- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03673644
Impact of Glaucoma and Visual Field Loss on Life Space
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim 1: To examine the extent of life space in older adults with POAG using the Life Space Questionnaire and to examine whether life space in persons with POAG is associated with the magnitude of visual field impairment.
Aim 2: To examine difficulties seeing under dim illumination and at night in older adults with POAG using the Low Luminance Questionnaire and to examine whether greater difficulty in seeing under dim illumination and at night is related to the magnitude of visual field loss.
Aim 3: To examine the relationship in older adults with POAG between visual problems seeing under dim illumination and at night (Low Luminance Questionnaire) and their life space (Life Space Questionnaire).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis of primary open-angle glaucoma
- Best-corrected visual acuity of 20/40 or better
- Spherical refraction within ± 5 Diopters
- Cylinder refraction within ± 3 Diopters
Exclusion Criteria:
- History of intra-ocular surgery other than uncomplicated cataract or glaucoma surgery
- Significant cognitive impairment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Primary Open-Angle Glaucoma
Two following two questionnaires will be administered:
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Two questionnaires will be administered, one focusing on life space and the other focusing on low luminance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of life space measured with the Life Space Questionnaire
Time Frame: Day one
|
The Life Space Questionnaire is a 9-item questionnaire that assesses how much a person gets out and about and the spatial extent of the person's typical life space, i.e., what is the usual range of places in which the person engages in activities within the designated time frame.
Patients are asked to respond either Yes or No.
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Day one
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationship between the Life Space Questionnaire and vision loss
Time Frame: Day one
|
The results obtained on the Life Space Questionnaire will be correlated with the results of the visual field tests
|
Day one
|
|
Assessment of vision under dim illumination and at night using the Low Luminance Questionnaire
Time Frame: Day one
|
The Low Luminance Questionnaire is a 32-item questionnaire that assesses problems that involve vision under different lighting conditions or feelings about vision under different lighting conditions.
The range of responses is different for different questions, with the overall pattern being that "1" means "No difficulty at all" and that increasingly higher numbers mean increasingly more difficulty.
|
Day one
|
|
Relationship between Low Luminance Questionnaire and vision loss
Time Frame: Day one
|
The results obtained on the Low Luminance Questionnaire will be correlated with the results of the visual field tests.
|
Day one
|
|
Relationship between the Low Luminance Questionnaire and the Life Space Questionnaire
Time Frame: Day one
|
The results of the Low Luminance Questionnaire will be correlated with the results of the Life Space Questionnaire
|
Day one
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lyne Racette, PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300001552
- 5P30AG022838-14 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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