Does Glaucoma Cause Loss of Brain Function?

NCT ID: NCT01303939

Last Updated: 2018-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

magnetic resonance imaging (MRI) of the brain

Intervention Type DIAGNOSTIC_TEST

High resolution three-dimensional T1-weighted magnetic resonance imaging (MRI) was obtained from each participant at one visit.

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.

Group Type OTHER

magnetic resonance imaging (MRI) of the brain

Intervention Type DIAGNOSTIC_TEST

High resolution three-dimensional T1-weighted magnetic resonance imaging (MRI) was obtained from each participant at one visit.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Brain MRI

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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George L. Spaeth MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George L Spaeth, MD

Role: PRINCIPAL_INVESTIGATOR

Glaucoma Service, Wills Eye Institute

Locations

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Wills Eye Institute, Glaucoma Service

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

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.

Reference Type RESULT

Williams AL. Correlation of brain volumes and patient-reported visual disability in glaucoma. AGS Annual Meeting, San Francisco, March 1, 2012

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 23838767 (View on PubMed)

Other Identifiers

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10-009

Identifier Type: -

Identifier Source: org_study_id

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