Does Glaucoma Cause Loss of Brain Function?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George L. Spaeth MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT01303939
First received: February 24, 2011
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neuroimaging Brain Changes in Glaucoma

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Brain atrophy [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Mini-Mental State Exam and T-1 weighted MRI brain scan and will be performed


Enrollment: 37
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Glaucoma Patients
Patients who were outliers from the AARV or ADREV Studies.
Control Patients
Age, gender and race matched group of healthy individuals with no ocular diseases.

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 MRI brain scans will reveal areas of cortical degeneration in glaucoma patients, and the extent of damage in these areas will correlate with their ability to perform vision-dependent tasks, as measured by the Assessment of Ability Related to Vision (AARV).

Patients with glaucoma who were outliers in Assessment of Ability Related to Vision (AARV) Study or Assessment of Disability related to vision (ADREV) Study, in that they have 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Glaucoma Service, Wills Eye Institute

Criteria

Inclusion Criteria:

  • Patients with glaucoma who were outliers in Assessment of Ability Related to Vision (AARV) or Assessment of Disability related to vision (ADREV), in that they have poor performance-based measure scores (≤ 40s) 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 the neuro-ophthalmologic examination.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303939

Locations
United States, Pennsylvania
Wills Eye Institute, Glaucoma Service
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Investigators
Principal Investigator: George L Spaeth, MD Glaucoma Service, Wills Eye Institute
  More Information

Publications:
Williams AL, Lackey J, Wizov S, Gatla S, Sergott R, Chia T, Lai S, Spaeth GL. Correlation of brain volumes and functional deficits in glaucoma. Association of Research in Vision and Ophthalmology, 5624 May 10, 2012.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George L. Spaeth MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01303939     History of Changes
Other Study ID Numbers: 10-009
Study First Received: February 24, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
Glaucoma
MRI Brain Scan

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 21, 2014