Visual Function Changes After Intraocular Pressure Reduction

NCT ID: NCT00435058

Last Updated: 2007-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-04-30

Brief Summary

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.

Detailed 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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

timolol maleate 0,5%

Intervention Type: DRUG

brimonidine tartrate 0,2%

Intervention Type: DRUG

travoprost 0,004%

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Principal Investigators

Tiago Prata, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Luiz A Melo Jr, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Other Identifiers

CEP 1021/05

Identifier Type: -

Identifier Source: org_study_id