Physician Certification for CustomVue ™ Presbyopic Ablations

1. Physician Certification forCustomVue™ Presbyopic Ablations

2. CustomVue™ Presbyopic Ablations • Presbyopic corrections are enabled only in combination with CustomVue hyperopiccorrections with or without astigmatism and Iris Registration

3. CustomVue™ Presbyopic Ablations • Recommended Treatment Parameters: • Maximum WaveScan™ sphere +4.50D • Maximum WaveScan cylinder +1.50D • Maximum SE +4.50D

4. CustomVue™ Presbyopic Ablations • Presbyopic correction creates a multifocal ablation thatprovides for a pupil-based central corneal steepening of approximately 1.0 D • This central corneal steepening has a variable effect on the patient’s reading vision

5. CustomVue™ Presbyopic Ablations • Patented VISX™ multifocal ablation profile • VSS™and VRR™ablation technology used to create subtle ablation shape change to subject’s wavefront map • Central zone steepened to provide near vision • Peripheral zone targeted for distance vision

6. CustomVue™ Presbyopic Ablations • Patented VISX™ multifocal ablation profile • The combination of the pupil-size dependent central zone, the peripheral zone, and the LASIK flap produces an aspheric curve that expands the depth of focus

7. CustomVue™ Presbyopic Ablations Pre-operative Evaluation

8. CustomVue™ Presbyopic AblationsPre-operative Examination • WaveScan™ System • WaveScan exams with 6.0 mm pupils are preferred for treatments • The minimum pupil size of the wavefront-measurement must be > 5.0 mm to calculate a CustomVue treatment • Measurements with a pupil size < 5.0 mm will be unavailable for selection • Wavefront diameter captures of greater than 7.0 mm will not allow presbyopic shape creation or treatment

9. CustomVue™ Presbyopic AblationsWaveScan™ Acquisition • Users are warned to carefully monitor the wavefrontdiameter when using the presbyopia software • WaveScan measurements forpresbyopia should be done with a dark-adapted physiologic pupil • Pharmacologic pupilmanipulation is specifically NOT recommended as the treatment iscalculated as a percentage of physiologic pupil size

10. CustomVue™ Presbyopic AblationsPre-operative Examination • Contact Lens Use: • Soft contact lenses - discontinue lens wear at least two weeks prior to examination and treatment • Hard (PMMA) or RGP lenses - discontinue lens wear at least three weeks prior to examination and treatment with stable keratometry and refraction • 3 central keratometry readings and MR taken at 1 week intervals. The last two readings must not differ by > 0.5D • The WaveScan™ measurements should be stable prior to the treatment

11. CustomVue™ Presbyopic AblationsPre-operative Examination • Visual Acuity • UCVA, BSCVA • Refraction • Manifest Refraction – • Hyperopia – Pushed plus technique • Astigmatism - Jackson Cross Cylinder - maximize magnitude of cylinder

12. CustomVue™ Presbyopic AblationsPre-operative Examination • When comparing Manifest Refraction to WaveScan™ Refraction use the 4 mm diameter WaveScan data • This most closely approximates the MR

13. CustomVue™ Presbyopic AblationsPre-operative Examination Refraction Techniques • Cycloplegic Refraction (1% cyclopentolate) • True cycloplegia eliminates accommodation and allows appropriate refractive evaluation of: • Latent hyperopia • Critical in all Hyperopes

14. CustomVue™ Presbyopic AblationsPre-operative Examination • The anticipated post-operative keratometry value in any meridian must be < 50 D • To calculate the anticipated postoperative K’s add the Mean Pre-Op Keratometry to the Pre-Op MRSE • Use Manual or Auto K’s • Do not use “Sim K’s”

15. CustomVue™ Presbyopic AblationsPre-operative Examination • Keratometry • K1 is the flat K • K2 is the steep K • K2 Axis is the axis of the steep K • Pupillary Exam • Bright and dim illumination measurement • Corneal Topography - necessary in all patients • R/O Keratoconus or any other abnormality • R/O CL related abnormalities • Verify post-operative results

16. CustomVue™ Presbyopic AblationsPre-operative Examination • Slit Lamp Exam • Tonometry • Pachymetry • Ultrasonic pachymetry required for LASIK • Dilated Media and Fundus Exam

17. CustomVue™ Presbyopic Ablations Surgical Planning Surgical Technique

18. CustomVue™ Presbyopic Ablations Treatment Design Screen The Presbyopia ablation is different in LASIK vs. Surface PRK You must select LASIK or Surface PRK in the TREATMENT TYPE field

19. CustomVue™ Presbyopic Ablations Treatment Design Screen Check the ENABLE box to enable a presbyopic correction

20. CustomVue™ Presbyopic AblationsEnvironmental Conditions • CustomVue Presbyopic procedures are done with Variable Spot Scanning (VSS™) and Variable Repetition Rate (VRR™) • Even though the repetition rate varies from 6 to 20 Hz these treatments tend to be longer in duration than myopic treatments • It is important to pay careful attention to environmental conditions

21. CustomVue™ Presbyopic AblationsEnvironmental Conditions • Control of environmental conditions during CustomVue treatments is important. In previous U.S. FDA Multi-Center Clinical Trials, the room conditions were: • Temperature ranged from 68ºF to 72ºF (20ºC to 22.2ºC) • Relative humidity ranged from 40% to 45% • Treatments performed at >75º were associated with less accurate outcomes • Stability of temperature and humidity is important

22. Iris pattern is unique to each eye IR aligns the preoperative WaveScan™ System and intra-operative STAR S4 IR™ System iris images CustomVue™ Presbyopic AblationsIris Registration

23. As the pupil changes size, its centroid may not remain stationary, relative to the outer iris boundary CustomVue™ Presbyopic AblationsIris Registration LVC Treatment (photopic) Diagnostic measurement (mesopic) Outer Iris Boundary For International Use Only

24. CustomVue™ Presbyopic AblationsIris Registration (IR) • IR is a critically important component of Presbyopia treatments • Proper registration of wavefront-guided ablation • Proper placement of the pupil-size dependent central zone relative to the pupil centroid

25. CustomVue™ Hyperopia Surgical Technique • Do not use a Chayet drain or similar device • Create and lift flap • Align limbal marks with reticle hash marks • Dry exposed stromal bed if there is fluid accumulation • Perform ablation • Interrupt ablation only if there is fluid accumulation • Replace flap

26. VISX™Hyperopic Presbyopia Completion of Certification Acknowledgement of Understanding: By checking the box below, I acknowledge I have read and understood this material