The Great Femtosecond Face-Off: Carl Zeiss Meditec VisuMax

The Great Femtosecond Face-off:
Carl Zeiss Meditec VisuMax
Dan Z Reinstein MD MA(Cantab) FRCSC FRCOphth1,2,3,4
1. London Vision Clinic, London, UK

2. St. Thomas’ Hospital - Kings College, London, UK
3. Weill Medical College of Cornell University, New York,
4. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche) , Paris, France
Financial Disclosure
The author (DZ Reinstein) acknowledges a

financial interest in Artemis™ VHF digital
ultrasound (ArcScan Inc, Morrison, CO)
The author (DZ Reinstein) is a consultant for

Carl Zeiss Meditec AG (Jena, Germany)
©DZ Reinstein 2009

dzr@londonvisionclinic.com
VisuMax Femtosecond System
• The Bermuda triangle of treatment parameters
– Short procedure time
– Easy flap lift / tissue separation
– Excellent cut quality
– No adverse effects (DLK, TLS)
– Accurate focusing
• Flaps
• FLEX
Precise
Spot Energy
Focusing
0.1 µJ ~1 µm
500 kHz Pulse

Rate
©DZ Reinstein 2009

VisuMax Femtosecond System
• Zeiss high performance optics key for optimum cut
▼ low Numerical aperture high ▲

▼ large Spot diameter small ▲
▼ low Depth accuracy high ▲
▼ high Single pulse energy small ▲
©DZ Reinstein 2009

1. High Flap Thickness Reproducibility
2. Low Corneal Suction
3. Centration on the Corneal Vertex
4. Ultra Thin Flap
5. Flaps "Made to Measure"
6. Flaps in “Difficult” Eyes
7. Visual Outcomes
8. Future Potential: All-in-One
4. Ultra Thin Flap
7. Visual Outcomes
Assessment of VisuMax Flap Thickness
• 24 eyes treated with intended flap thickness of 110 µm
• Central flap thickness measured by Artemis
J Refract Surg. Online Pre Release.
©DZ Reinstein 2009

Artemis very high-frequency digital ultrasound arc-scanner
ArcScan Inc
Evergreen, Colorado
Surface localization:
• Digital signal processing significantly reduces noise
0.87 µm and enhances signal-to-noise ratio compared to
analog signal processing
• doubles resolution
• increase measurement precision by a factor of 3
• Thickness measurements made by computer-
analysis of peaks on the I-scan trace – each peak
provides a surface localization of 0.87 µm
• 3D layered pachymetry precision
• Epithelium – 0.61 µm
• Cornea – 0.74 µm
• Flap – 1.14 µm
©DZ Reinstein 2009

Flap Thickness Measurement
• 3D VHF digital ultrasound flap thickness measurement
before and 3 months after treatment with Artemis I
• Central flap thickness =
Thickness of the stromal component of the flap
measured 3 months after surgery
+ Preoperative epithelial thickness
Epithelial
thickness
Pre-op
+
Stromal Flap
thickness
Post-op
3 months
©DZ Reinstein 2009
Artemis B-Scan: 6 Months Post LASIK
Artemis B-Scan (above) of VisuMax Flap 6 months post LASIK.

Edge detection by I-scan digital signal processing (red outline,
below) based on raw scan data
©DZ Reinstein 2009

RESULTS: Central Flap Thickness
Intended flap thickness = 110.00 µm

Average flap thickness = 112.31 µm
Accuracy = +2.31 µm
Precision (SD) = 7.89 µm
Minimum flap thickness = 102.61 µm
Maximum flap thickness = 132.94 µm
Range = 30.34 µm
©DZ Reinstein 2009

RESULTS: Central Flap Thickness
• 25% of eyes within 2 µm of the intended flap thickness

• 54.2% of eyes within 5 µm of the intended flap thickness
• 87.5% of eyes within 10 µm of the intended flap thickness
©DZ Reinstein 2009

Flap Thickness Reproducibility: Published
Author Microkeratome Accuracy (µm) SD (µm) Pachymetry Method Pachymetry Instrument
Stahl 2007 IntraLase FS60 +12.0 5.0 1 Mo Post-op OCT Visante
Pietila 2009 Femto LDV -20.0 5.0 Intra-op US SP-3000
Alio 2008 IntraLase FS30 +6.0 6.2 1 Mo Post-op VHFU Artemis-2
Hu 2007 IntraLase FS30 +13.9 7.1 3 Mo Post-op CMTF NR
Reinstein 2009 VisuMax +2.3 7.9 Pre and 3 Mo Post-op VHFU Artemis-1
Li 2007 IntraLase (Pulsion) +35.0 9.0 1 Wk Post-op OCT CAS-OCT
Holzer 2006 Femtec -0.4 9.1 Micrometer Digimatic
Sutton 2008 IntraLase FS30 -1.0 9.8 Intra-op US Corneo-Gage Plus
Binder 2006 IntraLase FS10 +35.8 10.1 Intra-op US Cornea Scan II 50 MHz
Holzer 2006 Femtec +3.7 10.7 Micrometer Digimatic
Sutton 2008 IntraLase FS15 +11.8 10.8 Intra-op US Corneo-Gage Plus
Li 2007 IntraLase (Pulsion) +30.0 11.0 Intra-op US Corneo-Gage 2 50 MHz
Li 2007 IntraLase (Pulsion) +36.0 11.0 1 Wk Post-op OCT CAS-OCT (Visante prototype)
Holzer 2006
Hu 2007
Femtec
IntraLase FS15
Two studies done with Artemis
-7.9
+16.8
11.1
11.1
Micrometer
3 Mo Post-op CMTF
Digimatic
NR
Binder 2004 IntraLase FS +2.4 11.9 Intra-op US NR
Binder 2004 IntraLase FS +15.0 12.0 Intra-op US NR
Talamo 2006 IntraLase FS +9.0 12.0 Intra-op US Pachette II
Kim 2008 IntraLase FS60 +8.9 13.6 3 Mo Post-op OCT Visante
Pfaeffl 2008 IntraLase FS30 +0.4 13.6 Intra-op OCP Online OCP
Kezirian 2004 IntraLase FS -16.0 14.0 Intra-op US Pachette 50/60 KHz pachymeter
Neuhann 2008 IntraLase FS30 +11.7 14.7 Intra-op OCP Online OCP
Binder 2004 IntraLase FS -1.3 16.6 Intra-op US NR
Binder 2006 IntraLase FS10 -0.4 17.1 Intra-op US Cornea Scan II 50 MHz
Kim 2008 IntraLase FS60 +4.8 17.6 3 Mo Post-op OCT Visante
Binder 2004 IntraLase FS -7.5 18.5 Intra-op US NR
Binder 2006 IntraLase FS10 -9.4 19.0 Intra-op US Cornea Scan II 50 MHz
Li 2007 IntraLase (Pulsion) +40.0 19.0 Intra-op US Corneo-Gage 2 50 MHz
©DZ Reinstein 2009

Validity of Measurement Instrument
Measurement Precision
Data Reproducibility
©DZ Reinstein 2009

95% values within 2 standard deviations
90 95 100 105 110 115 120 125 130
Measured Flap Thickness
©DZ Reinstein 2009

Precision: 1 µm
95% within: 108-112 µm
90 95 100 105 110 115 120 125 130
©DZ Reinstein 2009

Precision: 10 µm
95% within: 90-130 µm
90 95 100 105 110 115 120 125 130
©DZ Reinstein 2009

95 104 105 106 114 115 116 125
Value 1 Value 2
Instrument 1
Valid
Instrument 2
Invalid
©DZ Reinstein 2009

Reproducibility: 5 µm
Required Precision: 2.5 µm
©DZ Reinstein 2009
Reproducibility: 5 µm
Ideal Precision: 1.66 µm
©DZ Reinstein 2009
Artemis Flap Thickness

Repeatability: 1.14 µm
Therefore, the Artemis is capable of measuring a flap

thickness reproducibility of 7.89 µm as found in this study
©DZ Reinstein 2009

Artemis Flap Thickness

Repeatability: 1.14 µm
The Artemis is capable of measuring a flap thickness

reproducibility as small as 3.42 µm
©DZ Reinstein 2009

4. Ultra Thin Flap
7. Visual Outcomes
VisuMax Femtosecond System: Patient Comfort
Cross section of the contact glass

• Spherical contact interface to cornea
• Low corneal suction
– Minimal applanation
– Minimal IOP increase
– No vision loss during suction (data on file)
• “Out-to-in” femtosecond ablation
– Fixation throughout flap creation
©DZ Reinstein 2009

IOP Comparison: VisuMax vs IntraLase
Comparison of typical curves plotted on the same scale
350 IntraLase
300 VisuMax
250
IOP (mmHg)
200
150
100
50
0
0 20 40 60 80 100
time (sec)
Ref: Grabner G. Femtosecond to fully replace microkeratome.
Ophthalmology Times, 2008
©DZ Reinstein 2009
IOP Comparison: VisuMax vs IntraLase
Comparison of typical curves plotted on the same scale
350 IntraLase
300 VisuMax Fast
250
VisuMax flap creation time
IOP (mmHg)
200 reduced to ~20 seconds

with software v 2.4.0
150
100
50
0
0 20 40 60 80 100
time (sec)
Ref: Grabner G. Femtosecond to fully replace microkeratome.
Ophthalmology Times, 2008
©DZ Reinstein 2009
Questionnaire: Patient Experience
VisuMax vs Hansatome
Questionnaire: Claustrophobia
Did you feel a sense of claustrophobia when the

machine was maneuvered onto your eye?
70.0%
58.3%
60.0%
Percentage Patients
50.0% 46.2%
40.0%
30.8%
30.0% 25.0%
20.0% 15.4% 16.7%
10.0% 7.7%
0.0%
0.0%
none at all not really a little a lot
VisuMax [12] 58.3% 25.0% 16.7% 0.0%
Hansatome [13] 15.4% 46.2% 30.8% 7.7%
©DZ Reinstein 2009

Questionnaire: Discomfort from Pressure
What level of discomfort did you experience while

the pressure was applied to the eye and the laser
was used to create the flap (green light became
obscured)?
50.0% 46.2%
41.7%
Percentage Patients
40.0%
33.3%
30.8%
30.0%
20.0% 16.7%
7.7% 8.3% 7.7%

10.0%
0.0% 0.0%
0.0%
very very
comfortable uncomfortable painful
comfortable uncomfortable
VisuMax [12] 16.7% 41.7% 33.3% 8.3% 0.0%

Hansatome [13] 7.7% 30.8% 46.2% 7.7% 0.0%
©DZ Reinstein 2009

Questionnaire: Length of Time With Pressure
How did you feel about the length of time that

pressure was applied on the eye?
90.0%
80.0% 76.9%
Percentage Patients
70.0%
60.0%
50.0%
50.0%
41.7%
40.0%
30.0%
20.0% 15.4%
8.3% 7.7%
10.0%
0.0% 0.0%
0.0%
quick not too long too long far too long
VisuMax [12] 50.0% 41.7% 8.3% 0.0%
Hansatome [13] 15.4% 76.9% 7.7% 0.0%
©DZ Reinstein 2009

4. Ultra Thin Flap
7. Visual Outcomes
VisuMax Femtosecond System: Centration
• Internal fixation target for patient – refraction corrected
• Patient compliance
• Auto centration on docking to contact glass – corneal vertex
• Patient visualisation of the target throughout the procedure
©DZ Reinstein 2009

Flap Centration on Corneal Vertex
©DZ Reinstein 2009

Flap Centration on Corneal Vertex
Corneal vertex
Dye pooling in
ablation zone Flap edge
©DZ Reinstein 2009

4. Ultra Thin Flap
7. Visual Outcomes
Ultra Thin Flap LASIK: No Need For PRK
• PRK Corneal Thickness Limit: 350 µm
• Alternative: Ultra Thin Flap LASIK

– VisuMax Flap Thickness: 80 µm
– Corneal Thickness: 350 µm
– LASIK RST = 350 – 80 = 270 µm (>250 µm)
Flap thickness: 84 µm
©DZ Reinstein 2009

4. Ultra Thin Flap
7. Visual Outcomes
Flap Creation with Previous PRK
Epithelium Post PRK for +3.00 D
Thick epithelium after

hyperopic PRK
Flap underneath epithelium
©DZ Reinstein 2009

Recutting Flaps: Measure Twice, Cut Once!
Incomplete Flap: Hansatome

zero compression microkeratome
©DZ Reinstein 2009

Second flap created under the half flap

using the VisuMax femtosecond laser
©DZ Reinstein 2009

• Original flap created in 1999
• Measure Once: Artemis scan to measure flap thickness
Flap Thickness
Profile
©DZ Reinstein 2009

• Micro-bubble layer created with the VisuMax
• Measure Twice: Artemis scan repeated before lifting the flap
• Confirmed that the VisuMax flap was below original flap
VisuMax Micro-Bubble Layer Creation
©DZ Reinstein 2009

• Flap lifted and ablation performed
• Artemis scan 1 month post-op confirmed VisuMax flap below
original flap
©DZ Reinstein 2009

4. Ultra Thin Flap
7. Visual Outcomes
VisuMax when Hansatome not Possible
Hansatome VisuMax
Forced to Retreatment
switch to PRK as VisuMax
©DZ Reinstein 2009
VisuMax Flap in RK Patient
©DZ Reinstein 2009

VisuMax Flap in Deep Lamellar Keratoplasty
©DZ Reinstein 2009

4. Ultra Thin Flap
7. Visual Outcomes
VisuMax Population
• 232 eyes of 131 patients
• Age
– median 38 years
– range 21 to 68 years
• Spherical equivalent
– mean -4.00 ± 1.86 D
– range -0.13 to -8.63 D
• Cylinder
– mean -0.72 ± 0.54 D
– range 0.00 to -2.50 D
• BSCVA
– 100% 20/20
– 59% 20/16
©DZ Reinstein 2009
Attempted vs Achieved: 6 Months
Attempted vs. Achieved Spherical Equivalent
-9
Achieved Spherical Equivalent (Diopters)
-8
y = 0.9201x - 0.1442
-7 R2 = 0.952
-6
-5
-4
-3
-2
-1
0
0 -1 -2 -3 -4 -5 -6 -7 -8 -9
Attempted Spherical Equivalent (Diopters)

©DZ Reinstein 2009
Accuracy 6 Months: Within Range of Intended
Accuracy: Within Range of Intended
45%
41%
40%
35%
Percentage Eyes
30%
26%
25%
20%
15%
15% 13%
10%
4%
5% 1% 1%
0% 0%
0%
-2.00 -1.50 -1.00 -0.50 -0.13 0.14 +0.51 +1.01 +1.51
To - To - To - To - To To To To To
1.51 1.01 0.51 0.14 0.13 +0.50 +1.00 +1.50 +2.00
VisuMax [232] 0% 1% 15% 41% 26% 13% 4% 1% 0%
Accuracy of Spherical Equivalent
©DZ Reinstein 2009

Efficacy 6 Months: Binocular Vision
Efficacy: Binocular UCVA

98% 100% 100% 100%
100% 96%
80% 75%
Percentage Eyes
60%
40% 36%
20%
0%
20/12.5 20/16 20/20 20/25 20/32 20/40 20/63
Efficacy 36% 75% 96% 98% 100% 100% 100%
Binocular UCVA
©DZ Reinstein 2009

Efficacy 6 Months: Monocular Vision
Efficacy: Monocular UCVA

100% 100%99% 99% 100% 100%
100% 96%
80%
Percentage Eyes
62%
59%
60%
40%
20% 16%
9%
0%
20/12.5 20/16 20/20 20/25 20/32 20/40 20/63
Pre BSCVA 9% 59% 100% 100%
Efficacy 16% 62% 96% 99% 99% 100% 100%
Monocular UCVA
©DZ Reinstein 2009

Safety 6 Months: Lines Change BSCVA
Safety: Lines Change BSCVA
60% 55%
Percentage Eyes
40%
40%
20%
3% 2%
0.0% 0.0%
0%
Loss 3 or Gain 2 or
Loss 2 Loss 1 No Change Gain 1
More More
Safety 0.0% 0.0% 3% 55% 40% 2%
Lines Change BSCVA
©DZ Reinstein 2009

Stability: Change in Spherical Equivalent
Stability: Change in Spherical Equivalent
2.00
Spherical Equivalent (D)
1.00
0.00
-1.00
-2.00
-3.00
-4.00
-5.00
-6.00
-7.00
Pre op 1 day 1 month 3 months 6 months
Time Point
Pre Op 1 Day 1 Month 3 Months 6 Months

Avg SEQ -4.06 +0.37 -0.08 -0.15 -0.17
SD SEQ 1.85 0.36 0.43 0.42 0.41
# eyes 232 228 223 203 222
©DZ Reinstein 2009

4. Ultra Thin Flap
7. Visual Outcomes
VisuMax Unsurpassed Future Potential
• The new horizon of femtosecond technology in
ophthalmology
• VisuMax is designed to become the corneal surgery
workstation for a large spectrum of procedure options
• Unprecedented accuracy in corneal incisions
– eg Femtosecond lenticule extraction (FLEx)
©DZ Reinstein 2009

Dan Z Reinstein MD MA(Cantab) FRCSC

FRCOphth1,2,3,4
1. London Vision Clinic, London, UK

2. St. Thomas’ Hospital - Kings College, London, UK
3. Weill Medical College of Cornell University, New York,
4. Centre Hospitalier National d’Ophtalmologie, (Pr. Laroche) , Paris, France
Thank You
Comparison with IntraLase
IntraLase Claims vs VisuMax
• Lack of clinical data

• Few “champion” users
• Instability
• Curved glass can't work properly
• IOP
• Flap diameter
• No recentration software
• Can't do oval flap
• Can't do ICRS
• Faster?
©DZ Reinstein 2009
• Lack of clinical data • Reinstein et al

– Accuracy and Reproducibility of Central
• Few “champion” users Flap Thickness and Visual Outcomes of
LASIK with the VisuMax Femtosecond
• Instability Laser System and the MEL80 Excimer
Laser
• Curved glass can't work properly – JRS [Online]
• IOP • Blum et al
• Flap diameter – LASIK for Myopia Using the Zeiss
VisuMax Femtosecond Laser and MEL
• No recentration software 80 Excimer Laser
– JRS [Online]
• Can't do oval flap • Sekundo et al
• Can't do ICRS – First efficacy and safety study of
femtosecond lenticule extraction for the
• Faster? correction of myopia Six-month results
– JRS Sept 2008
©DZ Reinstein 2009

• Few “champion” users • Dan Reinstein
• Instability • So what? It’s just newer!
• IOP
• Flap diameter
• Can't do ICRS
• Faster?
©DZ Reinstein 2009

• Instability • Instability and crashes have
• Curved glass can't work properly been ironed out since the
• IOP prototype
• Flap diameter
• Can't do ICRS
• Faster?
©DZ Reinstein 2009

• Instability
• Curved glass can't work properly • Curved glass is auto-
• IOP calibrated for each lens
• Flap diameter
• Can't do ICRS
• Faster?
©DZ Reinstein 2009
• Lack of clinical data • IOP has been shown to be

• Few “champion” users lower for VisuMax than
IntraLase (Grabner)
• Instability – VisuMax: 84 mmHg
• Curved glass can't work properly – IntraLase: 180 mmHg
• IOP • IOP raised for shorter
• Flap diameter duration
• No recentration software – VisuMax: ~30 seconds
• Can't do oval flap – IntraLase: ~80 seconds
• Can't do ICRS • Patient can see during
• Faster? procedure
©DZ Reinstein 2009


• Instability
• IOP
• Flap diameter
• • Reinstein data showed
No recentration software
achieved flap diameter 0.50
• Can't do oval flap mm greater than displayed
• Can't do ICRS • Recentration with IntraLase
• Faster? reduces flap diameter
©DZ Reinstein 2009

• Instability
• IOP
• Flap diameter
• Can't do oval flap • Not required as VisuMax
• auto-centrates on the
Can't do ICRS corneal vertex
• Faster?
©DZ Reinstein 2009

• Instability
• IOP
• Flap diameter
• Can't do ICRS • Why do you need an oval flap?
• Faster? • Induce astigmatism?
©DZ Reinstein 2009

• Instability
• IOP
• Flap diameter
• Can't do ICRS
• Faster? • ICRS settings in the pipeline
along with graft, AK etc
©DZ Reinstein 2009

• Instability
• IOP
• Flap diameter
• • Total time for IntraLase is
No recentration software
longer
• Can't do oval flap – Ring segment placement
• Can't do ICRS – Docking of lens
• Faster? – Ablation
©DZ Reinstein 2009

The Great Femtosecond Face-Off: Carl Zeiss Meditec VisuMax

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The Great Femtosecond Face-off:

Carl Zeiss Meditec VisuMax

Dan Z Reinstein MD MA(Cantab) FRCSC FRCOphth1,2,3,4

1. London Vision Clinic, London, UK

The author (DZ Reinstein) acknowledges a

The author (DZ Reinstein) is a consultant for

©DZ Reinstein 2009

500 kHz Pulse

©DZ Reinstein 2009

▼ low Numerical aperture high ▲

©DZ Reinstein 2009

J Refract Surg. Online Pre Release.

©DZ Reinstein 2009

©DZ Reinstein 2009

Artemis B-Scan (above) of VisuMax Flap 6 months post LASIK.

©DZ Reinstein 2009

Intended flap thickness = 110.00 µm

©DZ Reinstein 2009

• 25% of eyes within 2 µm of the intended flap thickness

©DZ Reinstein 2009

©DZ Reinstein 2009

©DZ Reinstein 2009

90 95 100 105 110 115 120 125 130

Measured Flap Thickness

©DZ Reinstein 2009

95% within: 108-112 µm

90 95 100 105 110 115 120 125 130

Measured Flap Thickness

©DZ Reinstein 2009

95% within: 90-130 µm

90 95 100 105 110 115 120 125 130

Measured Flap Thickness

©DZ Reinstein 2009

©DZ Reinstein 2009

Required Precision: 2.5 µm

Ideal Precision: 1.66 µm

Artemis Flap Thickness

Therefore, the Artemis is capable of measuring a flap

©DZ Reinstein 2009

Artemis Flap Thickness

The Artemis is capable of measuring a flap thickness

©DZ Reinstein 2009

Cross section of the contact glass

©DZ Reinstein 2009

300 VisuMax Fast

200 reduced to ~20 seconds

Did you feel a sense of claustrophobia when the

20.0% 15.4% 16.7%

©DZ Reinstein 2009

What level of discomfort did you experience while

7.7% 8.3% 7.7%

VisuMax [12] 16.7% 41.7% 33.3% 8.3% 0.0%

©DZ Reinstein 2009

How did you feel about the length of time that

©DZ Reinstein 2009

©DZ Reinstein 2009

©DZ Reinstein 2009

©DZ Reinstein 2009

• Alternative: Ultra Thin Flap LASIK

©DZ Reinstein 2009

Thick epithelium after

Flap underneath epithelium

©DZ Reinstein 2009