Bausch & Lomb Zyoptix LASIK System - University Of Houston

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BauschBausch && LombLombZyoptixZyoptix LASIKLASIK SystemSystemScott MacRae M.D.StrongVision,Department of Ophthalmology,University of Rochester

Acknowledgements: Dan Durrie M.D.Steve Slade MDIan Cox PhD.

Features Correction of Preoperative WavefrontAberration up to 5th Order Improved Large Pupil VisualPerformance Increased Optic Zone Compared toConventional Ablation Procedure

OrbScanIIzOrbScan IIzCornealarchitectureCorneal architectureZylinkZylink GenerationofoptimizedGeneration of optimizedLaserLaser TreatmentTreatmentZywaveZywave IIII AberrometerAberrometerCompleteWavefrontComplete Wavefront AnalysisAnalysisHansatomeHansatome KeratomeKeratomeLaserLaser SystemSystem 217z217z

Wavefront Aberration Results:Large Sample ZyoptixCustomized LASIK

Parameters Refraction and Visual Acuity data from 340eyes at Preop, 1D,1W, 1M, 3M, 6M visits Bilateral Zyoptix Procedures Up to –7.00D Sphere & -3.50D Cylinder Cumulative data from 3 sites No Nomogram adjustments used

Refractive Status - Manifest Sphere & .620.370.370.350.350.330.330.320.320.320.32

Preop Higher Order RMS vs WavefrontAperture Diameter (n 340)7.0mm – 0.8 RMS (280% )6.0mm - 0.42 RMS (90% )5.0mm - 0.22 RMS

Zyoptix Spherical Equivalent Over fest-4.5-4.5-4.0-4.0nn Months

Zyoptix Sph. Equivalent Accuracy & Precision-9PostopActual: (Preop SE - 6M Postop SE (D))-8 /-0.50D /-1.00D6 Months75.9%93.8%-7-6-5-4-3-26 Month PostopNo Nomogram Adjustment-100-1-2-3-4-5-6-7Expected: Preop Manifest Subjective Spherical Equivalent (D)-8-9

Wavefront Aberration

Pre Op Higher Order Aberration Categorized By Zernike Order1.2Wavefront Aberration Root Mean Square RMS (um)n 3091.00.80.60.40.20.03rd Order RMS Preop5th Order RMS Preop4th Order RMS PreopMean SDMin-Max

Change in 3rd Order RMS from PreopCategorizedCategorized byby PreopPreop HigherHigher OrderOrder RMSRMSChange in 3rd Order RMS from Preop (Avg. Over Visits) - um0.3n 42n 179n 770.2n 90.1n 269%0.0-0.1-0.2-0.3-0.4-0.5-0.6-0.7p Preoperative Higher Order RMS1.00-1.24um

Change in 4th Order RMS from PreopCategorizedCategorized byby PreopPreop HigherHigher OrderOrder RMSRMSChange in 4th Order RMS from Preop (Avg Over Visits) -um0.4n 42n 179n 77n 9n m0.50-0.74um0.75-0.99umPreoperative Higher Order RMS1.00-1.24um

Biomechanics StudyChange in Spherical Aberration – Flap then LASIK6 mm pupilMicrons of Aberration, or Z40 (µm)0.2Flap Only2 monthsAblation0.10Pre-0D N 17Pre-1D16Pre-1W17Pre-1M17Pre-2M15Pre-1DLSK 16Pre-1WLSK 15Pre-1MLSK 15-0.1“Positive”S. Aberration”-0.2-0.320min. 1DPO1W1M2M 1DLSK1MLSK1WLSKCondition0Z4

Change in 5th Order RMS from PreopCategorizedCategorized byby PreopPreop HigherHigher OrderOrder RMSRMSChange in 5th Order RMS from Preop (Avg. Over Visits) - um0.4n 42n 9n 77n 179n m0.50-0.74um0.75-0.99umPreop Higher Order RMS1.00-1.24um

Change in Higher Order RMS from PreopCategorizedCategorized byby PreopPreop HigherHigher OrderOrder RMSRMSChange in HORMS from Preop (Avg. Over Visits) - um0.40.3n 42n 179n 77n 90.2n 247%0.10.0-0.1-0.2-0.3-0.4-0.5-0.6Pupil Diameter 6.0mmp Preoperative Higher Order RMS1.00-1.24um

Visual Acuity andVision Performance

Uncorrected logMAR Visual Acuity- 6M Postop - All Eyes (n 91.5% EyesAchieved20/20 220/3220/4020/40 20/40 020/2520/25

Postop UCVA Greater Than or Equal toPreop BCVA- All Eyes (n 340)11 DayDay PostopPostop11 WeekWeek PostopPostop11 MonthMonth PostopPostop33 MonthsMonths PostopPostop66 MonthsMonths 1%78.3%78.3%

Best Corrected logMAR Visual Acuity- 6M Postop - All Eyes (n 009090808070706M6MPostopPostop99.499.488.3% EyesAchieved20/16 /2020/2020/2520/2520/3220/32

Change in Best Corrected logMAR Visual Acuity- 6M Postop - All Eyes (n 340)4541.5Percentage of Eyes4061% EyesShowed anIncrease of1 line orGreater33.835302517.4201510505.31.50.6 -2-1012Change in Lines of Acuity3

% of Patients with Clinically Significant Change inContrast Sensitivity at 6M PostopEyesEyes 0.30 %71.0%4.1%4.1%22.1% of Eyes Showed anIncrease in ContrastSensitivity Over PreopUnder Low HTIME)22.1%22.1%75.9%75.9%2.1%2.1%

Light SensitivityHeadachesPainRednessDrynessExcessive TearingBurningGrittinessGlareHalosBlurry VisionDouble VisionGhost ImagesFluctuation in VisionBright Light VisionNormal Light VisionDim Light VisionDifficulties with NightDrivingPATIENT SYMPTOMS:Better Than Preop36.8% (125)25.3% (86)6.2% (21)23.2% (79)19.7% (79)12.1% (41)14.4% (49)8.5% (29)20.9% (71)13.5% (46)22.4% (76)1.5% (5)4.4% (15)7.5% (25)23.9% (81)9.4% (32)25.4% (86)40.3% (137)PostPostopopBetterBetter6 Months PostopWorse Than Preop7.6% (26)5.3% (18)2.1% (7)10.9% (37)31.2% (106)3.8% (13)7.9% (27)6.2% (21)15.3% (52)14.4% (49)18.5% (63)3.2% (11)4.4% (15)24.2% (81)10.6% (36)11.2% (38)17.4% (59)10.3% (35)NoNoDifferenceDifferencep-value 0.001 0.0010.008 0.0010.003 0.0010.0120.2580.0870.7580.2700.1341.000 0.001 0.0010.4730.025 0.001PreopPreopBetterBetter

Self Evaluation at 6 Months PostopQuality of Vision After Surgery?% (n)No Improvement0.3% (1)Slight Improvement1.2% (4)Moderate Improvement1.8% (6)Marked Improvement12.1% (41)Extreme Improvement84.7% (288)

Self Evaluation at 6 Months PostopSatisfaction with Surgery?Very Satisfied% (n)90.9% (309)Moderately Satisfied7.9% (27)Neutral1.2% (4)Dissatisfied0% (0)Very Dissatisfied0% (0)

Conclusion Zyoptix Provides Excellent Sphere and CylinderCorrection Zyoptix Shows a Reduction in Higher OrderAberrations In Those Patients with SubstantialPreoperative Higher Order Aberrations Zyoptix Provides Acceptable Visual Acuity andVisual Performance Outcomes

Change in Spherical Aberration - Flap then LASIK Pre-0D N 17 Pre-1D 16 Pre-1W 17 Pre-1M 17 Pre-2M 15 Pre-1DLSK 16 Pre-1WLSK 15 Pre-1MLSK 15 Z4 Microns of Aberration, or Z40 (µm) 0 6 mm pupil Condition 20min. PO 1D 1W 1M 2M 1DLSK 1WLSK 1MLSK-0.3-0.2-0.1 0 0.1 0.2 Ablation Flap Only 2 months "Positive" S. Aberration"

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