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NCT05548478 Clinical Trial

Corneal Endothelial Cell Injury Induced by Mitomycin-C

Myopia Clinical Trial

Official title:
Corneal Endothelial Cell Injury Induced by Mitomycin-C in TransEpi Single Step and Alcohol Assisted Photorefractive Keratectomy PRK: A Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05548478
Other study ID # Mitomycin-C
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2022
Est. completion date February 2023

Study information
Verified date September 2022
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

our study will investigate the effecacy of Mitomycin-C in TransEpi single step photorefractive keratectomy (PRK) and alcohol assisted PRK

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date February 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 17 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Transepithelial PRK/MMC
transepithelial photorefractive keratectomy (PRK) and mitomycin C addition
• Alcohol-Assisted PRK/MMC
photorefractive keratectomy (PRK) assisted by alchol and mitomycin C addition

Locations
Country Name City State
Egypt Ehab tharwat Damieta New Damietta

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endothelial cell Density will be measured by Specular microscopy Base line
Primary Endothelial cell Density will be measured by Specular microscopy at 1st month
Primary Endothelial cell Density will be measured by Specular microscopy at 3rd month
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