Mitomycin-c Application for PRK

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Drug: mitomycin-C; Drug: Placebo

• Registration Number: NCT01504282
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-04
• Last Update Submitted: 2012-01-04
• Study First Posted: 2012-01-05
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• The inclusion criteria was ablation depth less than 65 µm,
• a stable refractive error for at least 1 year
• corrected distance visual acuity (CDVA) of 0.1 LogMAR or better.

Exclusion Criteria

• Patients with keratoconus suspect,
• excessive dry eyes,
• impaired wound healing processes,
• lenticular changes,
• corneal dystrophy,
• history of ocular surgery,
• anterior or posterior uveitis,
• glaucoma and retinal diseases were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMC group	mitomycin-C	One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds.
BSS group	Placebo	One eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner.

Primary Outcome Measures

Name	Time	Method
Central corneal endothelial cell density (ECD) 6 months after the PRK	6 months

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of