NCT00918697CompletedPhase 2
Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial
Shahid Beheshti University of Medical Sciences2 sites in 1 country33 target enrollmentStarted: July 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Corneal cellular elements.
Study Overview
Brief Summary
In this prospective randomized clinical trial, confocal microscopy was used to evaluate the effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive keratectomy (PRK)on corneal cellular elements. Sixty-six eyes of 33 subjects with a spherical equivalent less than -4.00 D who completed all follow-up visits were evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •spherical equivalent ≤ -4.0 D
- •cylinder ≤ 1.50 D
Exclusion Criteria
- •history of ocular trauma or surgery
- •any corneal and ocular pathologies
- •central corneal thickness < 500 µm
- •scotopic pupil diameter > 6.0 mm
- •any abnormalities in corneal plain or elevation topographies favoring keratoconus or other ectatic disorders
- •the presence of systemic disorders such as collagen vascular diseases
Outcomes
Primary Outcomes
Corneal cellular elements.
Confocal microscopic findings of corneal cellular elements.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
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