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Mitomycin-c Application for PRK

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ClinicalTrials.gov Identifier: NCT01504282
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : January 5, 2012
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Myopia Drug: mitomycin-C Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mitomycin-c Application for Photorefractive Keratectomy

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Central corneal endothelial cell density (ECD) 6 months after the PRK [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504282


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

ClinicalTrials.gov Identifier: NCT01504282     History of Changes
Other Study ID Numbers: 8901
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: June 2010

Additional relevant MeSH terms:
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors