CClinicalTrials.gg
Status unknownNCT00999973Updated Oct 22, 2009

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

A Phase 1 interventional study of Mitomycin C 0.02% and Placebo in Myopia, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2009-10-22.

Sponsored by Shahid Beheshti University of Medical Sciences · Phase 1 and Interventional

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Ages
19 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myopia

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

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Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All

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

Exclusion criteria:

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

Phase
Phase 1

Study arms

  • Active comparator
    Mitomycin c 0.02%

    Drug: Mitomycin C 0.02%

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugMitomycin C 0.02%
  • DrugPlacebo
06

Study locations

1 of 1 sites recruiting
  • Ophthalmic Research Center
    Tehran, 166666, Iran, Islamic Republic of
    • Mohammad Ali Javadi, MD · Contact
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00999973
Lead sponsor
Shahid Beheshti University of Medical Sciences
First posted
Oct 22, 2009
Start date
Sep 2009
Last update
Oct 22, 2009

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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