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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * 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:
  1. * 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


Edward Manche, MD
Edward Manche, MD
Professor of Ophthalmology