Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia

Inclusion Criteria

• •1. Signed informed consent and HIPAA authorization.
• •2. At least 40 years of age at enrollment (date informed consent signed).
• •3. The refractive error of both subject's eyes, based on the iDesign refraction selected for treatment ("4.0 mm Rx calc" at 12.5 mm), must be myopic with or without astigmatism up to -6.00 D spherical equivalent (SE), with cylinder up to -3.00 D and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopic retention.
• •4. At least one eye must require a myopic treatment.
• •5. Anticipated stromal bed thickness of at least 250 microns based on preoperative central corneal pachymetry minus the maximum treatment depth to be ablated (as calculated by the iDesign plus the intended flap thickness).
• •6. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.
• •7. Require an add power of +1.25 D or more but not greater than +2.00 D at 40 cm.
• •8. Less than or equal to ±0.50 D difference between cycloplegic and manifest refraction sphere.
• •9. A stable refractive error (based on a previous exam, medical records, lensometry, or prescription that is at least 12 months prior to the preoperative manifest refraction), as defined by a change of less than or equal to
• •* 0.50 D in MRSE (sphere and cylinder).
• •10. Subjects with a history of contact lens wear within the last 4 weeks must discontinue lens wear in order to demonstrate refractive stability according to the following (refractive stability is defined as a change of not more than 0.50 D in manifest refraction sphere and cylinder as well as mean keratometry between measurements): After the Informed Consent process has been completed and subjects are enrolled in the study:
• •* Rigid or extended wear contact lenses (toric or spherical) must be removed for at least 3 weeks and soft contact lenses (toric or spherical) for at least 2 weeks prior to the first refraction used to establish stability.
• •* After abstaining from contact lens wear for designated time, two consecutive manifest refractions and keratometric readings must be conducted at least 7 days apart
• •* I If the subject/eye meets the refractive stability criteria, contact lens wear is not permitted for 2 weeks prior to surgery except as required to test monovision acceptance as described below in the Study Procedures, Contact Lens Trial section NOTE: Refractive stability needs to be confirmed only once during preoperative assessment
• •11. Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment, as follows:
• •* Spherical Equivalent: magnitude of the difference is less than 0.625 D.
• •* Cylinder: magnitude of the difference is less than or equal to 0.5 D.
• •* Cylinder Axis Tolerance: If either the manifest cylinder entered into the iDesign System or the iDesign cylinder selected for treatment is less than 0.5 D, there is no requirement for axis agreement. When both cylinders have a magnitude of at least 0.5 D, the axis tolerance as determined by the iDesign system is linearly reduced from 15 degrees (0.5 D) to 7.5 degrees (7.0 D) based on the average magnitude of both cylinders. Note: If the axis tolerance is not in the calculated range, the iDesign system will produce a warning and this exam may not be used for treatment planning.
• •12. Willing and capable of complying with follow-up examinations for the duration of the study.