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

High Myopia Clinical Trial

— BQ-01-07-ARVO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564213
• Other study ID #: BQ -1-07-ARVO
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2007
• Last updated: November 25, 2008
• Start date: March 2005
• Est. completion date: September 2007

Study information

• Verified date: November 2007
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Myopia or compound myopic astigmatism

• Stable refractive error

• No associated eye disease

Exclusion Criteria:

• Diabetes,

• Autoimmune diseases

• Topographic abnormalities

Study Design

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

Related Conditions & MeSH terms

• High Myopia
• Myopia

Intervention

Drug:
• PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
Mitomycin 0.02%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania