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

Trial ID or NCT#

NCT01663363

Status

not recruiting iconNOT RECRUITING

Purpose

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

Investigator(s)

Edward Manche, MD
Edward Manche, MD
Ophthalmologist
Professor of Ophthalmology