Back to resultsMitomycin-c Application for PRK
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
mitomycin-C
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Myopia
Eligibility 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.
Sites / Locations
- Ophthalmic Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MMC group
BSS group
Arm Description
One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds.
One eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner.
Outcomes
Primary Outcome Measures
Central corneal endothelial cell density (ECD) 6 months after the PRK
Secondary Outcome Measures
Full Information
NCT ID
NCT01504282
First Posted
January 4, 2012
Last Updated
January 4, 2012
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01504282
Brief Title
Mitomycin-c Application for PRK
Official Title
Mitomycin-c Application for Photorefractive Keratectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Arm Title
MMC group
Arm Type
Active Comparator
Arm Description
One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds.
Arm Title
BSS group
Arm Type
Placebo Comparator
Arm Description
One eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner.
Intervention Type
Drug
Intervention Name(s)
mitomycin-C
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
balanced salt solution (BSS)
Primary Outcome Measure Information:
Title
Central corneal endothelial cell density (ECD) 6 months after the PRK
Time Frame
6 months
10. Eligibility
Sex
All
Eligibility 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.
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Mitomycin-c Application for PRK
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