NCT01135719CompletedNot Applicable
A Prospective Randomized Comparison of Fellow Eyes Undergoing LASIK or PRK With a Wavefront-guided Excimer Laser Versus a Wavefront-optimized Excimer Laser
Edward E. Manche2 sites in 1 country137 target enrollmentStarted: April 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 137
- Locations
- 2
- Primary Endpoint
- Changes in 25 and 5% low contrast visual acuity.
Study Overview
Brief Summary
Subjects with myopia, hyperopia and astigmatism are being randomized to be treated in one eye with a wavefront-guided excimer laser and their fellow eye treated with a wavefront-optimized excimer laser.
Detailed Description
Subjects with myopia, hyperopia and astigmatism are being randomized by ocular dominance to be treated with either PRK or LASIK. One eye will be treated with a wavefront-guided excimer laser and the fellow eye will be treated with a wavefront optimized excimer laser.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy subjects age 21 and older.
- •Subjects with nearsightedness, farsightedness and/or astigmatism.
Exclusion Criteria
- •Autoimmune diseases.
- •Children.
- •Women pregnant or nursing.
- •Ectatic corneal disease.
- •Previous ocular surgery.
Outcomes
Primary Outcomes
Changes in 25 and 5% low contrast visual acuity.
Time Frame: One year
Improvement in uncorrected visual acuity
Time Frame: One year
Changes in best spectacle corrected visual acuity.
Time Frame: One year
Secondary Outcomes
- Changes in higher order aberrations.(One year)
- Topographic changes.(One year)
- Quality of vision changes.(One year)
Investigators
Edward E. Manche
Stanford University School of Medicine
Stanford University
Study Sites (2)
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