Visual Function Changes After Intraocular Pressure Reduction - Full Text View

Sponsored by:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00435058

Purpose

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.

Condition	Intervention
Glaucoma	Drug: timolol maleate 0,5% Drug: brimonidine tartrate 0,2% Drug: travoprost 0,004%

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Timolol maleate Brimonidine Brimonidine tartrate Travoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

intraocular pressure
contrast sensitivity
visual quality perception

Secondary Outcome Measures:

Mean deviation of the visual field (MD)
Pattern Standard Deviation of the visual field (PSD)
visual acuity

Estimated Enrollment:	54
Study Start Date:	September 2005
Estimated Study Completion Date:	April 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435058

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:	Tiago Prata, MD	Federal University of Sao Paulo
Principal Investigator:	Luiz A Melo Jr, MD	Federal University of Sao Paulo

More Information

No publications provided

Study ID Numbers:	CEP 1021/05
Study First Received:	February 12, 2007
Last Updated:	February 16, 2007
ClinicalTrials.gov Identifier:	NCT00435058 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:

intraocular pressure
contrast sensitivity
visual function

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Eye Diseases
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Travoprost

Glaucoma
Adrenergic beta-Antagonists
Adrenergic Antagonists
Timolol
Anti-Arrhythmia Agents
Ocular Hypertension
Hypertension
Brimonidine

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists

Pharmacologic Actions
Glaucoma
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Timolol
Anti-Arrhythmia Agents
Ocular Hypertension
Brimonidine

ClinicalTrials.gov processed this record on May 07, 2009