Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors

A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser

The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.

Inclusion Criteria:

• 18 years of age or greater
• Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
• Uncorrected visual acuity (UCVA) of 20/40 or worse
• Less than 0.75D difference between cycloplegic and manifest refraction sphere.
• Demonstration of refractive stability
• Anticipated post-operative stromal bed thickness of at least 250 microns
• Willing and capable of returning for follow-up examinations for the duration of the study.

Exclusion Criteria:

• Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
• Concurrent use of topical or systemic medications that may impair healing
• History of any medical conditions that could affect wound healing
• History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
• Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
• Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course