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Does Glaucoma Cause Loss of Brain Function?

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
magnetic resonance imaging (MRI) of the brain
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glaucoma focused on measuring Glaucoma, MRI Brain Scan, Voxel-Based Morphometry

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wills Eye Institute, Glaucoma Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Glaucoma Patients

Control Patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Absolute Brain Volume (Size)
Absolute volume (size) of inferior occipital gyrus L (a location in the brain structure) is measured in cubic millimeters (mm3).

Secondary Outcome Measures

Relative Volumes
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.

Full Information

First Posted
February 24, 2011
Last Updated
November 16, 2018
Sponsor
Wills Eye
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1. Study Identification

Unique Protocol Identification Number
NCT01303939
Brief Title
Does Glaucoma Cause Loss of Brain Function?
Official Title
Neuroimaging Brain Changes in Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (Actual)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, MRI Brain Scan, Voxel-Based Morphometry

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glaucoma Patients
Arm Type
Other
Arm Description
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.
Arm Title
Control Patients
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
magnetic resonance imaging (MRI) of the brain
Other Intervention Name(s)
Brain MRI
Intervention Description
High resolution three-dimensional T1-weighted magnetic resonance imaging (MRI) was obtained from each participant at one visit.
Primary Outcome Measure Information:
Title
Absolute Brain Volume (Size)
Description
Absolute volume (size) of inferior occipital gyrus L (a location in the brain structure) is measured in cubic millimeters (mm3).
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Relative Volumes
Description
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.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George L Spaeth, MD
Organizational Affiliation
Glaucoma Service, Wills Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Institute, Glaucoma Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
Williams AL. Correlation of brain volumes and patient-reported visual disability in glaucoma. AGS Annual Meeting, San Francisco, March 1, 2012
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
23838767
Citation
Williams AL, Lackey J, Wizov SS, Chia TM, Gatla S, Moster ML, Sergott R, Spaeth GL, Lai S. Evidence for widespread structural brain changes in glaucoma: a preliminary voxel-based MRI study. Invest Ophthalmol Vis Sci. 2013 Aug 28;54(8):5880-7. doi: 10.1167/iovs.13-11776.
Results Reference
result

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Does Glaucoma Cause Loss of Brain Function?

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