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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Shaheed Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00999973
First received: October 13, 2009
Last updated: October 21, 2009
Last verified: October 2009
History of Changes
  Purpose

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 Intervention Phase
Myopia
 Drug: Mitomycin C 0.02%
Drug: Placebo
 Phase 1

Study Type: Interventional
Official Title: Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia

Resource links provided by NLM:

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

Further study details as provided by Shaheed Beheshti Medical University:

Study Start Date: September 2009
Arms Assigned Interventions
Active Comparator: Mitomycin c 0.02% Drug: Mitomycin C 0.02%
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Shaheed Beheshti Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00999973     History of Changes
Other Study ID Numbers: 8804
Study First Received: October 13, 2009
Last Updated: October 21, 2009
Health Authority: Iran: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013