Back to resultsStudy on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia
Primary Purpose
Myopia
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Mitomycin C 0.02%
Placebo
Sponsored by
About this trial
This is an interventional trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 19 < age < 60
- Refractory error stabled for at least one year
- No corneal pathology
- -3 < bilateral myopia and astigmatism < -5 with no difference more than 0.75 between 2 eyes
Exclusion criteria:
- Keratoconus
- Ectatic corneal disease
- Glaucoma
- Corneal dystrophy
- Lens changes affecting the visual acuity
- Anterior or posterior uveitis
- Corneal scar
Sites / Locations
- Ophthalmic Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mitomycin c 0.02%
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00999973
First Posted
October 13, 2009
Last Updated
October 21, 2009
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00999973
Brief Title
Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia
Official Title
Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study 126 eyes in 63 patients with moderate bilateral myopia and astigmatism between -3 and -5 (SE difference between two eyes should not be more than 0.75 and the residual corneal thickness>350 μ ) were entered in the study. One eye went randomly under PRK with mitomycin C 0.02% in 15 min and then the other eye went under the operation without MMC. UCVA,BCVA, refractory error after the operation and the number of endothelial cells before and after the surgery would be compared in 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Study Phase
Phase 1
8. Arms, Groups, and Interventions
Arm Title
Mitomycin c 0.02%
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mitomycin C 0.02%
Intervention Type
Drug
Intervention Name(s)
Placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Eligibility Criteria
Inclusion Criteria:
19 < age < 60
Refractory error stabled for at least one year
No corneal pathology
-3 < bilateral myopia and astigmatism < -5 with no difference more than 0.75 between 2 eyes
Exclusion criteria:
Keratoconus
Ectatic corneal disease
Glaucoma
Corneal dystrophy
Lens changes affecting the visual acuity
Anterior or posterior uveitis
Corneal scar
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Ali Javadi, MD
Phone
+982122585952
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
ZIP/Postal Code
166666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Ali Javadi, MD
12. IPD Sharing Statement
Learn more about this trial
Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia
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