LADARVision4000 LADARVision4000 Vs Vs VISX VISX CustomVueCustomVue

CustomCorneaCustomCornea

A Comparison of Wavefront Guided A Comparison of Wavefront Guided

Refractive Surgery outcomes of LASIKRefractive Surgery outcomes of LASIKCapt J. Richard Townley, MDCapt J. Richard Townley, MDLt Col Charles D Reilly, MDLt Col Charles D Reilly, MD

STAR S4 IR Excimer Laser STAR S4 IR Excimer Laser SystemSystem

DisclaimerDisclaimer-This presentation does not reflect the official views of the US Army, Air -This presentation does not reflect the official views of the US Army, Air

Force, or governmentForce, or government-There are no financial ties to VISX or Alcon -There are no financial ties to VISX or Alcon

Among smallest-spot beam Among smallest-spot beam in industry in industry

Small-Spot (<1mm) Scanning

Minimized acoustic shockMinimized acoustic shock Depends on dilated pupil Depends on dilated pupil

and preoperative peri-and preoperative peri-limbal demarcation to limbal demarcation to account for intraoperative account for intraoperative cyclotorsioncyclotorsion

Differences between the two laser platformsLADARLADARVision Vision

CustomCornea SystemCustomCornea System

VISX CustomVueVISX CustomVue™™

STAR S4 IR Excimer Laser STAR S4 IR Excimer Laser SystemSystem

Combines advantages of Combines advantages of larger and smaller larger and smaller diameter beamsdiameter beams

Minimize volume of tissue Minimize volume of tissue removedremoved

Smooth ablationSmooth ablation Relies on iris registration Relies on iris registration

to account for proper to account for proper orientation of the orientation of the preoperative wavescan for preoperative wavescan for the intended treatmentthe intended treatment

Study DesignStudy DesignObjectives: To analyze the US Air Force Warfighter Refractory Surgery program to determine whether there was a difference in treatment outcomes between wavefront-guided LASIK performed with LADARVision4000 CustomCornea vs. VISX CustomVue. Methods: This study analyzed over 8,000 eyes that had undergone refractive surgery by the USAF over the past 8 yrs. Out of those 8000 eyes 936 had received custom Lasik treatments on either the VISX or LADAR4000 platforms. Since the vast majority of those eyes were treated with VISX, the 22 eyes that had been treated on LADAR were closely matched for age, gender, and pre-op refractive errors with those treated with VISX. All patients included in the study were operated on by the same surgeon and used the same keratome. Each of the eyes that were treated were followed up at 1, 3, and 6 months after surgery and the outcomes that were compared between the two laser platforms based on their uncorrected visual acuity (UCVa), best corrected visual acuity (BCVa), manifested refractions (MRx), and any documented complications.

Preoperative Patient Preoperative Patient CharacteristicsCharacteristics

CharacteristCharacteristicsics

LADARVisionLADARVision

CustomCorneaCustomCorneaVISX VISX

CustumvueCustumvueP ValueP Value

No. EyesNo. Eyes 2222 6060

Mean AgeMean Age 32.2 (22-43)32.2 (22-43) 34.11 (22-48)34.11 (22-48)

MalesMales 68%68% 66%66%

FemalesFemales 31%31% 33%33%

Mean Mean SphereSphere

-4.875 (-8.00 to -2.75)

-4.34-4.34

(-8.00 to -2.75)(-8.00 to -2.75)0.21730.2173

Mean CylMean Cyl 0.93 (0.0 to +3.50)

0.690.69

(0.0 to + 2.50)(0.0 to + 2.50)0.31370.3137

Mean SEMean SE -4.41 (-7.60 to -2.40)

-4.00-4.00

(-7.50 to -2.38)(-7.50 to -2.38)0.36100.3610

1 Month Results1 Month Results1 Month Uncorrected VA

0

10

20

30

40

50

60

70

80

90

100

20/15 or better 20/20 or better 20/25 or better 20/30 or better

Per

cen

t

LADARVision

VISX STAR 4

CharacteristicsCharacteristics LADARVision LADARVision CustomCorneaCustomCornea

VISX VISX

CustomvueCustomvueP ValueP Value

#Eyes at F/U#Eyes at F/U 22 4747

Mean SphereMean Sphere 0.166 +/- 0.33 -0.074 -0.074 +/- 0.39 0.01720.0172

Mean CylMean Cyl 0.222 +/- 0.33

0.2120.212 +/- 0.25 0.91370.9137

Mean SEMean SE 0.11 +/- 0.19

0.034 0.034 +/- 0.35

0.23070.2307

3 Months Results3 Months Results3 Months Uncorrected VA

0

10

20

30

40

50

60

70

80

90

100

20/15 orbetter

20/20 orbetter

20/25 orbetter

20/30 orbetter

20/50 orbetter

Per

cen

t

LADARVision

VISX STAR 4

CharacteristicsCharacteristics LADARVision LADARVision CustomCorneaCustomCornea

VISX VISX

CustomvueCustomvueP ValueP Value

#Eyes at F/U#Eyes at F/U 15 3636

Mean SphereMean Sphere 0.1875 +/- 0.73 -0.215 -0.215 +/- 0.43 0.17010.1701

Mean CylMean Cyl 0.0625 +/- 0.48 0.2150.215 +/- 0.24 0.40450.4045

Mean SEMean SE 0.047 +/- 0.13 -0.083 -0.083 +/- 0.33 0.61690.6169

6 Months6 Months6 M onths Uncorrected VA

0

10

20

30

40

50

60

70

80

90

100

20/15 or better 20/20 or better 20/25 or better 20/30 or better

Pe

rce

nt

LADARVis ion

VISX STAR 4

CharacteristicsCharacteristics LADARVision LADARVision CustomCorneaCustomCornea

VISX VISX

CustomvueCustomvueP ValueP Value

#Eyes at F/U#Eyes at F/U 10 3636

Mean SphereMean Sphere 0.031 +/- 0.28 -0.076 -0.076 +/- 0.37 0.70740.7074

Mean CylMean Cyl 0.25 +/- 0.30 0.1810.181 +/- 0.22 0.55040.5504

Mean SEMean SE 0.156 +/- 0.27 -0.013 -0.013 +/- 0.37

0.23690.2369

Which Laser Platform Which Laser Platform Achieved the Attempted Achieved the Attempted

Treatment?Treatment?Surgical Correction of Refractive Error After 6 Months

y = 1.0641x + 0.4176

R2 = 0.9782

y = 1.0318x + 0.1323

R2 = 0.9266

-9

-8

-7

-6

-5

-4

-3

-2

-1

0

-8-7-6-5-4-3-2-10Attempted SE (D)

Ach

ieve

d S

E (

D)

LADARVision

VISX STAR 4

Linear (LADARVision)

Linear (VISX STAR 4)

ConclusionsConclusions One patient treated with LADAR was noted to have a One patient treated with LADAR was noted to have a

small amount of micro striae post-op month three that small amount of micro striae post-op month three that spontaneously resolved by post-op month six. No other spontaneously resolved by post-op month six. No other complications were observed in either groupcomplications were observed in either group

This study illustrated that although the LADAR6000 was This study illustrated that although the LADAR6000 was pulled from the market due to residual central islands, pulled from the market due to residual central islands, wavefront-guided LASIK using the Visx CustomVue wavefront-guided LASIK using the Visx CustomVue system or LADARVision4000 were effective, predictable, system or LADARVision4000 were effective, predictable, and safe for correction of moderate to high myopic and safe for correction of moderate to high myopic refractive errors. refractive errors.

One of the only notable difference was that most LADAR One of the only notable difference was that most LADAR treatments resulted in plano to slightly hyperopic treatments resulted in plano to slightly hyperopic postoperative spherical equivalents while the VISX postoperative spherical equivalents while the VISX platform post-op SE had greater variation between platform post-op SE had greater variation between slightly myopic and hyperopic outcomes. However these slightly myopic and hyperopic outcomes. However these differences could be accounted for due to differences in differences could be accounted for due to differences in the sample sizes between the two groups.the sample sizes between the two groups.

Future StudiesFuture Studies Increased Sample SizeIncreased Sample Size

Prospective Randomized Control Prospective Randomized Control AnalysisAnalysis

Studies of Vision QualityStudies of Vision Quality Subjective Analysis with personal surveysSubjective Analysis with personal surveys Contrast Sensitivity ComparisonContrast Sensitivity Comparison Pre and Post Higher Order Aberration Pre and Post Higher Order Aberration

ComparisonComparison

ReferencesReferences Awwad ST et al. Wavefront-guided laser in situ keratomileusis with Alcon CustomCornea

and VISX CustomVue: three-month results. J Refract Surg. 2004; 20 606-613

Michael D. et.al. A Prospective Randomized Clinical Trial of Laser In Situ Keratomileusis With Two Different Lasers Am. J. Ophthalmol -01-AUG-2005; 140(2): 173.1-11

Michael S. et al. Comparison of LADARVision and Visx Star S3 laser in situ keratomileuisis outcomes in myopia and hyperopia. J Cataract Refract Surg 01-DEC 2003; 29: 2351-6

Raymond P. G. et.al. Comparison of LASIK outcomes with Alcon LADARVision4000 and the VISX STAR S2 Excimer Laser Using Optimized Nomograms. J Refract Surg. NOV 2005; 21: 683-690

Sale et. al. Contralateral comparison of Alcon CustomCornea and VISX CustomVue wavefront-guided laser in situ keratomileusis: one-month results. J Refract Surg. 2004; 20: 601-605

Shady T. et. al. Wavefront-Guided LASIK for Myopia Using the LADAR CustomCornea and the VISX CustomVue. J Refract Surg JAN 2007; 23: 26-38

Seiler T et al. Myopic photorefractive keratectomy with the excimer laser. One-year follow-up. Ophthalmology, 1991; 98:1156-1163

Seward MS et. al. Comparison of LADARVision and VISX Star S3 laser in situ keratomileusis outcomes in myopia and hyperopia. J Cataract Refract Surg. 2003; 292351-2357

Tobaigy FM. A control-matched comparison of laser epithelial keratomileusis and laser in situ keratomileusis for low to moderate myopia.  Am J Ophthalmol - 01-DEC-2006; 142(6): 901-8