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

Not Recruiting

Trial ID: NCT01663363


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

Official Title

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

Stanford Investigator(s)

Edward Manche, MD
Edward Manche, MD

Professor of Ophthalmology


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

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

   - Known sensitivity or inappropriate responsiveness to any of the medications used in
   the post-operative course


device: LASIK correction of myopic refractive errors

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305