Visual Function Changes After Intraocular Pressure Reduction
This study has been completed.
Sponsor:
University of Sao Paulo
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
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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:
Genetics Home Reference related topics:
early-onset glaucoma
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 |
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) |
| 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
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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
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 |
| 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 Travoprost Brimonidine Tartrate 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 23, 2016