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

Phase 1

• Conditions: Myopia
• Interventions: Drug: Mitomycin C 0.02%; Drug: Placebo

• Registration Number: NCT00999973
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Status Verified: 2009-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-21
• Last Update Submitted: 2009-10-21
• Study First Posted: 2009-10-22
• Last Update Posted: 2009-10-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mitomycin c 0.02%	Mitomycin C 0.02%	-
Placebo	Placebo	-

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of