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

NCT00564213 | Completed Phase 4 DMC

• 1 other identifier: BQ -1-07-ARVO
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

High Myopia

Keywords

Myopia; Mitomycin

Study Arms (2)

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

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

Interventions

PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds DRUG

Mitomycin 0.02%

1; 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diabetes,
• Autoimmune diseases
• Topographic abnormalities

Sponsors & Collaborators

• Instituto de Olhos de Goiania: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Belquiz A Nassaralla

  Instituto de Olhos de GOiânia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 27, 2007
• Study Start: March 1, 2005
• Study Completion: September 1, 2007
• Last Updated: November 26, 2008

Record last verified: 2007-11