Physician Certification for Custom Vue Presbyopic Ablations Custom

Physician Certification for Custom. Vue™ Presbyopic Ablations

Custom. Vue™ Presbyopic Ablations n Presbyopic corrections are enabled only in combination with Custom. Vue hyperopic corrections with or without astigmatism and Iris Registration

Custom. Vue™ Presbyopic Ablations n Recommended Treatment Parameters: – Maximum Wave. Scan™ sphere – Maximum Wave. Scan cylinder – Maximum SE +4. 50 D +1. 50 D +4. 50 D

Custom. Vue™ Presbyopic Ablations n Presbyopic correction creates a multifocal ablation that provides for a pupil-based central corneal steepening of approximately 1. 0 D n This central corneal steepening has a variable effect on the patient’s reading vision

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

Custom. Vue™ Presbyopic Ablations l Patented profile l The VISX™ multifocal ablation 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

™ Custom. Vue Presbyopic Ablations Pre-operative Evaluation

Custom. Vue™ Presbyopic Ablations Pre-operative Examination n Wave. Scan™ System – Wave. Scan exams with 6. 0 mm pupils are preferred for treatments n The minimum pupil size of the wavefrontmeasurement must be > 5. 0 mm to calculate a Custom. Vue treatment n Measurements with a pupil size < 5. 0 mm will be unavailable for selection n Wavefront diameter captures of greater than 7. 0 mm will not allow presbyopic shape creation or treatment

Custom. Vue™ Presbyopic Ablations Wave. Scan™ Acquisition n Users are warned to carefully monitor the wavefront diameter when using the presbyopia software Wave. Scan measurements for presbyopia should be done with a dark-adapted physiologic pupil Pharmacologic pupil manipulation is specifically NOT recommended as the treatment is calculated as a percentage of physiologic pupil size

Custom. Vue™ Presbyopic Ablations Pre-operative Examination n 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 n 3 central keratometry readings and MR taken at 1 week intervals. The last two readings must not differ by > 0. 5 D – The Wave. Scan™ measurements should be stable prior to the treatment

Custom. Vue™ Presbyopic Ablations Pre-operative Examination n Visual Acuity – UCVA, BSCVA n Refraction – Manifest Refraction – n Hyperopia – Pushed plus technique n Astigmatism - Jackson Cross Cylinder maximize magnitude of cylinder

Custom. Vue™ Presbyopic Ablations Pre-operative Examination n When comparing Manifest Refraction to Wave. Scan™ Refraction use the 4 mm diameter Wave. Scan data – This most closely approximates the MR

Custom. Vue™ Presbyopic Ablations Pre-operative Examination Refraction Techniques n n Cycloplegic Refraction (1% cyclopentolate) True cycloplegia eliminates accommodation and allows appropriate refractive evaluation of: – Latent hyperopia n Critical in all Hyperopes

Custom. Vue™ Presbyopic Ablations Pre-operative Examination n The anticipated post-operative keratometry value in any meridian must be < 50 D n 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”

Custom. Vue™ Presbyopic Ablations Pre-operative Examination n Keratometry – – – n K 1 is the flat K K 2 is the steep K K 2 Axis is the axis of the steep K Pupillary Exam – Bright and dim illumination measurement n Corneal Topography - necessary in all patients – R/O Keratoconus or any other abnormality – R/O CL related abnormalities – Verify post-operative results

Custom. Vue™ Presbyopic Ablations Pre-operative Examination Slit Lamp Exam n Tonometry n Pachymetry n – Ultrasonic pachymetry required for LASIK n Dilated Media and Fundus Exam

™ Custom. Vue Presbyopic Ablations Surgical Planning Surgical Technique

Custom. Vue™ 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

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

Custom. Vue™ Presbyopic Ablations Environmental Conditions n Custom. Vue 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 n It is important to pay careful attention to environmental conditions

Custom. Vue™ Presbyopic Ablations Environmental Conditions n Control of environmental conditions during Custom. Vue 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 n Stability of temperature and humidity is important

Custom. Vue™ Presbyopic Ablations Iris Registration n n Iris pattern is unique to each eye IR aligns the preoperative Wave. Scan™ System and intra-operative STAR S 4 IR™ System iris images

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

Custom. Vue™ Presbyopic Ablations Iris Registration (IR) n 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

Custom. Vue™ Hyperopia Surgical Technique n n n n 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

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