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Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors
Not Recruiting
Trial ID: NCT01663363
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
Stanford Investigator(s)
Edward Manche, MD
Professor of Ophthalmology
Eligibility
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
Intervention(s):
device: LASIK correction of myopic refractive errors
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305