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Does Glaucoma Cause Loss of Brain Function?

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ClinicalTrials.gov Identifier: NCT01303939
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
George L. Spaeth MD, Wills Eye

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.

Condition or disease Intervention/treatment Phase
Glaucoma Diagnostic Test: magnetic resonance imaging (MRI) of the brain Not Applicable

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  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Magnetic resonance images (MRI) of the brain were obtained from glaucoma patients to look at structures and volume. Age, gender, ethnic healthy matches for each glaucoma patient received MRIs of the brain for comparison.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neuroimaging Brain Changes in Glaucoma
Actual Study Start Date : August 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma MRI Scans

Arm Intervention/treatment
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 Name: Brain MRI

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 Name: Brain MRI




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Lackey J, Williams AL, Gatla S, Wizov SS, Chia T, Spaeth G, Lai S. Structural changes in glaucoma: A volumetric MRI study. Association for Research in Vision and Ophthalmology, 730/A396May 2012.
Williams AL, Lackey J, Gatla S, Wizov SS, Sergott R, Chia T, Lai S, Spaeth GL. Correlation of brain volumes and function deficits in glaucoma. 148th Annual AOS Meeting, Charleston, SC 2012.
Williams AL. Correlation of brain volumes and patient-reported visual disability in glaucoma. AGS Annual Meeting, San Francisco, March 1, 2012
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.
Spaeth Gl, Williams AL, Lackey J, Gatla S, Wizov SS, Sergot R, Chia T, Lai S. Glaucoma and the whole patient. AAO 2012 Joint Meeting, Chicago Nov 12, 2012.

Responsible Party: George L. Spaeth MD, Principal Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01303939     History of Changes
Other Study ID Numbers: 10-009
First Posted: February 25, 2011    Key Record Dates
Results First Posted: November 20, 2018
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by George L. Spaeth MD, Wills Eye:
Glaucoma
MRI Brain Scan
Voxel-Based Morphometry

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases