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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Myopia

Study Groups

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Mitomycin c 0.02%

Group Type ACTIVE_COMPARATOR

Mitomycin C 0.02%

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Mitomycin C 0.02%

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No