NCT05548478RecruitingNot Applicable
Corneal Endothelial Cell Injury Induced by Mitomycin-C in TransEpi Single Step and Alcohol Assisted Photorefractive Keratectomy PRK: A Comparative Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Al-Azhar University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Endothelial cell Density
Study Overview
Brief Summary
our study will investigate the effecacy of Mitomycin-C in TransEpi single step photorefractive keratectomy (PRK) and alcohol assisted PRK
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age over 18 years.
- •Primary myopia or compound myopic astigmatism.
- •Preoperative manifest refraction spherical equivalent (MRSE) within the range of -1.0 to 8 D
- •Stable refractive error for at least 12 months before the surgery.
- •Contact lens discontinuation for at least 3 weeks.
- •Estimated corneal stromal bed thickness of more than 300mm at the thinnest point
Exclusion Criteria
- •Unwilling to participate in the study.
- •Previous ocular surgery
- •Any diagnosed ocular disease
- •History of ocular trauma
Arms & Interventions
TransEpi single step PRK
Active Comparator
Intervention: Transepithelial PRK/MMC (Procedure)
alcohol assisted PRK
Active Comparator
Intervention: Alcohol-Assisted PRK/MMC (Procedure)
Outcomes
Primary Outcomes
Endothelial cell Density
Time Frame: at 3rd month
will be measured by Specular microscopy
Endothelial cell Density
Time Frame: Base line
will be measured by Specular microscopy
Endothelial cell Density
Time Frame: at 1st month
will be measured by Specular microscopy
Secondary Outcomes
No secondary outcomes reported
Investigators
Ehab tharwat
Dr
Al-Azhar University
Study Sites (1)
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