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Mitomycin-c Application for PRK

This study has been completed.
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01504282
First received: January 4, 2012
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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


Condition Intervention
Myopia
 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:

Drug Information available for: Mitomycin
U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

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)

  Eligibility

Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504282

Locations
Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shaheed Beheshti Medical University
  More Information

No publications provided

ClinicalTrials.gov 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:
Myopia
Refractive Errors
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on May 16, 2013