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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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: 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
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

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
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
intraocular pressure
contrast sensitivity
visual function

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Brimonidine
Travoprost
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on May 23, 2013