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Sponsors and Collaborators: |
Asociación para Evitar la Ceguera en México None |
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Information provided by: | Asociación para Evitar la Ceguera en México |
ClinicalTrials.gov Identifier: | NCT00599950 |
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).
Condition | Intervention | Phase |
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Refractive Disorders |
Drug: Mitomycin C and Photorefractive keratectomy (PRK) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C. |
Enrollment: | 10 |
Study Start Date: | January 2007 |
Study Completion Date: | November 2007 |
Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
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Drug: Mitomycin C and Photorefractive keratectomy (PRK)
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
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2: Placebo Comparator
Photorefractive keratectomy (PRK)without mitomycin C.
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Drug: Mitomycin C and Photorefractive keratectomy (PRK)
Topical mitomycin C on the corneal epithelium of patients undergoing photorefractive keratectomy (PRK)
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Mexico, Distrito Federal | |
Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes". | |
Mexico city, Distrito Federal, Mexico, 04030 |
Principal Investigator: | Ramirez F Manuel, MD | APEC |
Responsible Party: | Asociación para Evitar la Ceguera en México ( Asociación para Evitar la Ceguera en México ) |
Study ID Numbers: | Cornea 4, No |
Study First Received: | January 8, 2008 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00599950 |
Health Authority: | Mexico: Ethics Committee |
Mitomycin C Corneal epithelium Photorefractive keratectomy (PRK) Confocal microscope |
Eye Diseases Mitomycin Mitomycins Refractive Errors |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
Antibiotics, Antineoplastic Alkylating Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |