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Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds (BQ-01-07-ARVO)

This study has been completed.
Sponsor:
Information provided by:
Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:
NCT00564213
First received: November 26, 2007
Last updated: November 25, 2008
Last verified: November 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

Drug Information available for: Mitomycin
U.S. FDA Resources

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
Experimental: 1
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%
Experimental: 2
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

No publications provided

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

Keywords provided by Instituto de Olhos de Goiania:
Myopia
Mitomycin

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on June 13, 2013