Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds - Full Text View

Sponsored by:	Instituto de Olhos de Goiania
Information provided by:	Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:	NCT00564213

Purpose

To evaluate and compare the effect of the prophylactic use of two different exposure times of mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for high myopia (> -7.0 D).

Methods: Forty six eyes of twenty three patients, 8 men and 15 women, with high myopia were included in this prospective study. Mean age at the time of PRK plus MMC was 31.7 years. Before PRK, the mean spherical equivalent was -8.50 D (range, -7.25 to -10.50 D). In each patient, one eye was randomly assigned to PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Group 1) and the fellow eye, for 30 seconds (Group 2).The inclusion criteria were high myopia, no central corneal opacity and inadequate corneal thickness to allow a safe Laser in situ keratomileusis procedure. Refraction, uncorrected visual acuity, best spectacle-corrected visual acuity (BSCVA), and slit-lamp evidence of corneal opacity (haze) were evaluated over 12 months

Condition	Intervention	Phase
High Myopia	Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds	Phase IV

Drug Information available for: Mitomycin Mitomycins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds

Further study details as provided by Instituto de Olhos de Goiania:

Estimated Enrollment:	36
Study Start Date:	March 2005
Study Completion Date:	September 2007

Arms	Assigned Interventions
1: Experimental A single intraoperative topical application of mitomycin C 0.02% for 15 seconds	Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds Mitomycin 0.02%
2: Experimental A single intraoperative topical application of mitomycin C 0.02% for 30 seconds	Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds Mitomycin 0.02%

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Myopia or compound myopic astigmatism
Stable refractive error
No associated eye disease

Exclusion Criteria:

Diabetes,
Autoimmune diseases
Topographic abnormalities

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564213

Sponsors and Collaborators

Instituto de Olhos de Goiania

Investigators

Study Chair:

Belquiz A Nassaralla

Instituto de Olhos de GOiânia

More Information

Study ID Numbers:	BQ -1-07-ARVO
Study First Received:	November 26, 2007
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00564213
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Instituto de Olhos de Goiania:

Myopia
Mitomycin

Study placed in the following topic categories:

Eye Diseases
Mitomycin
Corneal Opacity
Myopia

Mitomycins
Refractive Errors
Myopia, severe

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009