able
to look at this from their perspective as a medical practice
and as someone who either is presbyopic or has family and
friends who are. Here are some additional questions to
guide the discussion:
▶ What do we hear from patients who are suffering
from near vision issues?
▶ What would happen if we invested time to listen
to their concerns?
▶ How can we utilize their frustration to gain greater
understanding and cooperation with their eye care
overall?
148  Chapter 15

TABLE 15-1
QUESTIONS TO HELP DEVELOP A PRESBYOPIC STRATEGY
UNDERSTANDING THE TARGET AUDIENCE AND HOW TO
COMMUNICATE WITH THEM AT KEY TOUCHPOINTS
Presbyopic Population (Group)
Touchpoint Virtual (internet)
Medium Social marketing (social media)
Goal Create awareness and interest in a way
that begins and builds a relationship
Key questions practice must answer Who are they?
What do they need?
How can they be influenced?
Presbyopic Patient (Individual)
Physical (in person)
Consultation
Provide personalized education and
stimulate action
Why specifically are you here today?
What are your lifestyle goals that are
impacted by vision?
What type of education or support do
you need to make a decision?

Presbyopia can serve as a gateway to build upon an

existing patient relationship as well as cultivate new ones.
Second, those same 3 questions can be modified to
apply to each interaction you have with a presbyopic patient.
Asking them in some form as part of the interaction with a
patient tends to upgrade the discussion into a conversation.
Practices we (SM2 Strategic) have worked with incorporate
the understanding of individual goals as a critical part of
the discovery process and a far cry from a simple intake
of history.2 By making sure any and all recommendations
are based on the patient’s individual goals for his or her
vision, you will find that patients are far more receptive
to the recommendation, willing to pay for it, and commit-
ted to doing their part to achieve the desired outcome. We
observe this especially in the discussions around what to
do about a cataract; when the thrust of the conversation is
about lifestyle goals rather than reimbursement coverage,
the tenor suggests a different level of interest on the part of
the physician and staff. The 3 key questions rewritten for
use in an individual encounter would be:
1. Why specifically are you here today?
2. What are your lifestyle goals that are impacted by
vision?
3. What type of education or support do you need to
make a decision?
You may be surprised to find that the assumptions you
had about a particular patient are not evident once a discus-
sion takes place. This is especially true once you shift your
thinking about presbyopia from start with procedure to start
with patient. Table 15-1 reviews this communication plan.
SOCIAL MARKETING
The challenge becomes how to reach these invisible
patients with sufficient frequency such that they are moti-
vated to take action. Reach and frequency are terms used in
defining the cost and impact of advertising. The good news
is that advertising is too expensive and too interruptive
in most forms to be effective for reaching the presbyopic
patient. The better news is that social media provides the
platform for you and your practice to engage in a relation-
ship that, over time, builds trust and confidence so that the
patient picks up the phone to make an appointment instead
of picking up a new and slightly stronger pair of readers at
the store. Unlike advertising, which is basically interruptive
marketing, a program that invests time and resources in
social media should be viewed as social marketing. It fol-
lows some of the same rules, but the outcome is different.
With advertising, you are typically striving to get someone
to respond to an offer (call to action) and contact the prac-
tice. This is how most practices measure the effectiveness
of the money spent on paid promotion. With social media,
an entirely different set of criteria affect its effectiveness.
Content is key. If what you are saying fails to be relevant to
the audience, it will be ignored. Consistency is important.
A one-time or occasional blog will not develop a following.
Communication basics are also vital, as social implies a
relationship. Meaningful relationships are built over time
and require a more thoughtful and long-term view. Out
of those relationships comes trust. And from trust comes
action at the right time.

In contrast to advertising and a required budget of
money, social marketing requires time. Time is needed to
write and post content. Time is needed to cultivate a follow-
ing of readers across the various platforms. Time is needed
to respond to specific inquiries and questions, most of which
will not result in a booked appointment. Time is the price
that you must pay if you want to play in the social market-
ing arena. For presbyopia, it is the best means of establishing
awareness of your role as a specialist in this area.
Admittedly, it is a long-term approach. But given the
state-of-the-art technology to treat presbyopia, that long-
term approach is warranted. As stated earlier, presbyopic
procedures are a work in progress and will continue to
evolve. They are similar in concept to what consumers
experience with electronics. The technology continues to
get better over time, but that does not stop consumers from
buying electronics. There is an inherent understanding that
what is available tomorrow may well be better than what
is available today. Our recommendation is that surgeons
embrace this reality rather than sit on the sidelines and
shrug their shoulders when it comes to offering presbyopic
solutions to their patients.
CONCLUSION
Treatment of presbyopia is the most challenging medical
procedure in ophthalmology, not because of the technique
but rather because of the human psychology involved. In our
midst is a population with nearly 100% incidence and low
awareness of current solutions, however imperfect.3 It is this
Marketing Surgical Treatment for Presbyopia   149
holding out for a perfect solution, which likely will never
exist, that prevents eye specialists from taking a more active
role in educating patients on presbyopia. What results is a
self-fulfilling prophecy where patients are largely stuck with
reading glasses and doctors fail to capitalize on available
solutions that will undoubtedly improve over time.
The best way to change this worldview begins in one’s
own practice. Take the presbyopic condition more seriously
by beginning to view the problem from the perspective of
the patient and the effect on his or her life. Because vision
is treated as the most important of the senses, ophthalmol-
ogy is blessed by having identified 2 conditions that serve as
landmarks in the vision and life of a patient: presbyopia and
cataract.4 Presbyopia signifies “I’m getting old” while diag-
nosis of cataract signals “I’m old.” In today’s society and its
obsession with youth, you play an important role in helping
retain function in both of these aging processes. Becoming
presbyopic should be viewed as the greatest opportunity
available to the eye specialist in terms of developing solu-
tions that fit the lifestyle needs of each patient. Many
options and procedures exist and many more will come, but
always remember to start with patient.
REFERENCES
1. 2017 Report on Presbyopia, Market Scope, Inc. St. Louis, MO
2. Mahdavi S. A marketing plan that hinges on listening: the most
effective tool for premium IOL conversion is looking at you in the
mirror. Ophthalmology Management. 2017;21:64, 66, 74.
3. VTI Data on file, 2017.
4. AOAMF Global Multifocal Penetration/Market Assessment study
on US, Germany, Japan markets, March 2011.

Future of
Presbyopia Treatment
Ming Wang, MD, PhD and Nathan Rock, OD, FAAO
Modern refractive surgeons are challenged by patients
who wish to be free of glasses at all distances. All current
surgical options for presbyopia present some form of limita-
tion or compromise, such as poor intermediate vision, com-
promise to distance vision, or part-time need for glasses. No
options currently available actually attempt to treat presby-
opia as a disease and directly reverse the accommodative
loss. Future developments in surgical presbyopia correction
are aimed at reducing these compromises.
Since presbyopia is a lens-based problem, it is not
surprising that the majority of future developments are
focused on intraocular solutions. Many view the ideal
intraocular lens (IOL) as the optimal treatment for presby-
opia. However, as existing corneal options are optimized
and new options are approved, they will continue to have
a significant role. As scleral treatment options may reach
approval in the United States, interest in these techniques
will also likely increase.
ADJUSTABLE INTRAOCULAR LENSES
One of the major barriers associated with current IOL
technology is management of residual refractive error.
This is particularly challenging for presbyopia-correcting
IOLs because small refractive errors can make significant
- 151 -
16
differences in uncorrected vision at distance, near, or both.1
Typically, residual refractive errors are currently surgically
corrected with keratorefractive procedures such as LASIK,
photorefractive keratectomy (PRK), or astigmatic kera-
totomy. While effective, corneal procedures may signifi-
cantly exacerbate dry eye in eyes having recently undergone
phacoemulsification in an older population already at risk
for poor ocular surface health.
Residual refractive error is more problematic in patients
with prior PRK, LASIK, and radial keratotomy, where the
corneal power is unnatural. Modern fourth-generation IOL
formulas that factor in multiple variables such as Haigis
(which factors in anterior chamber depth) and Holladay
2 (using white-to-white, the lens thickness, the refraction,
and age) have been helpful for improved outcomes in these
groups.2 However, disagreement in predictive IOL power
of different formulas may result in residual refractive error
in prior refractive surgery patients.3 More post–refractive
surgery patients are developing dysfunctional lens syn-
drome or visually significant cataracts and pursuing lens
replacement. Unfortunately, this group often has the most
demanding visual expectations. Residual refractive errors
treated with additional corneal refractive enhancements
may be less predictable. They may also lead to undesirable
postoperative complications, such as haze with PRK and
epithelial ingrowth or other flap complications after a flap-
based treatment.
Wang M, ed.
Surgical Correction of Presbyopia: The Fifth Wave (pp 151-157).
© 2019 SLACK Incorporated.
152  Chapter 16
Figure 16-1. The light-adjustable IOL (RxLAL). (Reprinted with
permission from RxSight.)
For this reason, postoperatively adjustable IOLs are
appealing. To be successful, several properties are neces-
sary. The lens would need to be biocompatible with ocular
tissues. It would need to be safely adjustable to reliably
correct myopic, hyperopic, and astigmatic refractive errors
to within 0.25 to 0.5 diopters (D) of the target. The ideal
adjustable IOL would utilize a noninvasive adjustment that
did not require entering the anterior segment or taking the
patient to the operating room. Proposed solutions include
the use of multiple lens components, magnets, liquid crys-
tals, femtosecond lasers, and ultraviolet light. IOLs have
been proposed and patented using these technologies,
although most have not reached the stage of human use.4
The first adjustable IOL was approved in the Fall of 2017 by
the US Food and Drug Administration (FDA).5
The Acri.Tec AR-1 posterior chamber IOL is a mechan-
ically adjustable IOL that has been tested in human sub-
jects. The IOL contains a piston attached at the optic-haptic
junction. The surgeon alters the refractive power of the IOL
by moving the piston relative to the cylinder. This adjust-
ment is done through 2 small corneal paracenteses via a
manipulator allowing for approximately 2.0 D of power
change. The lens has been shown to be safe and adjustments
have shown refractive stability without complication for as
long as 18 months postoperatively. The disadvantage of this
lens type and design is the need for an invasive, though
minimal, adjustment in an operating room setting, which
limits its future potential. However, it clearly demonstrated
the efficacy of an adjustable lens in a clinical setting.6
The light-adjustable IOL (RxLAL [RxSight]; Figure
16-1) has been available in Europe and Mexico since 2008,
and the monofocal was approved by the FDA in the Fall
of 2017 but has not yet seen widespread use. The 3-piece
monofocal IOL is composed of silicone with an optic con-
taining a light-activated photoinitiator and mobile silicone
macromers. When exposed to spatially profiled ultraviolet
light, the photoinitiator causes a macromer to polymerize.
The exposure to treated regions of the lens causes a precise
shape change inducing a power change. The adjustment
range is up to 2.0 D for hyperopia, myopia, and astigma-
tism. Adjustments are typically needed in 1 to 2 sessions of
less than 2 minutes with a final application to lock in the
correction. The adjustment is performed with a slit lamp–
mounted light delivery device linked to a computer, which
programs the appropriate intensity and duration of light.
Several clinical trials have shown effective and safe results
of the monofocal RxLAL with precise adjustments.7
For presbyopia, one appealing option of this IOL
would be the possibility of “optimized monovision” which
does not have to be fully determined preoperatively. For
instance, the dominant eye can be targeted plano and the
nondominant eye to -1.0 D. After the surgery, if a patient
desires to have adjustment to the intended monovision
distance, such as closer in, the power of the IOL could be
changed as needed. In the future, it is possible that the light
adjustment could be used for customization of a multifocal
intraocular lens which could help to alleviate the difficulty
associated with residual refractive error with these IOLs. A
major benefit of this technology versus enhancement with
corneal refractive surgery is being able to make the adjust-
ment within days to weeks after the surgery versus waiting
3 months for LASIK or PRK. This lens adjustment could
also reduce the additional difficulty of a corneal enhance-
ment for patients with a history of prior refractive surgery.5
MULTIFOCAL INTRAOCULAR LENSES
Current multifocal lenses, including recently intro-
duced toric options, provide impressive distance and read-
ing vision but are not free of compromise. The rings in mul-
tifocal lenses can result in undesirable visual effects such
as halos, glare, starbursts, and loss of contrast.1 Current
diffractive bifocal add powers do result in compromise to
reading ability at certain distances. The higher power add
models provide excellent near vision but with a loss of inter-
mediate vision. The lower add power models provide great
intermediate vision but a loss of clarity at near, with more
dependence on part-time readers.
Trifocal diffractive IOLs attempt to address these limi-
tations by adding an additional focal point for intermediate
vision. Three major trifocal IOLs are available interna-
tionally, which include the AT LISA trifocal (Carl Zeiss
Meditec; Figure 16-2), FineVision trifocal (PhysIOL; Figure
16-3), and AcrySof IQ PanOptix (Alcon Laboratories, Inc).
These lenses are currently under investigation by the FDA.
While very promising, they do have similar limitations
to bifocal diffractive multifocal lenses including the need
for careful patient selection and visual side effects, such as
halos.8,9
The lenses themselves are designed with 2 repeating
steps of intermediate and near focal points between flat
steps for distance. The AT LISA trifocal and FineVision

Figure 16-2. The AT LISA trifocal IOL. This IOL is not available for
sale in the United States. (Reprinted with permission from Carl
Zeiss Meditec.)
IOLs distribute light equally between distance, intermedi-
ate, and near, each with a third of the share. The interme-
diate focal point for these IOLs is set at 80 cm or approxi-
mately 30 inches. The AcrySof IQ PanOptix dedicates 50%
to distance, 25% to intermediate, and 25% to near. The
intermediate focal point is 60 cm or about 24 inches.10
PHAKIC INTRAOCULAR LENSES
Phakic correction of presbyopia does provide the
advantage of preserving existing accommodative func-
tion for those without significant lens opacity. Existing
monofocal phakic IOLs for myopic correction have demon-
strated excellent optical quality and fast vision recovery.11
The Presbyopia Implantable Phakic Contact Lens (IPCL
Presbyopic; Care Group) is a diffractive multifocal lens
made of hydrophilic acrylic. The lens allows for correction
of myopia, hyperopia, and astigmatism from between +10.0
D to -25.0 D along with near additions between +1.5 D and
+3.5 D. Long-term outcomes still need to be completed to
assess the safety and efficacy of this lens.11 Another pha-
kic implantable collamer lens (ICL), the Presbyopic EVO+
Visian ICL (STARR Surgical), designed for the correction
or reduction of presbyopia, has recently entered clinical tri-
als. This design is based off of the EVO+ Visian ICL which
obtained CE mark in 2017 for correction of a range from
+3.0 D to -18.0 D for patients 21 to 45 years old.12
SMALL-APERTURE
INTRAOCULAR LENSES
The IC-8 IOL (AcuFocus, Inc; Figure 16-4) is a 1-piece
acrylic IOL with an embedded black circular mask with
a central 1.36-mm aperture. The aperture extends depth
of focus in the same manner as the KAMRA corne-
al inlay (CorneaGen), by blocking unfocused light rays.
Future of Presbyopia Treatment   153
Figure 16-3. The FineVision Trifocal Optic IOL. (Reprinted with
permission from PhysIOL.)
Figure 16-4. The AcuFocus, Inc IC-8 IOL. (Reprinted with permis-
sion from AcuFocus, Inc.)
It is implanted in the less dominant eye and can provide
an average of J1 (Jaeger) at near and 20/20 at intermediate
at distance. An advantage of the extended depth of focus
provided by the aperture is that it is much more tolerant
to residual refractive error, particularly for astigmatism,
than a multifocal lens implant. Visual symptoms of glare
and halo are reported but generally rated as less severe than
a multifocal lens implant. The lens is approved for use in
Europe but is not yet in clinical trials in the United States.13
TRUE ACCOMMODATING
INTRAOCULAR LENSES
The ideal solution for presbyopia is a lens implant
that would mimic the natural accommodation capability
of the crystalline lens. Feasible options that could achieve
this could involve IOLs that change shape or position in
response to movement of the lens capsule or the ciliary
body, electronic implants, and crystalline lens refilling.14
The hinged plate haptic IOL Crystalens (Bausch + Lomb)
does have the labeling for accommodation; however, the
typical amount of accommodation is lower than desired.
The mechanism of action of the Crystalens has not been
154  Chapter 16
Figure 16-5. The FluidVision IOL. (Reprinted with permission
from PowerVision.)
definitively linked to movement in the capsular bag.15
Other internationally available single-optic lenses similar
to the Crystalens such as the 1CU (HumanOptics AG) have
similar limitations.14
There are several lenses under investigation that are
designed to provide greater accommodative ability using
lens movement or shape change in response to the capsu-
lar bag. The FluidVision IOL (PowerVision; Figure 16-5)
is an acrylic implant filled with silicone oil that changes
curvature with response to accommodation. The lens is
implanted in the lens capsule and movement of the ciliary
muscle squeezes fluid from the haptics into the optic. The
lens has entered clinical trials outside of the United States
and initial results of this lens are promising. A preliminary
trial of 26 patients indicates approximately 3.0 D of accom-
modative effect and contrast sensitivity equal to that of
a monofocal lens, exceeding multifocal performance in
this area.16 Other lenses in this category at earlier stages
in development include the Wichterle Intraocular Lens-
Continuous Focus (WIOL-CF; Medicem) and the Juvene
accommodating IOL (LensGen).17
Lenses implanted in the sulcus offer an alternative solu-
tion. Because of the implant’s location, it avoids challenges
such as capsular fibrosis and atrophy, which may inhibit
accommodation. The Lumina (AkkoLens International;
Figure 16-6) is a dual-optic lens that has 2 parallel optics
separated by a small space. The lens functions by changing
power as the optics adjust position relative to one another
in response to the ciliary body. Another investigational
Figure 16-6. The Lumina IOL. (Reprinted with permission from
AkkoLens International.)
sulcus-implanted dual-optic lens is the NuLens DynaCurve
(NuLens Ltd), in which the lens optics change curvature
with response to the ciliary body.17
ELECTRONIC IMPLANTS
An electronic implant removes the barrier of the lens
movement, which can be inhibited by capsular fibrosis. One
such proposed lens is the Sapphire AutoFocal IOL (Elenza),
a monofocal aspheric IOL with an electroactive liquid
crystal optic. The lens contains photosensors that monitor
a patient’s pupillary movement associated with accommo-
dation. A processor would recognize the pupil size relative
to illumination and provide accommodative change. Small
solid-state rechargeable power cells activate the liquid crys-
tal optic. The lens has capability of 2-way communication
to interact with the fellow eye and an outside interface. The
lens will require recharging, which can be performed at a
distance of up to 20 cm and so could be done via a sleep
mask, pillow, or neck pillow. The lens is designed to default
to a monofocal IOL setting should electronics fail. The lens
is designed to provide 3.0 D of functional near vision add.18
Other proposed electronic implants respond to stimulus of
electronic impulses in the ciliary muscle, or with pressure
sensors that respond to changes in the ciliary muscle and
capsule. A barrier of this modality may be patient accep-
tance of having an electronic implant.19

CRYSTALLINE LENS REFILLING
Crystalline lens refilling with a flexible, injectable
material within an intact capsule, normal zonular integrity,
and ciliary muscle function would present an attractive
solution for surgical correction of presbyopia. Several bar-
riers to this technique must be overcome, including leakage
of material from the capsule, capsular fibrosis and opacifi-
cation, and residual refractive error. Several possible solu-
tions have been proposed, including the use of a very small
capsulorrhexis, filling the capsule with a polymer of differ-
ent refractive indices, and closing it with a plug.20 Another
option includes performing standard phacoemulsification
with a small anterior and posterior capsulorrhexis. Two
IOLs are then placed in the capsular bag, one at the anterior
and one at the posterior surface. The capsule is then filled
with a polymer. It is still unknown if the ciliary muscle in
the aged eye would provide sufficient accommodative func-
tion.20 Recent research in monkey eyes seems to confirm
that accommodative amplitude can be maintained, but
many barriers still remain before this is applied in a clinical
trial setting.21
Future of Presbyopia Treatment   155
Table 16-1 lists current IOL options for the surgical
management of dysfunctional lens syndrome and their
approval status in the United States and Europe.
CONCLUSION
Surgical correction of presbyopia has advanced expo-
nentially in the past decade. Corneal surgical treatments,
including the recently approved corneal inlays, have pro-
vided a new avenue for a challenging patient population.
Scleral treatments may soon gain approval in the United
States, and this is an exciting bilateral modality. Our cur-
rent lens options have already improved drastically, and
this area may present the most promising growth for
the future. It will be exciting to participate in the care of
patients as the technology for presbyopia treatment contin-
ues to evolve and improve.
156  Chapter 16

TABLE 16-1
PRESBYOPIA-CORRECTING INTRAOCULAR LENSES
Lens Name Company Lens Type Approval Status
With FDA and CE
TECNIS 1-piece Johnson & Johnson Vision; Alcon Monofocal ☑ FDA
(ZCBOO); AcrySof IQ Laboratories, Inc; Bausch + Lomb ☑ CE mark
(SN60WF); enVista; Toric
IOLs
Crystalens Bausch + Lomb Accommodating, single optic ☑ FDA
☑ CE mark
1CU HumanOptics AG Accommodating, single optic ☐ FDA
☑ CE mark
Trulign Bausch + Lomb Toric, monofocal, accommodating ☑ FDA
☑ CE mark
FluidVision PowerVision Accommodating ☐ FDA
☑ CE mark
Sapphire AutoFocal Elenza Electronic accommodating ☐ FDA
☐ CE mark
NuLens DynaCurve NuLens Ltd Dual-optic accommodating ☐ FDA
☐ CE mark
Lumina AkkoLens International Dual-optic accommodating ☐ FDA
☐ CE mark
SmartIOL Medennium Accommodating ☐ FDA
☐ CE mark
Tek-Clear Tekia Accommodating ☐ FDA
☑ CE mark
Tetraflex Lenstec Accommodating ☐ FDA
☑ CE mark
TECNIS Multifocal Johnson & Johnson Vision Multifocal, diffractive aspheric ☑ FDA
☑ CE mark
AcrySof IQ ReSTOR Alcon Laboratories, Inc Multifocal, apodized diffractive ☑ FDA
☑ CE mark
ReZoom Abbott Medical Optics, now Multifocal ☑ FDA
Johnson & Johnson Vision ☑ CE mark
LENTIS Mplus Oculentis Multifocal, rotationally ☐ FDA
asymmetric, bifocal and trifocal ☑ CE mark
FineVision PhysIOL Multifocal, rotationally symmetric, ☐ FDA
bifocal and trifocal ☑ CE mark
AT LISA Carl Zeiss Meditec Multifocal, rotationally symmetric, ☐ FDA
bifocal and trifocal ☑ CE mark
AcrySof IQ PanOptix Alcon Laboratories, Inc Trifocal ☐ FDA
Toric ☑ CE mark
TECNIS Symfony and Johnson & Johnson Vision Extended depth of focus ☐ FDA
Symfony Toric ☑ CE mark
Light Adjustable (RxLAL) RxSight Light-adjustable monofocal ☑ FDA
☑ CE mark
IC-8 AcuFocus, Inc Small-aperture IOL ☐ FDA
☑ CE mark

(continued)
 Future of Presbyopia Treatment   157

TABLE 16-1 (CONTINUED)

PRESBYOPIA-CORRECTING INTRAOCULAR LENSES
Lens Name Company Lens Type Approval Status
With FDA and CE
Perfect Lens Perfect Lens, LLC Femtosecond laser adjustable ☐ FDA
☐ CE mark
Clarvista Harmoni Clarvista Medical Multicomponent ☐ FDA
Modular IOL ☑ CE mark
Omega Lens Omega Ophthalmics Multicomponent ☐ FDA
☐ CE mark
Infinite Vision Infinite Vision Optics Multicomponent ☐ FDA
☐ CE mark
Acri.Tec AR-1 Acri.Tec, now Carl Mechanically adjustable ☐ FDA
Zeiss Meditec ☐ CE mark
Eggleston Adjustable University of Magnetically adjustable ☐ FDA
Lens Missouri-Rolla ☐ CE mark

12. Densford F. Staar Surgical wins CE Mark for EVO+ Visian ICL,
REFERENCES readies presbyopia study. Mass Device. https://www.massdevice.
com/staar-surgical-wins-ce-mark-evo-visian-icl-readies-presbyo-
1. Gundersen KG, Makari S, Ostenstad S, Potvin R. Retreatments
pia-study/. Published May 11, 2017. Accessed June 6, 2018.
after multifocal intraocular lens implantation: an analysis. Clin
13. Dick HB. Best kept secrets: IC-8. Cataract Refract Sugery Today Eur.
Ophthalmol. 2016;10:365-371. doi:10.2147/OPTH.S100840.
2017;Jan:48-49.
2. Devgan U. Which IOL formula should be used for which eyes?
14. Lindstrom RL. Medical and surgical innovations expected to trans-
Ocular Surgery News. May 25, 2014. https://www.healio.com/
form treatment of presbyopia. Ocular Surgery News. https://www.
ophthalmolog y/cataract-surgery/news/print/ocular-surgery-
healio.com/ophthalmology/refractive-surgery/news/print/ocular-
news/%7Bbf57b195-d532-46da-95f4-c2019665237f%7D/which-iol-
surgery-news/%7B1a1d6e7c-3186-4f1f-9dfd-04ed28441c78%7D/
formula-should-be-used-for-which-eyes. Accessed June 6, 2018.
medical-and-surgical-innovations-expected-to-transform-treat-
3. Hodge C, McAlinden C, Lawless M, Chan C, Sutton G, Martin A.
ment-of-presbyopia. Published April 25, 2017. Accessed July 20,
Intraocular lens power calculation following laser refractive sur-
2018.
gery. Eye Vis (Lon). 2015;2:7. doi:10.1186/s40662-015-0017-3.
15. Dhital A, Spalton DJ, Gala KB. Comparison of near vision, intra-
4. Ford J, Werner L, Mamalis N. Adjustable intraocular lens power
ocular lens movement, and depth of focus with accommodat-
technology. J Cataract Refract Surg. 2014;40(7):1205-1223.
ing and monofocal intraocular lenses. J Cataract Refract Surg.
doi:10.1016/j.jcrs.2014.05.005.
2013;39(12):1872-1878. doi:10.1016/j.jcrs.2013.05.049.
5. Bethke W. RxLAL: Say Goodbye to Postop Surprise? Review of
16. Potgieter F. Two years of follow-up with FluidVision IOL show
Ophthalmology. https://www.reviewofophthalmology.com/article/
promising results. Ocular Surgery News. https://www.healio.com/
rxlal-say-goodbye-to-postop-surprise. Published January 10, 2018.
ophthalmology/refractive-surgery/news/online/%7Bab9a4ae1-
Accessed July 20, 2018.
4951-4145-a82e-7c0af23a92c5%7D/two-years-of-follow-up-with-
6. Jahn CE, Schopfer DC. Cataract surgery with implantation of
fluidvision-iol-show-promising-results. Published September 11,
a mechanically and reversibly adjustable intraocular lens. Arch
2015. Accessed July 20, 2018.
Ophthalmol. 2007;125(7):936-939. doi:10.1001/archopht.125.7.936.
17. Saraiva J, Neatrour K, Waring G. Emerging technology in
7. Villegas EA, Alcon E, Rubio E, Marin JM, Artal P. Refractive accu-
refractive cataract surgery. J Ophthalmol. 2016;2016: 7309283.
racy with light-adjustable intraocular lenses. J Cataract Refract Surg.
doi:10.1155/2016/7309283.
2014;40(7):1075-1084.e2. doi:10.1016/j.jcrs.2013.10.046.
18. Donnenfeld ED. An “autofocal” accommodating IOL. Cataract &
8. Gunderson K, Potvin R. Trifocal intraocular lenses: a comparison of
Refractive Sugery Today. https://crstoday.com/articles/2013-jun/
the visual performance and quality of vision provided by two differ-
an-autofocal-accommodating-iol/. Published June 2013. Accessed
ent lens designs. Clin Ophthalmol. 2017;11:1081-1087.
June 6, 2018.
9. Mendicute J, Kapp A, Pierre L, et al. Evaluation of visual outcomes
19. Pepose JS, Burke JS, Qazi MA. Accommodating intraocular lenses.
and patient satisfaction after implantation of a diffractive trifo-
Asia Pac J Ophthalmol (Phila). 2017;6(4):350-357. doi:10.22608/
cal intraocular lens. J Cataract Refract Surg. 2016;42(2):203-210.
APO.2017198.
doi:10.1016/j.jcrs.2015.11.037.
20. Nishi Y, Mireskandari K, Khaw P. Lens refilling to restore accom-
10. Bethke W. Bringing things into (tri)focus. Review of Ophthalmology.
modation. J Cataract Refract Surg. 2009;35(2):374-382. doi:10.1016/j.
https://www.reviewofophthalmology.com/article/bringing-things-
jcrs.2008.10.054.
into-trifocus. Published May 10, 2017. Accessed June 6, 2018.
21. Nishi O, Nishi Y, Chang S, Nishi K. Accommodation ampli-
11. Pineda R, Chauhan T. Phakic intraocular lenses and their spe-
tudes after an accommodating intraocular lens refilling proce-
cial indications. J Ophthalmic Vis Res. 2016;11(4):422-428.
dure: in vivo update. J Cataract Refract Surg. 2014;40(2):295-305.
doi:10.4103/2008-322X.194140.
doi:10.1016/j.jcrs.2013.06.028.
 Financial Disclosures

Dr. Amar Agarwal is a consultant/advisor to STAAR Surgical and Sanoculus; he receives grant support from
Bausch + Lomb; and has patents with Mastel.
Dr. Jay Bansal has no financial or proprietary interest in the materials presented herein.
Dr. Y. Ralph Chu is a primary investigator and consultant for ReVision Optics and Refocus Group.
Dr. Paul J. Dougherty is a consultant for STAAR Surgical, Nidek Inc, Stroma Medical, and Lenstec; and has equity in
Stroma Medical and Lenstec.
Dr. Michael Duplessie has no financial or proprietary interest in the materials presented herein.
Dr. Michael Endl has no financial or proprietary interest in the materials presented herein.
Dr. David I. Geffen is a consultant to Alcon Laboratories, Inc, Johnson & Johnson Surgical, and Valent Pharmaceutical.
Dr. Arun C. Gulani has no financial or proprietary interest in the materials presented herein.
Dr. Brad Hall is a consultant for Ace Vision Group.
Dr. Jessica Heckman has no financial or proprietary interest in the materials presented herein.
Dr. AnnMarie Hipsley is an employee of Ace Vision Group.
Dr. Soosan Jacob has no financial or proprietary interest in the materials presented herein.
Dr. Li Jiang has no financial or proprietary interest in the material presented herein.
Dr. Robert M. Kershner has no financial or proprietary interest in the material presented herein.
Dr. Terry Kim is a consultant for Aerie Pharmaceuticals, Alcon Laboratories, Inc/Novartis, Allergan/Actavis,
Avedro, Avellino Labs, Bausch + Lomb/Valeant, Blephex, CoDa/Ocunexus Therapeutics, Kala Pharmaceuticals, NovaBay
Pharmaceuticals, Ocular Therapeutix, Omeros, Powervision, Presbyopia Therapies, Shire, Sightlife Surgical Inc, Simple
Contacts, TearLab, and TearScience; and has ownership of Kala Pharmaceuticals, NovaBay Pharmaceuticals, Ocular
Therapeutix, Omeros, Sightlife Surgical Inc, Simple Contacts, and TearScience.
Dr. David H. K. Ma has no financial or proprietary interest in the materials presented herein.
Mr. Shareef Mahdavi has no financial or proprietary interest in the materials presented herein.

- 159 -
160  Financial Disclosures

Dr. Lisa Martén has no financial or proprietary interest in the materials presented herein.
Dr. Kristin Neatrour has no financial or proprietary interest in the materials presented herein.
Dr. Samuel Passi has no financial or proprietary interest in the materials presented herein.
Dr. Jay S. Pepose is a consultant for AcuFocus, Inc.
Dr. Mujtaba A. Qazi has no financial or proprietary interest in the materials presented herein.
Dr. Karolinne M. Rocha has no financial or proprietary interest in the material presented herein.
Dr. Amanda J. Setto has no financial or proprietary interest in the materials presented herein.
Dr. Lisa Sitterson has no financial or proprietary interest in the materials presented herein.
Dr. Barrie Soloway is the Medical Director of Refocus Group.
Dr. Tracy Schroeder Swartz has no financial or proprietary interest in the materials presented herein.
Dr. Atalie C. Thompson has no financial or proprietary interest in the materials presented herein.
Dr. David Varssano has no financial or proprietary interest in the materials presented herein.
Dr. Ming Wang has no financial or proprietary interest in the materials presented herein.
Dr. George Waring IV is a consultant for Johnson & Johnson Vision, Alcon Laboratories, Inc, Bausch + Lomb, Allergan,
Visiometrics, Oculus, Avedro, Perfect Lens, LLC, and Ace Vision.
Dr. Monica Youcefi has no financial or proprietary interest in the materials presented herein.