Visual Function Changes After Intraocular Pressure Reduction

This study has been completed.

Sponsor:

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT00435058

First received: February 12, 2007

Last updated: February 16, 2007

Last verified: February 2007

History of Changes

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%


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Treatment
Official Title:	Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

U.S. FDA Resources

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00435058 History of Changes
Other Study ID Numbers:	CEP 1021/05
Study First Received:	February 12, 2007
Last Updated:	February 16, 2007

Keywords provided by University of Sao Paulo:


intraocular pressure contrast sensitivity visual function

Additional relevant MeSH terms:


Timolol Brimonidine Tartrate Travoprost Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents	Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists

ClinicalTrials.gov processed this record on September 21, 2017

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