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Visual Function Changes After Intraocular Pressure Reduction

Primary Purpose

Glaucoma

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

timolol maleate 0,5%

brimonidine tartrate 0,2%

travoprost 0,004%

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring intraocular pressure, contrast sensitivity, visual function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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

Full Information

NCT ID

NCT00435058

First Posted

February 12, 2007

Last Updated

February 16, 2007

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00435058

Brief Title

Visual Function Changes After Intraocular Pressure Reduction

Official Title

Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Sao Paulo

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

intraocular pressure, contrast sensitivity, visual function

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

54 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

timolol maleate 0,5%

Intervention Type

Drug

Intervention Name(s)

brimonidine tartrate 0,2%

Intervention Type

Drug

Intervention Name(s)

travoprost 0,004%

Primary Outcome Measure Information:

Title

intraocular pressure

Title

contrast sensitivity

Title

visual quality perception

Secondary Outcome Measure Information:

Title

Mean deviation of the visual field (MD)

Title

Pattern Standard Deviation of the visual field (PSD)

Title

visual acuity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tiago Prata, MD

Organizational Affiliation

Federal University of Sao Paulo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luiz A Melo Jr, MD

Organizational Affiliation

Federal University of Sao Paulo

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Visual Function Changes After Intraocular Pressure Reduction

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