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Does Glaucoma Cause Loss of Brain Function?

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ClinicalTrials.gov Identifier: NCT01303939
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
George L. Spaeth MD, Wills Eye

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Glaucoma
Intervention Diagnostic Test: magnetic resonance imaging (MRI) of the brain
Enrollment 37
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.
Pre-assignment Details  
Arm/Group Title Glaucoma Patients Control Patients
Hide Arm/Group Description Patients were outliers from two previous studies: Assessment of Ability Related to Vision (AARV) or Assessment of Disability Related to Vision (ADREV). Age, gender and race matched (to the glaucoma patients) group of healthy individuals with no ocular diseases.
Period Title: Overall Study
Started 22 15
Completed 15 [1] 15
Not Completed 7 0
[1]
Matched controls not found for comparisons. Only best matched glaucoma patients were included.
Arm/Group Title Glaucoma Patients Control Patients Total
Hide Arm/Group Description Patients who were outliers from the AARV or ADREV Studies. Age, gender and race matched group of healthy individuals with no ocular diseases. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
All participants completed mini mental status examination with score of 25 or greater then received high resolution 3D T1 weighted magnetic resonance imaging. Seven of the glaucoma patients did not have a control for comparison.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  46.7%
9
  60.0%
16
  53.3%
>=65 years
8
  53.3%
6
  40.0%
14
  46.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
66.1  (11.2) 65.6  (11.3) 65.85  (11.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
5
  33.3%
5
  33.3%
10
  33.3%
Male
10
  66.7%
10
  66.7%
20
  66.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15
 100.0%
15
 100.0%
30
 100.0%
1.Primary Outcome
Title Absolute Brain Volume (Size)
Hide Description Absolute volume (size) of inferior occipital gyrus L (a location in the brain structure) is measured in cubic millimeters (mm3).
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glaucoma Patients Control Patients
Hide Arm/Group Description:
Patients who were outliers from the AARV or ADREV Studies.
Age, gender and race matched group of healthy individuals with no ocular diseases.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: cubic millimeters (mm3)
3067  (903) 2302  (357)
2.Secondary Outcome
Title Relative Volumes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glaucoma Patients Control Patients
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: cubic millimeters (mm3)
0.0037  (0.001) 0.0029  (0.001)
Time Frame 2 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glaucoma Patients Control Patients
Hide Arm/Group Description Patients who were outliers from the AARV or ADREV Studies. Age, gender and race matched group of healthy individuals with no ocular diseases.
All-Cause Mortality
Glaucoma Patients Control Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Glaucoma Patients Control Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glaucoma Patients Control Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: George L. Spaeth, MD
Organization: Wills Eye Hospital, Glaucoma Research Center
Phone: 215-928-3123
Publications of Results:
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.
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.
Williams AL. Correlation of brain volumes and patient-reported visual disability in glaucoma. AGS Annual Meeting, San Francisco, March 1, 2012
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.
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.
Responsible Party: George L. Spaeth MD, Wills Eye
ClinicalTrials.gov Identifier: NCT01303939     History of Changes
Other Study ID Numbers: 10-009
First Submitted: February 24, 2011
First Posted: February 25, 2011
Results First Submitted: May 15, 2017
Results First Posted: November 20, 2018
Last Update Posted: November 20, 2018