Documente Academic
Documente Profesional
Documente Cultură
After years of dealing with the hassle Before surgery, patients are typically
of spectacles and contact lenses, you’ve told that the risk of complications from
decided to reward yourself by having Lasik is 1%, and even lower in the hands
Lasik. You’ve read the glowing reports of an experienced surgeon (such as the
in the media about the wonders of this one trying to sell you the procedure).
“state of the art” procedure and your For starters, you must realize that the
ophthalmologist has just pronounced you risk being referred to is for each eye, so
“a perfect candidate.” the combined risk that permanent
It is at this time, more than at any damage will occur to at least one eye is,
other time in your life, that you must by these figures, actually 2%. Doesn’t
pause, stand back from the excitement of sound so good anymore? Read on…
the moment, and reflect deeply on what During the process of obtaining Food
you are about to do. Lasik will and Drug Administration (FDA)
permanently alter the optics and Preliminary Market Approval (PMA) for
physiology of your eyes. Most likely its LADARVision Excimer Laser
things will go well. But there is a System, Alcon Corporation admitted that
significant chance, much greater than 22.8% of Lasik patients complained of
many ophthalmologists realize or will light sensitivity post-operatively, 7.1%
publicly admit, that your eyes will be now suffered from headaches, 31.9%
irreversibly damaged. The results could had glare symptoms, and 32% now
be devastating. experienced night driving difficulties.1
When considering elective surgery The FDA nevertheless approved the
one must ask if the benefits truly LADARVision laser for commercial
outweigh the risks involved. You’ve use,2 despite the fact that 12.7% of
heard a lot about the benefits, no doubt LADARVision patients stated that they
from the surgeon who stands to gain experienced “worse” or “significantly
financially by operating on your eyes. worse” quality of vision, as reported in
But you owe it to yourself to take a few the PMA.3
minutes to read the rest of this document Another study states that
in order to become better informed about complications from Lasik surgery occur
Lasik’s risks. Once you understand in approximately 4% of eyes operated
these risks, you may conclude that the on.4 These complications often produce
prudent course of action is to avoid the vision-distorting irregular astigmatism.
Lasik fad until the procedure has fully Unlike regular astigmatism, which is
matured, withstood the test of time, and correctable with glasses, irregular
been proven safe. After all, we’re 1
See Premarket Approval Application
talking about your eyes. #P970043/S5, available through Dockets
Management Branch (HFA-305), FDA, p.19.
1. The True Degree of Risk is Unclear
2
Approved May 9, 2000. See Docket #OOM-
1592, p.1.
and is Being Downplayed. 3
See Premarket Approval Application, p. 23.
4
See Sugar A. et. al., LASIK for Myopia and
Astigmatism: Safety and Efficacy, OPHTH.,
Vol. 109, pp.175-87, 2002.
UPDATED 9/30/09
astigmatism cannot be corrected with that of Visx’s broad beam laser, yet both
glasses. Rigid Gas Permeable (RGP) are touted as being “state of the art.”
contact lenses offer some hope to those Many surgeons cut the Lasik flap
suffering from Lasik-Induced Irregular from side to side (a nasal hinge) because
Astigmatism (LIIA) because they they feel that this method transcects
provide a smooth surface that masks fewer nerves.5 Other surgeons prefer the
corneal irregularities by permitting “up-down” flap.
pooling of tears beneath the lens. The field of refractive surgery is still
However, due to the flattening of the so young that many ophthalmologists
cornea following Lasik, it is nearly develop and market their own surgical
impossible to find RGP lenses that will instruments to perform various
stay centered over the pupil and will not procedures, such as cutting, lifting, or
rub against the interface between treated irrigating flaps. Perhaps some of their
and untreated areas of the cornea. The enthusiasm for Lasik stems from the
result is that RGP lenses are extremely goal of “creating rapid profits by
uncomfortable for the post-refractive promulgating sales of surgical
and therefore do not offer a viable equipment and adopting new surgical
solution to irregular astigmatism. New techniques,” as one eminent refractive
laser techniques involving eye tracking surgeon has speculated.6
can treat irregular astigmatism, but they Marketers recognize a type of
are yielding mixed results and may consumer known as the “early adopter,”
never be precise enough to correct LIIA. someone who enjoys buying products
Many ophthalmologists are unaware with the latest technology. Refractive
of Lasik’s true risks because they tend to surgeons are also keenly aware of this,
avoid patients with post-Lasik and most medical texts about Lasik
complications, given that it is less contain one or more chapters on how to
profitable to treat such a patient than to boost profits by targeting such
operate on a fresh candidate. These consumers. The discussion of marketing
doctors therefore never gain an accurate strategies in medical texts speaks
awareness of the extent of damage that is volumes about the commercialized
being done by Lasik. nature of this field of “medicine.”
Perhaps you are wondering why this Recent studies have indicated that people
side effect of Lasik has gone largely who undergo Lasik are at greater risk of
unnoticed in the United States. The developing Iatrogenic Keratectasia
reason is that, although contrast (Ectasia) due to corneal thinning.23
sensitivity tests are easy to administer Ectasia, one of the most devastating
both pre- and post-operatively, they complications of Lasik, is the weakening
consume more time than most of the cornea to such an extent that the
ophthalmologists are willing to spend eye’s natural intra-ocular pressure causes
with their patients. If refractive the cornea to bulge forward, resulting in
surgeons took the time to perform all the distorted vision, return of myopia,
recommended diagnostic tests, they irregular astigmatism, and fluctuating
would be spending several hours with vision. In the worst cases of ectasia, the
each patient and the procedure would only remedy is a full-scale corneal
quickly become uneconomical for them. transplant. Even patients with low
Therefore, they generally only spend degrees of myopia can suffer from
about one or two hours giving their Lasik-Induced Ectasia (LIE).24
patients a stripped-down pre-operative The long-term weakening of the
evaluation. Issues such as the effect of cornea has been well documented in
Lasik on contrast sensitivity get lost in other cases of corneal refractive surgery,
the rush to put more patients through the including radial keratotomy. Although
Lasik mill.20 the mechanism of weakening is different
in incisional surgery, it may be even
5. Lasik Reduces the Cornea’s more profound in excisional surgery
Structural Stability. such as Lasik.25 Furthermore, the flap
that is created in Lasik will never again
The cornea has a natural tendency to adhere to the underlying corneal bed,26
become thinner with age.21 Combine 23
See B. Seitz et. al., Posterior Corneal
this with the surgical removal of corneal Curvature Changes After Myopic Lasik, OPHTH.,
tissue through Lasik, and there can Vol. 108(4), Apr. 2001, pp. 666-72; T. Baek et.
potentially be serious problems.22 al., Factors Affecting the Forward Shift of
Posterior Corneal Surface After Lasik, OPHTH.,
19
See id. See also, Maxine Lipner, Inside Lasik Vol. 108(2), Feb. 2001, pp. 317-20.
– First on the Endothelial Cell Block, 24
See S. Percy Amoils, Mark Deist, Petrus
EYEWORLD , Sep. 2000. (noting recent studies Gous, Philippa Amoils, Iatrogenic Keratectasia
indicating endothelial cell damage resulting after Laser In-Situ Keratomileusis for Less Than
from excimer laser radiation). -4.0 to -7.0 Diopters of Myopia, J. CATARACT
20
This rush to operate is exemplified by a recent REFRACT. SURG. 2000, Vol. 26(7), Jul. 2000,
advertisement by the Hillside PlusCare pp. 967-77.
Network, directed at refractive surgeons eager 25
See Richard E. Damiano, M.D., Late Onset
to acquire more Lasik patients. It exclaimed, Regression After Myopic Keratomileusis –
“What do You Feed a Hungry Laser? Patients!” Letter to the Editor, J. REFRACT. SURG., Vol. 15,
21
See AM. ACAD. OPHTH., External Disease and Mar./Apr. 1999. See also Theo Seiler, M.D.,
Cornea – Basic and Clinical Science Course, Iatrogenic Keratectasia: Academic Anxiety or
1998-9, p. 338. See also ARCH. OPHTH., Serious Risk?, J. CATARACT REFRACT. SURG., Vol.
Changes With Age in Normal Cornea, (1982) 25(10), Oct. 1999.
Vol. 100, p. 1942. 26
See George O. Waring, M.D., Enhancements
22
See George O. Waring III, The Limits of Are a Reality of Refractive Surgery, OPHTH.
Keratomileusis, Special Article, ARCH. OPHTH., TIMES , Oct. 2001 (noting that a Lasik flap can be
Vol. 117(8), Aug. 1999 (noting that there is no lifted indefinitely by breaking the peripheral
published long-term follow-up on a consecutive wound with an IOL hook); Experts Search
series of eyes with a thorough statistical analysis Refractive Surgery’s Outer Limits, EYEWORLD,
of changes in corneal curvature after Lasik). Apr. 2003 (quoting Dr. Edward E. Manche,
UPDATED 9/30/09
further reducing the cornea’s tensile Myopia reduces and can even
strength. eliminate the need for reading glasses,
The process by which the cornea is which compensate for the greater
weakened following Lasik is poorly rigidity of the eyes’ lenses as we age.
understood because no statistically valid This rigidity reduces the lens’ ability to
scientific studies have been performed. accommodate in order to focus on near
According to one renowned refractive objects. Thus myopia eventually
surgeon, “We have failed to ask some becomes your friend. In cases of mild
fundamental questions about the stability myopia, to read you simply remove your
of refraction of the human eye.”27 Dr. glasses. In cases of more severe myopia,
Richard J. Maw, Medical Director for the image minification effect of glasses
LasikPlus in Las Vegas, Nevada, has makes it more comfortable for the eye to
noted that “Sadly, avoiding ectasia is see close-up objects. Thus people with
currently as much an art as it is a science high degrees of myopia may never even
for refractive surgeons; there is no need bifocals due to the image
standard protocol for them to minification produced by their glasses.
follow….even the most experienced Refractive surgery to eliminate
ophthalmologist is challenged to identify myopia thus improves distance vision at
corneas that…may become ectatic after the expense of near vision. Eliminate
Lasik.”28 the need for glasses by having Lasik at
the age of, say, 30, and within little more
6. Lasik Can Cause Photophobia. than a decade you will start having to
deal with the inconvenience of carrying
Photophobia is the painful sensitivity reading glasses with you at all times in
to light that often results from Lasik. order to do any close-up work such as
Though the exact causes of post-Lasik read, use the computer, or even see your
photophobia are unknown, some wristwatch.
surgeons hypothesize that light scatter
and glare resulting from post-Lasik 8. Lasik Indirectly Increases the Risk
corneal surface irregularities are the of Cataracts.
culprits.
Steroid medications such as
Tobradex, Alrex, Pred Forte, and FML,
7. Myopia Will Eventually Be Your the standard treatments for several post-
Friend. Lasik complications, have been proven
to induce posterior subcapsular cataracts
if taken for prolonged periods.29 Though
“I’ve lifted flaps six, eight, or even 10 years prolonged use of steroids is usually not
after Lasik, and there’s absolutely no trouble at necessary following Lasik, there are
all.”).
27
See Chris Glenn, REV. OPHTH., Apr. 2000 29
See PDR OPHTH., 1999, p. 244;
(quoting Dr. Daniel Z. Reinstein, MD, MA, Flurometholone-Induced Cataract After PRK,
FRCSC, Professor of Ophthalmology at the OPHTHALMOLOGICA 1997, pp. 394-6 (noting the
University of Paris, Associate Professor at case of a 24-year-old woman who developed
Cornell University, and former National cataracts after using FML 4-7 times per day for
Medical Director for Lasik Vision Corp. of 4 months); and Lens & Cataract, § 11, BASIC &
Vancouver, B.C.). CLINICAL SCIENCE COURSE, AM. ACAD. OPHTH.
28
Richard J. Maw, M.D., Avoiding (noting that 50% of patients developed cataracts
Postoperative LASIK Ectasia, CATARACT after receiving 765 drops of topical steroid over
REFRACT. SURG. TODAY, Nov/Dec 2003, p.69. 10.5 months).
UPDATED 9/30/09
several complications (e.g., corneal for surgery stretches the eyelids so much
abrasion, infection, haze) that require that the upper lid’s levator complex can
extended treatment using steroid drops. be damaged.32 This potentially
permanent condition, known as
9. Lasik Causes Drier Eyes. logophthalmos, can reduce the blink rate
or cause eyelids to open partially during
Post-Lasik Dry Eye (PLDE) is quite sleep, causing more tear evaporation.
common, and its treatment is one of the Second, placement of the suction
most difficult problems facing refractive ring at the limbus in order to stabilize
surgeons.30 For the patient, it is an the eye prior to creating the flap disrupts
uncomfortable and often painful the production of goblet cells.33 Goblet
condition that persists indefinitely. cells are necessary in order to maintain a
According to Dr. Paul M. Karpecki, OD, stable tear film.34
Clinical Director of Cornea and Third, the process of cutting the
Refractive Surgery for Hunkeler Eye Lasik flap damages many of the nerves
Centers, “Not all patients are affected, that signal the lacrimal glands to
but a very high percentage are.”31 produce tears.35 By one estimate, nearly
The reason PLDE is so difficult to 70% of corneal nerves are severed
treat is that the Lasik procedure disrupts during flap creation.36 Severing these
so many facets of the eye’s tear nerves renders the ocular surface
production mechanism. hypesthetic,37 a problem also known as
First, insertion of a speculum in Lasik-Induced Neurotrophic
order to expose the eye in preparation Epitheliopathy (LINE) or “de-
38
enervation.”
30
See Eric Donnenfeld, MD, At Issue: Tears
Versus Plugs in Post-Lasik Patients, OCULAR
SURG. NEWS, Jun. 1, 2000. See also Eye Drops 32
See David S. Gartry et. al., Prevention and
Help in Management of Dry Eye Symptoms, Management of Complications of
OPHTH. TIMES, Jun. 1, 1999 (“Dry eye is a Photorefractive Keratectomy, in Olivia N.
common occurrence following LASIK surgery. Serdarevic, REFRACT. SURG.: CURRENT TECHNIQUES
Creation of the flap denervates the cornea & MANAGEMENT (1997), p. 91.
overlying the flap, and decreased corneal 33
See Diane M. Watson, Patient Education,
sensation decreases tear production, thereby Proactive Approach Crucial When Treating
increasing osmolarity.”). See also Testimony of Lasik-Induced Dry Eye, PRIM. CARE OPTOM.
Dr. Howard Fine before the FDA’s Ophthalmic NEWS, May 2000.
Devices Panel, Nov. 30, 2001 (“As we all 34
See R.B. Grene, Setting New Standards for
know, Lasik transects the corneal nerves, Lasik Flaps, OPHTH. MAN., Apr. 2001.
therefore inducing dry eyes in most patients.”); 35
See Eric Donnenfeld et. al., The Effect of
EYEWORLD, Guest Ed., 6/02 (“One thing we have Hinge Position on Corneal Sensation Following
been finding is that corneal sensation is LASIK, paper presented at SYMP. CATARACT, IOL,
markedly decreased even a year and a half after & REFRACT. SURG., Apr./May 2001 (noting that
LASIK in some patients. It is probably worse the long posterior corneal nerves enter the eye
than we thought and that is probably why a lot at 3 and 9 o’clock. A superior hinged flap
of people are seemingly getting dry eye.”). transects both arms of the neural plexus, while a
31
See Eric Donnenfeld, MD, At Issue: Tears nasal hinge transects only the temporal arm.).
Versus Plugs in Post-Lasik Patients, OCULAR See also Richard L. Lindstrom, M.D., At Issue:
SURG. NEWS, Jun. 1, 2000; REV. OPT, Feb. 15, Tears Versus Plugs in Post-Lasik Patients,
2001 (listing Lasik as a major cause of dry eye); OCULAR SURG. NEWS, Jun. 1, 2000.
Hovanesian, Shah, and Maloney, Symptoms of 36
See R.B. Grene, Setting New Standards for
Dry Eye and Recurrent Erosioin Syndrome Lasik Flaps, OPHTH. MAN., Apr. 2001.
After Refractive Surgery, J. CATARACT REFRACT. 37
See Richard L. Lindstrom, M.D., At Issue:
SURG., Apr. 2001, 577-84 (noting dryness Tears Versus Plugs in Post-Lasik Patients,
symptoms in 48% of post-Lasik patients). OCULAR SURG. NEWS, Jun. 1, 2000.
UPDATED 9/30/09
Fourth, ablating the cornea with the and may even need to have punctum
laser further destroys corneal nerves. plugs inserted into their eyes’ drainage
The depth of the corneal ablation affects ducts in order to reduce the outflow of
the extent of LINE. According to one the few precious tears they have left. In
study, corneal sensitivity does not some cases, punctum plugs can cause
recover to the preoperative level even eye infections, and the only long-term
six months after Lasik.39 solution to dry eyes becomes permanent
Fifth, the laser alters corneal cauterization of the tear ducts.
curvature. In a normal, pre-surgical eye, It should be noted that PLDE,
the congruity of the lid and globe although uncomfortable in and of itself,
provides a uniform tear distribution also reduces visual acuity. The eye’s
during blinking so that the forces of tear film reduces micro-irregularities
shear, which could disturb the tear film, that naturally occur on the epithelial
are kept to a minimum. Lasik reduces surface. If this tear film is disrupted, the
this congruity, thus making it difficult to result is that these normal micro-
produce and maintain a continuous tear irregularities are no longer masked by
film.40 the smooth surface previously created by
Sixth, Lasik causes a temporary the tear film.43 As one doctor has noted,
post-surgical gap between the corneal “In some cases, dry eye symptoms may
flap and the bed, impeding the transfer eliminate the advantages of the positive
of cells between the two and thus visual results of the procedure.”44
preventing the full recovery of damaged
nerves.41 10. Lasik’s Long-Term Risks are
The Lasik patient will typically Unknown.
experience PLDE for at least two
months after surgery. Eye drops must Refractive surgeons acknowledge
constantly be applied, and the individual that the long-term risks of Lasik are
will often wake up in the middle of the poorly understood, one reason why most
night with severely dry, scratchy eyes will not have their own eyes surgically
that need to be lubricated again. altered.45 Peruse ophthalmological
However, PLDE sufferers may have to literature and you will quickly see how
use expensive eye drops indefinitely, 42 much is being learned about the long-
38
See Rosan Y. Choi, M.D. and Steven E. term optical and physiological
Wilson, M.D., LASIK-Induced Dry Eye Can Be
Managed, OCULAR SURG. NEWS, Jan. 1, 2001.
39
See Wan-Soo Kim, MD, PhD, Jeong-Sam excimer lasers used to perform Lasik.
Kim, MD, Change in Corneal Sensitivity 43
See J. Charles Casebeer, Luis Ruiz, &
Following Lasik, J. CATARACT REFRACT. SURG., Stephen Slade, LAMELLAR REFRACT. SURG., 1996,
Vol. 25, Mar. 1999. p.29.
40
See R.B. Grene, Setting New Standards for 44
See At Issue: Post-LASIK Dry Eye, OC. SURG.
Lasik Flaps, OPHTH. MAN., Apr. 2001. NEWS, Europe/Asia-Pacific Ed., Apr. 2002.
41
See Wan-Soo Kim, MD, PhD, Jeong-Sam 45
See Kerry Solomon, M.D., Refractive Surgery
Kim, MD, Change in Corneal Sensitivity Survey 2001 Results, available at
Following Lasik, J. CATARACT REFRACT. SURG., http://www.aao.org/aaoweb1/Newsroom/1152_1
Vol. 25, Mar. 1999. 28.cfm#rs. See also Amy Oravec, LASEK’s
42
The recent proliferation of artificial tear Impact on the Microkeratome, CATAR. &
brands such as Theratears, Genteal, and Refresh REFRACT. SURG. TODAY, 6/2/03 (quoting Louis
is more than coincidental with the increase in Probst saying “…sometimes new procedures are
refractive surgical procedures. It is interesting embraced enthusiastically by the refractive
to note that the manufacturers of many of these community before we have all the relevant
artificial tear drops also manufacture the information.”).
UPDATED 9/30/09
Post-Lasik Starbursts.
UPDATED 9/30/09
Post-Lasik Ghosting of Eyechart. Refractive Dry Eye Syndrome - Goblet cell disruption
Surgeons Consider This to be 20/20 Vision. and corneal nerve damage decrease tear
production, leading to dry eye discomfort
and necessitating constant use of eye drops
and/or punctum plugs and/or cauterization
to occlude the drainage ducts.