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CompletedNCT00435058Updated Feb 19, 2007

Visual Function Changes After Intraocular Pressure Reduction

An interventional study of timolol maleate 0,5% and brimonidine tartrate 0,2% in Glaucoma, sponsored by University of Sao Paulo. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2007-02-19.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Glaucoma

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Keywords

  • intraocular pressure
  • contrast sensitivity
  • visual function
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 54 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Primary open angle glaucoma
  • Intraocular pressure greater than 21 mmHg

Exclusion criteria

Exclusion Criteria:

  • Best corrected visual acuity (BCVA) worse than 20/80
  • Significant media opacity
  • History of steroid use
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
54 participants

Interventions

  • Drugtimolol maleate 0,5%
  • Drugbrimonidine tartrate 0,2%
  • Drugtravoprost 0,004%
06

What researchers measure

Primary outcomes

  1. intraocular pressure

  2. contrast sensitivity

  3. visual quality perception

Secondary outcomes

  1. Mean deviation of the visual field (MD)

  2. Pattern Standard Deviation of the visual field (PSD)

  3. visual acuity

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00435058
Lead sponsor
University of Sao Paulo
First posted
Feb 14, 2007
Start date
Sep 2005
Completion
Apr 2006
Last update
Feb 19, 2007

Study contacts

Tiago Prata, MD
principal investigator · Federal University of São Paulo
Luiz A Melo Jr, MD
principal investigator · Federal University of São Paulo
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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