Clinical trial NCT01303939: Does Glaucoma Cause Loss of Brain Function?
Official title: Neuroimaging Brain Changes in Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
MRI Brain Scan
Voxel-Based Morphometry
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.

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:

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.

Primary outcomes:
measure: Absolute Brain Volume (Size)
timeFrame: 2 hours
Secondary outcomes:
measure: Relative Volumes
timeFrame: 2 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Institute, Glaucoma Service
state: Pennsylvania
Study officials:
affiliation: Glaucoma Service, Wills Eye Institute
name: George L Spaeth, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Williams AL. Correlation of brain volumes and patient-reported visual disability in glaucoma. AGS Annual Meeting, San Francisco, March 1, 2012
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.
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.
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.