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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:
Shahid Beheshti University of Medical Sciences

October 13, 2009
October 22, 2009
October 22, 2009
September 2009
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No Changes Posted
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Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia
Study on the Effect of Mitomycin C 0.02% on the Corneal Endothelial After Photorefractive Keratectomy in Moderate Myopia
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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Interventional
Phase 1
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Myopia
  • Drug: Mitomycin C 0.02%
  • Drug: Placebo
  • Active Comparator: Mitomycin c 0.02%
    Intervention: Drug: Mitomycin C 0.02%
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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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
Sexes Eligible for Study: All
19 Years to 60 Years   (Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT00999973
8804
Yes
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Shahid Beheshti University of Medical Sciences
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Shahid Beheshti University of Medical Sciences
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP