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NCT01504282 Clinical Trial

Mitomycin-c Application for PRK

Myopia Clinical Trial

Official title:
Mitomycin-c Application for Photorefractive Keratectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01504282
Other study ID # 8901
Secondary ID
Status Completed
Phase N/A
First received January 4, 2012
Last updated January 4, 2012

Study information
Verified date June 2010
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- The inclusion criteria was ablation depth less than 65 µm,

- a stable refractive error for at least 1 year

- corrected distance visual acuity (CDVA) of 0.1 LogMAR or better.

Exclusion Criteria:

- Patients with keratoconus suspect,

- excessive dry eyes,

- impaired wound healing processes,

- lenticular changes,

- corneal dystrophy,

- history of ocular surgery,

- anterior or posterior uveitis,

- glaucoma and retinal diseases were excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• mitomycin-C

• Placebo
balanced salt solution (BSS)

Locations
Country Name City State
Iran, Islamic Republic of Ophthalmic Research Center Tehran

Sponsors (1)
Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Central corneal endothelial cell density (ECD) 6 months after the PRK 6 months Yes
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