Mitomycin-c Application for PRK

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Myopia

Treatments: Drug: mitomycin-C; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01504282

8901

Details and patient eligibility

About

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

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

MMC group

Active Comparator group

Description:

One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds.

Treatment:

Drug: mitomycin-C

BSS group

Placebo Comparator group

Description:

One eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner.

Treatment:

Drug: Placebo