NCT00435058

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
Last Updated

February 19, 2007

Status Verified

February 1, 2007

First QC Date

February 12, 2007

Last Update Submit

February 16, 2007

Conditions

Glaucoma

Keywords

intraocular pressurecontrast sensitivityvisual function

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

timolol maleate 0,5%DRUG
brimonidine tartrate 0,2%DRUG
travoprost 0,004%DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Tiago Prata, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Luiz A Melo Jr, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 14, 2007

Study Start

September 1, 2005

Study Completion

April 1, 2006

Last Updated

February 19, 2007

Record last verified: 2007-02