NCT00999973

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
Last Updated

October 22, 2009

Status Verified

October 1, 2009

First QC Date

October 13, 2009

Last Update Submit

October 21, 2009

Conditions

Myopia

Study Arms (2)

Mitomycin c 0.02%

ACTIVE COMPARATOR
Drug: Mitomycin C 0.02%

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Mitomycin C 0.02%DRUG
Mitomycin c 0.02%
PlaceboDRUG
Placebo

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • \< age \< 60
  • Refractory error stabled for at least one year
  • No corneal pathology
  • \< bilateral myopia and astigmatism \< -5 with no difference more than 0.75 between 2 eyes

You may not qualify if:

  • Keratoconus
  • Ectatic corneal disease
  • Glaucoma
  • Corneal dystrophy
  • Lens changes affecting the visual acuity
  • Anterior or posterior uveitis
  • Corneal scar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, 166666, Iran

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Mohammad Ali Javadi, MD

CONTACT

+982122585952labbafi@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 22, 2009

Study Start

September 1, 2009

Last Updated

October 22, 2009

Record last verified: 2009-10

Locations

IR(1)