During the glaucomatous disease process, subpopulations of cells may be dead, damaged or healthy. Visual function changes could be observed due to a recovering of the suffering ganglion cells after the intraocular pressure reduction. This study aims at evaluating the correlation between intraocular pressure reduction and visual function changes in glaucoma patients after using antiglaucoma...
Date First Received: February 12, 2007
Last Updated: February 16, 2007
Verified by: University of Sao Paulo, February 2007
Clinical Trial Phase: N/A | Start Date: September 2005
Overall Status: Completed
Estimated Enrollment: 54
Brief Summary
Official Title: “Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial”
Condition Keyword(s):
During the glaucomatous disease process, subpopulations of cells may be dead, damaged or healthy. Visual function changes could be observed due to a recovering of the suffering ganglion cells after the intraocular pressure reduction. This study aims at evaluating the correlation between intraocular pressure reduction and visual function changes in glaucoma patients after using antiglaucoma medications.
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Detailed Clinical Trial Description
Primary open angle glaucoma patients without use of antiglaucoma medications will be enrolled in this study. After inclusion, the patients will randomly receive one of three antiglaucoma medications (timolol maleate 0,5%, brimonidine tartrate 0,2% or travoprost 0,004%) in one randomly selected eye.
The patients will be evaluated with Goldmann applanation tonometry, visual acuity test, contrast sensitivity test, visual quality perception test (visual analogue scale) and standard automated perimetry before and after 4 weeks of glaucoma treatment onset.
Intervention(s) in this Clinical Trial
- Drug: timolol maleate 0,5%
- Drug: brimonidine tartrate 0,2%
- Drug: travoprost 0,004%
Outcome Measures for this Clinical Trial
Primary Measures
- intraocular pressure
- contrast sensitivity
- visual quality perception
Secondary Measures
- Mean deviation of the visual field (MD)
- Pattern Standard Deviation of the visual field (PSD)
- visual acuity
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Primary open angle glaucoma
- Intraocular pressure greater than 21 mmHg
Exclusion Criteria:
- Best corrected visual acuity (BCVA) worse than 20/80
- Significant media opacity
- History of steroid use
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Sao Paulo
Overall Clinical Trial Officials and Contacts
Tiago Prata, MD Principal Investigator Federal University of Sao Paulo
Additional Information
Information obtained from ClinicalTrials.gov on March 10, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00435058
Study ID Number: CEP 1021/05
ClinicalTrials.gov Identifier: NCT00435058
Health Authority: Brazil: National Committee of Ethics in Research
Clinical Trials Authorship and Review
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