Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors
Trial ID or NCT#
NCT01663363
Status
NOT 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 Studioâ„¢ System and Star S4IRâ„¢ Excimer Laser
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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
Investigator(s)
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