Visual Function Changes After Intraocular Pressure Reduction

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435058
• Other study ID #: CEP 1021/05
• Status: Completed
• Phase: N/A
• First received: February 12, 2007
• Last updated: February 16, 2007
• Start date: September 2005
• Est. completion date: April 2006

Study information

• Verified date: February 2007
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• timolol maleate 0,5%

• brimonidine tartrate 0,2%

• travoprost 0,004%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure
Primary	contrast sensitivity
Primary	visual quality perception
Secondary	Mean deviation of the visual field (MD)
Secondary	Pattern Standard Deviation of the visual field (PSD)
Secondary	visual acuity