Visual Function Changes After Intraocular Pressure Reduction

Condition(s) targeted: Glaucoma

Intervention: timolol maleate 0,5% (Drug); brimonidine tartrate 0,2% (Drug); travoprost 0,004% (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Tiago Prata, MD, Principal Investigator, Affiliation: Federal University of Sao Paulo
Luiz A Melo Jr, MD, Principal Investigator, Affiliation: Federal University of Sao Paulo

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.

Official title: Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

intraocular pressure

contrast sensitivity

visual quality perception

Secondary outcome:

Mean deviation of the visual field (MD)

Pattern Standard Deviation of the visual field (PSD)

visual acuity

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Starting date: September 2005
Ending date: April 2006
Last updated: February 16, 2007