1 / 26

Physician Certification for CustomVue ™ Presbyopic Ablations

Physician Certification for CustomVue ™ Presbyopic Ablations. CustomVue ™ Presbyopic Ablations. Presbyopic corrections are enabled only in combination with CustomVue hyperopic corrections with or without astigmatism and Iris Registration. CustomVue ™ Presbyopic Ablations.

bernad
Download Presentation

Physician Certification for CustomVue ™ Presbyopic Ablations

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related