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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
  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:


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
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

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:
Brimonidine
Timolol
Adrenergic Agents
Adrenergic Agonists
Adrenergic Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014