Mitomycin-c Application for PRK

This study has been completed.

Sponsor:

Information provided by:

Shaheed Beheshti Medical University

ClinicalTrials.gov Identifier:

NCT01504282

First received: January 4, 2012

Last updated: NA

Last verified: June 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	January 4, 2012
Last Updated Date	January 4, 2012
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: January 4, 2012)	Central corneal endothelial cell density (ECD) 6 months after the PRK [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Mitomycin-c Application for PRK
Official Title ^ICMJE	Mitomycin-c Application for Photorefractive Keratectomy
Brief Summary	To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Myopia
Intervention ^ICMJE	Drug: mitomycin-C Drug: Placebo balanced salt solution (BSS)
Study Arm (s)	Active Comparator: MMC group One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds. Intervention: Drug: mitomycin-C Placebo Comparator: BSS group One eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner. Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	90
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Iran, Islamic Republic of

Administrative Information
NCT Number ^ICMJE	NCT01504282
Other Study ID Numbers ^ICMJE	8901
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Shaheed Beheshti Medical University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Shaheed Beheshti Medical University
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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