Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

This study has been completed.

Sponsor:

Information provided by:

Asociación para Evitar la Ceguera en México

ClinicalTrials.gov Identifier:

NCT00599950

First received: January 8, 2008

Last updated: January 23, 2008

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

January 8, 2008

Last Updated Date

January 23, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

A central scan of the anterior stroma was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) [ Time Frame: Before surgery and 1 week, 1 month, 3 months, 6 months after surgery ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00599950 on ClinicalTrials.gov Archive Site

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

Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C

Official Title ^ICMJE

Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C.

Brief Summary

To evaluate the confocal microscopy changes in keratocyte density at the anterior stromal after Photorefractive keratectomy (PRK) surgery, using intraoperative mitomycin C(Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA).

Detailed Description

10 eyes of 10 patients underwent PRK,using intraoperative mitomycin C (Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA), and 10 eyes for the same patients underwent PRK without intraoperative mitomycin C. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) after surgery, and 1 week, 1 month, 3 months, and 6 months after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Refractive Disorders

Intervention ^ICMJE

Drug: Mitomycin C and Photorefractive keratectomy (PRK)

Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)

Study Arm (s)

Experimental: 1
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)

Intervention: Drug: Mitomycin C and Photorefractive keratectomy (PRK)
Placebo Comparator: 2
Photorefractive keratectomy (PRK)without mitomycin C.

Intervention: Drug: Mitomycin C and Photorefractive keratectomy (PRK)

Publications *

* 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

Completion Date

November 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients ask for PRK surgery
Patients with stable refraction in the last year
Patients without systemic and ocular disease
Patients with 500 microns in pachymetry normal topography

Exclusion Criteria:

Patients cannot attend their appointments
Residual, recurrent or active ocular disease
Previous ocular surgery except PRK
Autoimmune or connective tissue disease
Pregnancy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Mexico

Administrative Information

NCT Number ^ICMJE

NCT00599950

Other Study ID Numbers ^ICMJE

Cornea 4

Has Data Monitoring Committee

Yes

Responsible Party

Asociación para Evitar la Ceguera en México

Study Sponsor ^ICMJE

Asociación para Evitar la Ceguera en México

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ramirez F Manuel, MD

APEC

Information Provided By

Asociación para Evitar la Ceguera en México

Verification Date

November 2007

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

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