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

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ClinicalTrials.gov Identifier: NCT00999973
Recruitment Status : Unknown
Verified October 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : October 22, 2009
Last Update Posted : October 22, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Myopia Drug: Mitomycin C 0.02% Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Official Title: Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia
Study Start Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Mitomycin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Mitomycin c 0.02% Drug: Mitomycin C 0.02%
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999973


Contacts
Contact: Mohammad Ali Javadi, MD +982122585952 labbafi@hotmail.com

Locations
Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of, 166666
Contact: Mohammad Ali Javadi, MD         
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
More Information

ClinicalTrials.gov Identifier: NCT00999973     History of Changes
Other Study ID Numbers: 8804
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: October 22, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors