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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:
ClinicalTrials.gov Identifier:
NCT00564213
First Posted: November 27, 2007
Last Update Posted: November 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Instituto de Olhos de Goiania
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564213


Sponsors and Collaborators
Instituto de Olhos de Goiania
Investigators
Study Chair: Belquiz A Nassaralla Instituto de Olhos de GOiânia
  More Information

ClinicalTrials.gov Identifier: NCT00564213     History of Changes
Other Study ID Numbers: BQ -1-07-ARVO
First Submitted: November 26, 2007
First Posted: November 27, 2007
Last Update Posted: November 26, 2008
Last Verified: November 2007

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
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors