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Clinical Trials/NCT01303939
NCT01303939
Completed
Not Applicable

Neuroimaging Brain Changes in Glaucoma

Wills Eye1 site in 1 country37 target enrollmentAugust 2010
ConditionsGlaucoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma
Sponsor
Wills Eye
Enrollment
37
Locations
1
Primary Endpoint
Absolute Brain Volume (Size)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
August 2013
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Wills Eye
Responsible Party
Principal Investigator
Principal Investigator

George L. Spaeth MD

Principal Investigator

Wills Eye

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Relative Volumes(2 hours)

Study Sites (1)

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