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NCT00999973 Clinical Trial

Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia

Myopia Clinical Trial

Official title:
Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00999973
Other study ID # 8804
Secondary ID
Status Recruiting
Phase Phase 1
First received October 13, 2009
Last updated October 21, 2009
Start date September 2009

Study information
Verified date October 2009
Source hahid Beheshti University of Medical Sciences
Contact Mohammad Ali Javadi, MD
Phone +982122585952
Email labbafi@hotmail.com
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 19 Years to 60 Years
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• Mitomycin C 0.02%

• Placebo

Locations
Country Name City State
Iran, Islamic Republic of Ophthalmic Research Center Tehran

Sponsors (1)
Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

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