Does Glaucoma Cause Loss of Brain Function?

NCT01303939 | Completed Results FDA Device

• 1 other identifier: 10-009
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Glaucoma; MRI Brain Scan; Voxel-Based Morphometry

Outcome Measures

Primary Outcomes (1)

• Absolute Brain Volume (Size)

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

  2 hours

Secondary Outcomes (1)

• Relative Volumes

  2 hours

Study Arms (2)

Glaucoma Patients

OTHER

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

Control Patients

OTHER

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

Interventions

magnetic resonance imaging (MRI) of the brain DIAGNOSTIC_TEST

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

Also known as: Brain MRI

Control Patients; Glaucoma Patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wills Eye: lead

Study Sites (1)

Wills Eye Institute, Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (6)

• 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.

  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.

  RESULT

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

  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.

  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.

  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.

  PMID: 23838767 RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: George L. Spaeth, MD
• Organization: Wills Eye Hospital, Glaucoma Research Center

gspaeth@willseye.org

215-928-3123

Study Officials

• George L Spaeth, MD

  Glaucoma Service, Wills Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2013
• Last Updated: November 20, 2018
• Results First Posted: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)