Mitomycin-c Application for PRK

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

January 4, 2012
January 4, 2012
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Central corneal endothelial cell density (ECD) 6 months after the PRK [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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Mitomycin-c Application for PRK
Mitomycin-c Application for Photorefractive Keratectomy

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

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Myopia
  • Drug: mitomycin-C
  • Drug: Placebo
    balanced salt solution (BSS)
  • Active Comparator: MMC group
    One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds.
    Intervention: 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.
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
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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.
Both
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Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01504282
8901
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Shahid Beheshti Medical University
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Shahid Beheshti Medical University
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP