Trial Outcomes & Findings for Does Glaucoma Cause Loss of Brain Function? (NCT NCT01303939)
NCT ID: NCT01303939
Last Updated: 2018-11-20
Results Overview
Absolute volume (size) of inferior occipital gyrus L (a location in the brain structure) is measured in cubic millimeters (mm3).
COMPLETED
NA
37 participants
2 hours
2018-11-20
Participant Flow
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.
Participant milestones
| Measure |
Glaucoma Patients
Patients were outliers from two previous studies: Assessment of Ability Related to Vision (AARV) or Assessment of Disability Related to Vision (ADREV).
|
Control Patients
Age, gender and race matched (to the glaucoma patients) group of healthy individuals with no ocular diseases.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Glaucoma Cause Loss of Brain Function?
Baseline characteristics by cohort
| Measure |
Glaucoma Patients
n=15 Participants
Patients who were outliers from the AARV or ADREV Studies.
|
Control Patients
n=15 Participants
Age, gender and race matched group of healthy individuals with no ocular diseases.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
65.85 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursAbsolute volume (size) of inferior occipital gyrus L (a location in the brain structure) is measured in cubic millimeters (mm3).
Outcome measures
| Measure |
Glaucoma Patients
n=15 Participants
Patients who were outliers from the AARV or ADREV Studies.
|
Control Patients
n=15 Participants
Age, gender and race matched group of healthy individuals with no ocular diseases.
|
|---|---|---|
|
Absolute Brain Volume (Size)
|
3067 cubic millimeters (mm3)
Standard Deviation 903
|
2302 cubic millimeters (mm3)
Standard Deviation 357
|
SECONDARY outcome
Timeframe: 2 hoursRelative 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.
Outcome measures
| Measure |
Glaucoma Patients
n=15 Participants
Patients who were outliers from the AARV or ADREV Studies.
|
Control Patients
n=15 Participants
Age, gender and race matched group of healthy individuals with no ocular diseases.
|
|---|---|---|
|
Relative Volumes
|
0.0037 cubic millimeters (mm3)
Standard Deviation 0.001
|
0.0029 cubic millimeters (mm3)
Standard Deviation 0.001
|
Adverse Events
Glaucoma Patients
Control Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
George L. Spaeth, MD
Wills Eye Hospital, Glaucoma Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place