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

November 26, 2007
November 25, 2008
March 2005
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Complete list of historical versions of study NCT00564213 on ClinicalTrials.gov Archive Site
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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
Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds

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

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
High Myopia
Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
Mitomycin 0.02%
  • Experimental: 1
    A single intraoperative topical application of mitomycin C 0.02% for 15 seconds
    Intervention: Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
  • Experimental: 2
    A single intraoperative topical application of mitomycin C 0.02% for 30 seconds
    Intervention: Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
September 2007
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Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes,
  • Autoimmune diseases
  • Topographic abnormalities
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00564213
BQ -1-07-ARVO
Yes
Not Provided
Instituto de Olhos de Goiania
Not Provided
Study Chair: Belquiz A Nassaralla Instituto de Olhos de GOiânia
Instituto de Olhos de Goiania
November 2007

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