1. LADARVision4000 Vs VISX CustomVue LADARVision4000 Vs VISX CustomVue CustomCornea CustomCornea A Comparison of Wavefront Guided Refractive Surgery outcomes of LASIK Capt J. Richard Townley, MD Lt Col Charles D Reilly, MD STAR S4 IR Excimer Laser System 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

2. Among smallest-spot beam in industry Among smallest-spot beam in industry Small-Spot (<1mm) Scanning Minimized acoustic shock Minimized acoustic shock Depends on dilated pupil and preoperative peri-limbal demarcation to account for intraoperative cyclotorsion Depends on dilated pupil and preoperative peri-limbal demarcation to account for intraoperative cyclotorsion Differences between the two laser platforms LADARVision CustomCornea System VISX CustomVue ™ STAR S4 IR Excimer Laser System Combines advantages of larger and smaller diameter beams Combines advantages of larger and smaller diameter beams Minimize volume of tissue removed Minimize volume of tissue removed Smooth ablation Smooth ablation Relies on iris registration to account for proper orientation of the preoperative wavescan for the intended treatment Relies on iris registration to account for proper orientation of the preoperative wavescan for the intended treatment

3. 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.

4. Preoperative Patient Characteristics CharacteristicsLADARVisionCustomCorneaVISXCustumvue P Value No. Eyes 2260 Mean Age 32.2 (22-43) 34.11 (22-48) Males68%66% Females31%33% Mean Sphere -4.875 (-8.00 to -2.75)-4.34 0.2173 Mean Cyl 0.93 (0.0 to +3.50)0.69 (0.0 to + 2.50) 0.3137 Mean SE -4.41 (-7.60 to -2.40)-4.00 (-7.50 to -2.38) 0.3610

5. 1 Month Results Characteristics LADARVision CustomCornea VISXCustomvue P Value #Eyes at F/U 2247 Mean Sphere 0.166 +/- 0.33 -0.074 -0.074 +/- 0.390.0172 Mean Cyl 0.222 +/- 0.33 0.212 0.212 +/- 0.250.9137 Mean SE 0.11 +/- 0.19 0.034 0.034 +/- 0.350.2307

6. 3 Months Results Characteristics LADARVision CustomCornea VISXCustomvue P Value #Eyes at F/U 1536 Mean Sphere 0.1875 +/- 0.73 -0.215 -0.215 +/- 0.430.1701 Mean Cyl 0.0625 +/- 0.48 0.215 0.215 +/- 0.240.4045 Mean SE 0.047 +/- 0.13 -0.083 -0.083 +/- 0.330.6169

7. 6 Months Characteristics LADARVision CustomCornea VISXCustomvue P Value #Eyes at F/U 1036 Mean Sphere 0.031 +/- 0.28 -0.076 -0.076 +/- 0.370.7074 Mean Cyl 0.25 +/- 0.30 0.181 0.181 +/- 0.220.5504 Mean SE 0.156 +/- 0.27 -0.013 -0.013 +/- 0.370.2369

8. Which Laser Platform Achieved the Attempted Treatment?

9. 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 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. 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. 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.

10. Future Studies Increased Sample Size Increased Sample Size Prospective Randomized Control Analysis Prospective Randomized Control Analysis Studies of Vision Quality Studies of Vision Quality Subjective Analysis with personal surveys Subjective Analysis with personal surveys Contrast Sensitivity Comparison Contrast Sensitivity Comparison Pre and Post Higher Order Aberration Comparison Pre and Post Higher Order Aberration Comparison

11. 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