Physician Certification for CustomVue Presbyopic Ablations

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Physician Certification forCustomVue
Presbyopic Ablations
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CustomVue Presbyopic Ablations

• Presbyopic corrections are enabled only in
  combination with CustomVue hyperopic corrections
  with or without astigmatism and Iris Registration

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CustomVue Presbyopic Ablations

• Recommended Treatment Parameters
• Maximum WaveScan sphere 4.50D
• Maximum WaveScan cylinder 1.50D
• Maximum SE 4.50D

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CustomVue Presbyopic Ablations

• Presbyopic correction creates a multifocal
  ablation that provides for a pupil-based central
  corneal steepening of approximately 1.0 D
• This central corneal steepening has a variable
  effect on the patients reading vision

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CustomVue Presbyopic Ablations

• Patented VISX multifocal ablation profile
• VSS and VRR ablation technology used to create
  subtle ablation shape change to subjects
  wavefront map
• Central zone steepened to provide near vision
• Peripheral zone targeted for distance vision

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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

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CustomVue Presbyopic Ablations Pre-operative
Evaluation
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CustomVue Presbyopic Ablations Pre-operative
Examination

• WaveScan System
• WaveScan exams with 6.0 mm pupils are preferred
  for treatments
• The minimum pupil size of the wavefront-measuremen
  t must be gt 5.0 mm to calculate a CustomVue
  treatment
• Measurements with a pupil size lt 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

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CustomVue Presbyopic Ablations WaveScan
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

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CustomVue Presbyopic Ablations Pre-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 gt 0.5D
• The WaveScan measurements should be stable prior
  to the treatment

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CustomVue Presbyopic Ablations Pre-operative
Examination

• Visual Acuity
• UCVA, BSCVA
• Refraction
• Manifest Refraction
• Hyperopia Pushed plus technique
• Astigmatism - Jackson Cross Cylinder - maximize
  magnitude of cylinder

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CustomVue Presbyopic Ablations Pre-operative
Examination

• When comparing Manifest Refraction to WaveScan
  Refraction use the 4 mm diameter WaveScan data
• This most closely approximates the MR

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CustomVue Presbyopic Ablations Pre-operative
Examination

• Refraction Techniques
• Cycloplegic Refraction (1 cyclopentolate)
• True cycloplegia eliminates accommodation and
  allows appropriate refractive evaluation of
• Latent hyperopia
• Critical in all Hyperopes

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CustomVue Presbyopic Ablations Pre-operative
Examination

• The anticipated post-operative keratometry value
  in any meridian must be lt 50 D
• To calculate the anticipated postoperative Ks
  add the Mean Pre-Op Keratometry to the Pre-Op
  MRSE
• Use Manual or Auto Ks
• Do not use Sim Ks

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CustomVue Presbyopic Ablations Pre-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

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CustomVue Presbyopic Ablations Pre-operative
Examination

• Slit Lamp Exam
• Tonometry
• Pachymetry
• Ultrasonic pachymetry required for LASIK
• Dilated Media and Fundus Exam

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CustomVue Presbyopic Ablations Surgical
Planning Surgical Technique
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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
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CustomVue Presbyopic Ablations Treatment Design
Screen

• Check the ENABLE box to enable a presbyopic
  correction

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CustomVue Presbyopic Ablations Environmental
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

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CustomVue Presbyopic Ablations Environmental
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 gt75º were associated with
  less accurate outcomes
• Stability of temperature and humidity is important

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CustomVue Presbyopic Ablations Iris Registration

• Iris pattern is unique to each eye
• IR aligns the preoperative WaveScan System and
  intra-operative STAR S4 IR System iris images

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CustomVue Presbyopic Ablations Iris Registration

• As the pupil changes size, its centroid may not
  remain stationary, relative to the outer iris
  boundary

LVC Treatment (photopic)
Diagnostic measurement (mesopic)
Outer Iris Boundary
For International Use Only
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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

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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

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VISX Hyperopic Presbyopia Completion of
Certification

• Acknowledgement of Understanding
• By checking the box below, I acknowledge I have
  read and understood this material