Corneal Endothelial Cell Injury Induced by Mitomycin-C

Al-Azhar University

Status: Enrolling

Conditions: Myopia

Treatments: Procedure: Alcohol-Assisted PRK/MMC; Procedure: Transepithelial PRK/MMC

Study type: Interventional

Funder types: Other

Identifiers

NCT05548478

Mitomycin-C

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 17 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

TransEpi single step PRK

Active Comparator group

Treatment:

Procedure: Transepithelial PRK/MMC

alcohol assisted PRK

Active Comparator group

Treatment:

Procedure: Alcohol-Assisted PRK/MMC