Mitomycin-c Application for PRK

This study has been completed.
Information provided by:
Shahid Beheshti University of Medical Sciences Identifier:
First received: January 4, 2012
Last updated: NA
Last verified: June 2010
History: No changes posted
To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.

Condition Intervention
Drug: mitomycin-C
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mitomycin-c Application for Photorefractive Keratectomy

Resource links provided by NLM:

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Central corneal endothelial cell density (ECD) 6 months after the PRK [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Arms Assigned Interventions
Active Comparator: MMC group
One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds.
Drug: mitomycin-C
Placebo Comparator: BSS group
One eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner.
Drug: Placebo
balanced salt solution (BSS)


Genders Eligible for Study:   Both

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.
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Please refer to this study by its identifier: NCT01504282

Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
  More Information Identifier: NCT01504282     History of Changes
Other Study ID Numbers: 8901 
Study First Received: January 4, 2012
Last Updated: January 4, 2012
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors processed this record on May 26, 2016