Clinical Investigation iDesign System With 1.3-PRESBY Treatment and STAR S4 IR™ Excimer Laser System

Inclusion criteria

• ✓. Signed informed consent and Personal Health Information Protection Act authorization.
• ✓. At least 45 years of age at enrollment (date informed consent signed).
• ✓. The refractive error, based on the iDesign displayed refraction selected for treatment ("4.0 Rx calc" at 12.5 mm), must be myopia with or without astigmatism with sphere up to -6.00 D, and cylinder between 0.00 D and -5.00 D with a maximum spherical equivalent (SE) of -8.00 D.
• ✓. Require an add power of +1.00 D or more during near testing at 40 cm.
• ✓. Anticipated stromal bed thickness of at least 250 microns based on preoperative central corneal pachymetry minus the maximum ablation depth (as calculated by the iDesign system) plus the intended flap thickness.
• ✓. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.
• ✓. Uncorrected Visual Acuity (UCVA) of 20/40 or worse.
• ✓. Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.

Exclusion criteria