Design the Progressive Hard Contact Lens for Myopic Presbyopic
Physician Certification for CustomVue ™ Presbyopic Ablations.
-
Upload
rosalind-bryan -
Category
Documents
-
view
223 -
download
0
Transcript of Physician Certification for CustomVue ™ Presbyopic Ablations.
Physician Physician Certification Certification
forforCustomVueCustomVue™™
Presbyopic AblationsPresbyopic Ablations
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations
Presbyopic corrections are Presbyopic corrections are enabled only in combination with enabled only in combination with CustomVue CustomVue hyperopichyperopic corrections corrections with or without astigmatism and with or without astigmatism and Iris RegistrationIris Registration
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations
Recommended Treatment Recommended Treatment Parameters:Parameters:– Maximum WaveScanMaximum WaveScan™™ sphere sphere ++4.504.50DD– Maximum WaveScan cylinder Maximum WaveScan cylinder ++1.501.50DD– Maximum SEMaximum SE ++44..5050DD
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations
Presbyopic correction creates a Presbyopic correction creates a multifocal ablation that provides for a multifocal ablation that provides for a pupil-based central corneal steepening pupil-based central corneal steepening of approximately 1.0 Dof approximately 1.0 D
This central corneal steepening has a This central corneal steepening has a variable effect on the patient’s reading variable effect on the patient’s reading visionvision
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblationsCustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations
Patented VISX™ multifocal ablation profile
VSS™ and VRR™ ablation technology used to create subtle ablation shape change to subject’s wavefront mapCentral zone steepened to provide near
visionPeripheral zone targeted for distance vision
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblationsCustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations
Patented VISX™ multifocal ablation profileThe 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
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations
Pre-operative Pre-operative EvaluationEvaluation
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations
Pre-operative Pre-operative EvaluationEvaluation
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Pre-operative ExaminationPre-operative Examination WaveScanWaveScan™™ System System
– WaveScan exams with 6.0 mm pupils WaveScan exams with 6.0 mm pupils are preferred for treatmentsare preferred for treatments The minimum pupil size of the wavefront-The minimum pupil size of the wavefront-
measurement must be > 5.0 mm to measurement must be > 5.0 mm to calculate a CustomVue treatmentcalculate a CustomVue treatment
Measurements with a pupil size < 5.0 mm Measurements with a pupil size < 5.0 mm will be unavailable for selectionwill be unavailable for selection
Wavefront diameter captures of greater Wavefront diameter captures of greater than 7.0 mm will not allow presbyopic than 7.0 mm will not allow presbyopic shape creation or treatmentshape creation or treatment
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations WaveScanWaveScan™™ Acquisition Acquisition Users are warned to carefully monitor
the wavefront diameter when using the presbyopia software
WaveScan 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
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Pre-operative ExaminationPre-operative Examination Contact Lens Use:Contact Lens Use:
– Soft contact lenses - discontinue lens wear Soft contact lenses - discontinue lens wear at least at least twotwo weeks prior to examination weeks prior to examination andand treatment treatment
– Hard (PMMA) or RGP lenses - discontinue Hard (PMMA) or RGP lenses - discontinue lens wear at least lens wear at least threethree weeks prior to weeks prior to examination examination andand treatment with stable treatment with stable keratometry and refractionkeratometry and refraction
3 central keratometry readings and MR taken at 3 central keratometry readings and MR taken at 1 week intervals. The last two readings must not 1 week intervals. The last two readings must not differ by > 0.5Ddiffer by > 0.5D
– The WaveScanThe WaveScan™™ measurements should be measurements should be stable prior to the treatmentstable prior to the treatment
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Pre-operative ExaminationPre-operative Examination
Visual AcuityVisual Acuity– UCVA, BSCVAUCVA, BSCVA
Refraction Refraction – Manifest Refraction – Manifest Refraction –
Hyperopia – Pushed plus techniqueHyperopia – Pushed plus technique Astigmatism - Jackson Cross Cylinder - Astigmatism - Jackson Cross Cylinder -
maximize magnitude of cylindermaximize magnitude of cylinder
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Pre-operative ExaminationPre-operative Examination When comparing Manifest Refraction When comparing Manifest Refraction
to WaveScanto WaveScan™™ Refraction use the 4 Refraction use the 4 mm diameter WaveScan datamm diameter WaveScan data– This most closely approximates the MRThis most closely approximates the MR
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Pre-operative ExaminationPre-operative Examination
Refraction TechniquesRefraction Techniques Cycloplegic Refraction (1% Cycloplegic Refraction (1%
cyclopentolate)cyclopentolate) True cycloplegia eliminates True cycloplegia eliminates
accommodation and allows appropriate accommodation and allows appropriate refractive evaluation of:refractive evaluation of:– Latent hyperopiaLatent hyperopia
Critical in all Hyperopes Critical in all Hyperopes
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Pre-operative ExaminationPre-operative Examination The anticipated post-operative The anticipated post-operative
keratometry value in any meridian must keratometry value in any meridian must be be << 50 D 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”
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Pre-operative ExaminationPre-operative Examination KeratometryKeratometry
– K1 is the flat KK1 is the flat K– K2 is the steep KK2 is the steep K– K2 Axis is the axis of the steep KK2 Axis is the axis of the steep K
Pupillary ExamPupillary Exam– Bright and dim illumination measurementBright and dim illumination measurement
Corneal Topography - Corneal Topography - necessarynecessary in all in all patientspatients– R/O Keratoconus or any other abnormalityR/O Keratoconus or any other abnormality– R/O CL related abnormalitiesR/O CL related abnormalities– Verify post-operative resultsVerify post-operative results
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Pre-operative ExaminationPre-operative Examination
Slit Lamp ExamSlit Lamp Exam TonometryTonometry PachymetryPachymetry
– Ultrasonic pachymetry required for Ultrasonic pachymetry required for LASIK LASIK
Dilated Media and Fundus ExamDilated Media and Fundus Exam
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations
Surgical PlanningSurgical PlanningSurgical TechniqueSurgical Technique
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations
Surgical PlanningSurgical PlanningSurgical TechniqueSurgical Technique
CustomVue™ Presbyopic CustomVue™ Presbyopic Ablations Ablations Treatment Design ScreenTreatment Design Screen
You must select LASIK or Surface PRK in You must select LASIK or Surface PRK in the the
TREATMENT TYPE fieldTREATMENT TYPE field
The Presbyopia ablation is differentThe Presbyopia ablation is different in LASIK vs. Surface PRKin LASIK vs. Surface PRK
CustomVueCustomVue™™ Presbyopic Presbyopic Ablations Ablations Treatment Design ScreenTreatment Design Screen
Check the Check the ENABLE ENABLE box to enable box to enable a presbyopic correctiona presbyopic correction
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Environmental ConditionsEnvironmental Conditions
CustomVue CustomVue Presbyopic Presbyopic procedures are procedures are done with Variable Spot Scanning done with Variable Spot Scanning (VSS(VSS™™) and Variable Repetit) and Variable Repetitiion Rate on Rate (VRR(VRR™™))– Even though the repetition rate varies from Even though the repetition rate varies from
6 to 20 Hz these treatments tend to be 6 to 20 Hz these treatments tend to be longer in duration than myopic treatmentslonger in duration than myopic treatments
It is important to pay careful attention It is important to pay careful attention to environmental conditionsto environmental conditions
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Environmental ConditionsEnvironmental Conditions Control of environmental conditions during Control of environmental conditions during
CustomVue treatments is important. In previous CustomVue treatments is important. In previous U.S. FDA Multi-Center Clinical Trials, the room U.S. FDA Multi-Center Clinical Trials, the room conditions were:conditions were:– Temperature ranged from 68ºF to 72ºFTemperature ranged from 68ºF to 72ºF (20 (20ººC to 22.2C to 22.2ººC)C)– Relative humidity ranged from 40% to 45%Relative humidity ranged from 40% to 45%– Treatments performed at Treatments performed at >>75º were associated with less 75º were associated with less
accurate outcomesaccurate outcomes Stability of temperature and humidity is importantStability of temperature and humidity is important
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Iris Registration
Iris pattern is Iris pattern is unique to each unique to each eyeeye
IR aligns the IR aligns the preoperative preoperative WaveScanWaveScan™™ System and intra-System and intra-operative STAR S4 operative STAR S4 IRIR™™ System iris System iris imagesimages
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblations Iris Registration
Diagnostic measurement (mesopic)Diagnostic measurement (mesopic) LVC Treatment (photopic)LVC Treatment (photopic)
As the pupil changes size, its centroid may not remain stationary, relative to the As the pupil changes size, its centroid may not remain stationary, relative to the outer iris boundaryouter iris boundary
Outer Iris BoundaryOuter Iris BoundaryFor International Use Only
CustomVueCustomVue™™ Presbyopic Presbyopic AblationsAblationsIris Registration (IR)
IR is a critically important IR is a critically important component of Presbyopia component of Presbyopia treatmentstreatments– Proper registration of wavefront-Proper registration of wavefront-
guided ablationguided ablation– Proper placement of the pupil-size Proper placement of the pupil-size
dependent central zone relative to dependent central zone relative to the pupil centroidthe pupil centroid
CustomVueCustomVue™™ Hyperopia Hyperopia Surgical TechniqueSurgical Technique
Do not use a Chayet drain or similar device Do not use a Chayet drain or similar device Create and lift flapCreate and lift flap Align limbal marks with reticle hash marksAlign limbal marks with reticle hash marks Dry exposed stromal bed if there is fluid Dry exposed stromal bed if there is fluid
accumulationaccumulation Perform ablationPerform ablation Interrupt ablation only if there is fluid Interrupt ablation only if there is fluid
accumulationaccumulation Replace flapReplace flap
VISXVISX™ ™ Hyperopic Hyperopic Presbyopia Completion Presbyopia Completion of Certificationof Certification
Acknowledgement of Understanding:Acknowledgement of Understanding:
By checking the box below, I By checking the box below, I acknowledge I have read and acknowledge I have read and
understood this materialunderstood this material