LADARVision4000 CustomCornea Vs VISX CustomVue

STAR S4 IR Excimer Laser System

A Comparison of Wavefront Guided Refractive Surgery outcomes of LASIK

Disclaimer

-This presentation does not reflect the official views of the US Army, Air Force, or government -There are no financial ties to VISX or Alcon

Capt J. Richard Townley, MD Lt Col Charles D Reilly, MD

Differences between the two laser platforms

LADAR Vision CustomCornea System VISX CustomVue ™ STAR S4 IR Excimer Laser System

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Among smallest-spot beam in industry Small-Spot (<1mm) Scanning Minimized acoustic shock Depends on dilated pupil and preoperative peri-limbal demarcation to account for intraoperative cyclotorsion

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Combines advantages of larger and smaller diameter beams Minimize volume of tissue removed Smooth ablation Relies on iris registration to account for proper orientation of the preoperative wavescan for the intended treatment

Study Design Objectives:

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 Characteristics

Characteristics No. Eyes Mean Age Males Females Mean Sphere Mean Cyl Mean SE LADARVision CustomCornea 22 32.2 (22-43) 68% 31% -4.875 (-8.00 to -2.75) 0.93 (0.0 to +3.50) -4.41 (-7.60 to -2.40) VISX Custumvue 60 34.11 (22-48) 66% 33% -4.34

(-8.00 to -2.75) 0.69

(0.0 to + 2.50) -4.00

(-7.50 to -2.38) P Value 0.2173

0.3137

0.3610

100 90 80 70 60 50 40 30 20 10 0 20/15 or better 20/20 or better 20/25 or better 20/30 or better LADARVision VISX STAR 4 Characteristics #Eyes at F/U Mean Sphere Mean Cyl Mean SE LADARVision CustomCornea 22 0.166 +/- 0.33

0.222 +/- 0.33

0.11 +/- 0.19

VISX Customvue 47 -0.074 +/- 0.39

0.212 +/- 0.25

0.034 +/- 0.35

P Value 0.0172

0.9137

0.2307

100 90 80 70 60 50 40 30 20 10 0 20/15 or better Characteristics #Eyes at F/U Mean Sphere Mean Cyl Mean SE 20/20 or better 20/25 or better LADARVision CustomCornea 15 0.1875 +/- 0.73

0.0625 +/- 0.48

0.047 +/- 0.13

LADARVision VISX STAR 4 20/30 or better 20/50 or better VISX Customvue 36 -0.215 +/- 0.43

0.215 +/- 0.24

-0.083 +/- 0.33

P Value 0.1701

0.4045

0.6169

100 90 80 70 60 50 40 30 20 10 0 20/15 or better 20/20 or better 20/25 or better 20/30 or better Characteristics #Eyes at F/U Mean Sphere Mean Cyl Mean SE LADARVision CustomCornea 10 0.031 +/- 0.28

0.25 +/- 0.30

0.156 +/- 0.27

VISX Customvue 36 -0.076 +/- 0.37

0.181 +/- 0.22

-0.013 +/- 0.37

P Value 0.7074

0.5504

0.2369

LADARVision VISX STAR 4

-3 -4

Attempted SE (D)

-5

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Conclusions

One patient treated with LADAR was noted to have a small amount of micro striae post-op month three that spontaneously resolved by post-op month six. No other complications were observed in either group  This study illustrated that although the LADAR6000 was pulled from the market due to residual central islands, wavefront-guided LASIK using the Visx CustomVue system or LADARVision4000 were effective, predictable, and safe for correction of moderate to high myopic refractive errors.  One of the only notable difference was that most LADAR treatments resulted in plano to slightly hyperopic postoperative spherical equivalents while the VISX platform post-op SE had greater variation between slightly myopic and hyperopic outcomes. However these differences could be accounted for due to differences in the sample sizes between the two groups.

Future Studies

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Increased Sample Size

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Prospective Randomized Control Analysis

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Studies of Vision Quality

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Subjective Analysis with personal surveys

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Contrast Sensitivity Comparison

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Pre and Post Higher Order Aberration Comparison

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References

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