ClinicalTrials.gov
ClinicalTrials.gov Menu

Visual Function Changes After Intraocular Pressure Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00435058
Recruitment Status : Completed
First Posted : February 14, 2007
Last Update Posted : February 19, 2007
Sponsor:
Information provided by:
University of Sao Paulo

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: timolol maleate 0,5% Drug: brimonidine tartrate 0,2% Drug: travoprost 0,004% Not Applicable

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.


Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 54 participants
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
Study Start Date : September 2005
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. intraocular pressure
  2. contrast sensitivity
  3. visual quality perception

Secondary Outcome Measures :
  1. Mean deviation of the visual field (MD)
  2. Pattern Standard Deviation of the visual field (PSD)
  3. visual acuity

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00435058     History of Changes
Other Study ID Numbers: CEP 1021/05
First Posted: February 14, 2007    Key Record Dates
Last Update Posted: February 19, 2007
Last Verified: February 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