Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)
Phase 2
Completed
- Conditions
- MyopiaRefractive Error
- Interventions
- Procedure: Alcohol-assisted debridementProcedure: Mechanical debridement
- Registration Number
- NCT00918697
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alcohol-asstisted debridement Alcohol-assisted debridement In this arm, corneal epithelium was removed using ethanol 20% during PRK. Mechanical debridment Mechanical debridement In this arm, corneal epithelium was removed during PRK using conventional mechanical method.
- Primary Outcome Measures
Name Time Method Corneal cellular elements. Confocal microscopic findings of corneal cellular elements.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ophthalmic Research Center
🇮🇷Tehran, Iran, Islamic Republic of