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

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 1

Conditions: Myopia

Treatments: Drug: Mitomycin C 0.02%; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00999973

8804

Details and patient eligibility

About

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.

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups, including a placebo group

Mitomycin c 0.02%

Active Comparator group

Treatment:

Drug: Mitomycin C 0.02%

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo