Glaucoma
Conditions
Keywords
Glaucoma, MRI Brain Scan, Voxel-Based Morphometry
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.
Interventions
DIAGNOSTIC_TESTmagnetic resonance imaging (MRI) of the brain
High resolution three-dimensional T1-weighted magnetic resonance imaging (MRI) was obtained from each participant at one visit.
Sponsors
Wills Eye
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Brain Volume (Size) | 2 hours | Absolute volume (size) of inferior occipital gyrus L (a location in the brain structure) is measured in cubic millimeters (mm3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Volumes | 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. |
Countries
United States
Participant flow
Recruitment details
22 glaucoma patients were enrolled in this study. However, 7 age, gender and ethnic matched controls were not found for study comparisons. Therefore, only the 15 glaucoma patients who best matched the controls were included in the published analysis.
Participants by arm
| Arm | Count |
|---|---|
| Glaucoma Patients Patients who were outliers from the AARV or ADREV Studies. | 15 |
| Control Patients Age, gender and race matched group of healthy individuals with no ocular diseases. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Control Patients | Glaucoma Patients | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Continuous | 65.6 years STANDARD_DEVIATION 11.3 | 66.1 years STANDARD_DEVIATION 11.2 | 65.85 years STANDARD_DEVIATION 11.25 |
| Region of Enrollment United States | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 15 |
| other Total, other adverse events | 0 / 22 | 0 / 15 |
| serious Total, serious adverse events | 0 / 22 | 0 / 15 |
Outcome results
Primary
Absolute Brain Volume (Size)
Absolute volume (size) of inferior occipital gyrus L (a location in the brain structure) is measured in cubic millimeters (mm3).
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glaucoma Patients | Absolute Brain Volume (Size) | 3067 cubic millimeters (mm3) | Standard Deviation 903 |
| Control Patients | Absolute Brain Volume (Size) | 2302 cubic millimeters (mm3) | Standard Deviation 357 |
Secondary
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.
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Glaucoma Patients | Relative Volumes | 0.0037 cubic millimeters (mm3) | Standard Deviation 0.001 |
| Control Patients | Relative Volumes | 0.0029 cubic millimeters (mm3) | Standard Deviation 0.001 |