Does Glaucoma Cause Loss of Brain Function?

November 16, 2018 updated by: George L. Spaeth MD, Wills Eye

Neuroimaging Brain Changes in Glaucoma

The purpose of the study is to determine if glaucoma is associated with neurodegenerative changes in areas of the brain other than the occipital lobe. This will help guide the direction of further research in the use of neuroprotective agents in preventing or controlling such changes. The final goal is to improve the quality of life for patients with glaucoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Death of retinal ganglion cells causes loss of neurons in areas other than just the visual cortex. These neurodegenerative changes decrease the patient's ability to perform the activities of daily living. Tensor-based morphometry analysis of magnetic resonance imaging (MRI) brain scans will reveal areas of cortical degeneration in glaucoma patients, and the extent of damage in these areas should correlate with patients ability to perform vision-dependent tasks, as measured by the Assessment of Ability Related to Vision (AARV).

Patients with glaucoma who were outliers in two previous studies, Assessment of Ability Related to Vision (AARV) or Assessment of Disability related to vision (ADREV), in that they had poor performance-based measure scores despite having midrange visual field scores.

Mini-Mental State Exam and T-1 weighted MRI brain scan and will be performed.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Institute, Glaucoma Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with glaucoma who were participated in other studies Assessment of Ability Related to Vision (AARV) or Assessment of Disability Related to Vision (ADREV) and were found to be outliers in that they have poor performance-based measure scores (≤ 40) despite having midrange visual field scores (mean deviation of -6 to -20).
  • Age-, gender- and race-matched controls who do not have glaucoma, and who do not have loss of vision for any reason other than cataract or refractive error.

Exclusion Criteria:

  1. Patients with any type of neurological disease.
  2. Patients with a cognitive deficit which would affect visual functioning, as revealed by score of less than 25 in the mini mental status examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Glaucoma Patients
Patients who were outliers from two previous studies: Assessment of Ability Related to Vision (AARV) or Assessment of Disability Related to Vision (ADREV) with mini mental status exam score of 25 or higher underwent magnetic resonance imaging (MRI) of the brain to look at structures and volume.
Diagnostic test: magnetic resonance imaging (MRI) of the brain
High resolution three-dimensional T1-weighted magnetic resonance imaging (MRI) was obtained from each participant at one visit.
Other Names:
  • Brain MRI
Other: Control Patients
Age, gender and race matched (to each glaucoma patient) group of healthy individuals with no ocular diseases with mini mental status exam score of 25 or higher underwent magnetic resonance imaging (MRI) of the brain to look at structures and volume.
Diagnostic test: magnetic resonance imaging (MRI) of the brain
High resolution three-dimensional T1-weighted magnetic resonance imaging (MRI) was obtained from each participant at one visit.
Other Names:
  • Brain MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Brain Volume (Size)
Time Frame: 2 hours
Absolute volume (size) of inferior occipital gyrus L (a location in the brain structure) is measured in cubic millimeters (mm3).
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative Volumes
Time Frame: 2 hours
Relative volume is calculated by dividing the absolute volume of inferior occipital gyrus L (a location in the brain structure) by that individual's total brain volume.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wills Eye

Investigators

  • Principal Investigator: George L Spaeth, MD, Glaucoma Service, Wills Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimate)

February 25, 2011

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glaucoma

Clinical Trials on magnetic resonance imaging (MRI) of the brain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe