GlaucomaNCT00435058
Visual Function Changes After Intraocular Pressure Reduction
A study testing timolol maleate 0,5%, brimonidine tartrate 0,2% and travoprost 0,004% in people with Glaucoma, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- timolol maleate 0,5%, brimonidine tartrate 0,2% and travoprost 0,004%
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary open angle glaucoma
- Intraocular pressure greater than 21 mmHg
Who cannot join
- Best corrected visual acuity (BCVA) worse than 20/80
- Significant media opacity
- History of steroid use
About this study
Official title: Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- timolol maleate 0,5%, brimonidine tartrate 0,2%, travoprost 0,004%
- Keywords
- intraocular pressure, contrast sensitivity, visual function
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
timolol maleate 0,5%Drug
brimonidine tartrate 0,2%Drug
travoprost 0,004%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
contrast sensitivity
visual quality perception
Secondary outcomes (3)
Mean deviation of the visual field (MD)
Pattern Standard Deviation of the visual field (PSD)
visual acuity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2007 (estimated)
- Study startSep 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 54 participants
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Tiago Prata, MD, Principal investigator, Federal University of São PauloLuiz A Melo Jr, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435058
- Sponsor's protocol ID
- CEP 1021/05
- Status last verified
- Feb 2007
- First submitted
- 12 Feb 2007
- Last updated
- 19 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00435058
- Acronym / sponsor ID
- CEP 1021/05
- Conditions
- Glaucoma
- Keywords
- intraocular pressure, contrast sensitivity, visual function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Apr 2006
- First posted
- 14 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary open angle glaucoma
- Intraocular pressure greater than 21 mmHg
Key exclusion criteria (3 listed)
- Best corrected visual acuity (BCVA) worse than 20/80
- Significant media opacity
- History of steroid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| timolol maleate 0,5% | Drug | – |
| brimonidine tartrate 0,2% | Drug | – |
| travoprost 0,004% | Drug | – |
Primary outcome
intraocular pressure
contrast sensitivity
visual quality perception
3 secondary outcomes
Mean deviation of the visual field (MD)
Pattern Standard Deviation of the visual field (PSD)
visual acuity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiago Prata, MD principal investigator
Federal University of São Paulo
Luiz A Melo Jr, MD principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing timolol maleate 0,5%, brimonidine tartrate 0,2% and travoprost 0,004% in people with Glaucoma, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2007; AzTrials last refreshed its copy on 29 Oct 2026.