Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults

June 14, 2023 updated by: Lyne Racette, University of Alabama at Birmingham
Mobility refers to a person's purposeful movement through the environment from one place to another and can be conceptualized as a continuum from bed bound (immobility) on one extreme to making excursions to distant locations on the other extreme. Primary open-angle glaucoma (POAG) is a chronic, progressive optic neuropathy that can lead to gradual loss of vision in the peripheral field and central vision. Older adults with POAG have an increased risk for motor vehicle collisions and falls. Moreover, existing studies suggest that patients with POAG exhibit more postural sway while standing as measured by a balance platform and also tend to walk more slowly than those who are normally sighted and free of ocular disease. While these disturbances likely influence mobility, there has been little research directly assessing the impact of POAG on mobility. This study will assess the impact of POAG on life space (one aspect of mobility) and will determine whether difficulties with life space are associated with difficulties experienced under conditions of dim lighting.

Study Overview

Detailed Description

Aim 1: To determine whether differences exist between people with healthy eyes and patients with POAG in seeing under dim illumination (Low Luminance Questionnaire) and to determine whether such differences are associated with life space.

Aim 2: To determine whether differences exist between people with healthy eyes and patients with POAG in seeing under dim illumination (objective measures of visual function) and to determine whether such differences are associated with life space.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35294-0001
        • Recruiting
        • University of Alabama Birmingham
        • Contact:
        • Principal Investigator:
          • Lyne Racette, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients:

Participants that are enrolled in the Early Detection of Glaucoma Progression using a Novel Individualized Approach (IRB-300000301) or in the African Descent and Glaucoma Evaluation (ADAGES) IV: Alterations of the Lamina Cribrosa in Progression (IRB-161115004).

Controls:

Participants with healthy eyes will be recruited.

Description

Inclusion Criteria (Patients):

  • Participants that are enrolled in the Early Detection of Glaucoma Progression using a Novel Individualized Approach (IRB-300000301) or in the African Descent and Glaucoma Evaluation (ADAGES) IV: Alterations of the Lamina Cribrosa in Progression (IRB-161115004).

Exclusion Criteria (Patients):

  • Not being enrolled in one of the following two NIH-funded studies: 1. African Descent and Glaucoma Evaluation (ADAGES) IV: Alterations of the lamina cribrosa in progression (EY026574) or 2. Early detection of glaucoma progression using a novel individualized approach (EY025756)

Inclusion Criteria (Controls):

  • No diagnosis of eye disease

Exclusion Criteria (Controls):

  • Cognitive impairment that would preclude ability to take the tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Open-Angle Glaucoma
Patients diagnosed with primary open-angle glaucoma.
This 9-item questionnaire is interested in finding out 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.
This 32-item questionnaire is interested in finding out problems that involve vision under different lighting conditions or feelings that people have about your vision under different lighting conditions.
Participants will be presented with visual targets of different contrast under dim illumination and asked to report when they see the target.
Sensitivity in the central visual area will be assessed under dim illumination
Participants will be asked to look at a fixation target and the density of their macular pigment will be assessed.
After adapting to a dark environment, participants will be exposed a bright flask of light. the time needed for them to recover their sensitivity will be measured.
Control
Participants with healthy eyes.
This 9-item questionnaire is interested in finding out 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.
This 32-item questionnaire is interested in finding out problems that involve vision under different lighting conditions or feelings that people have about your vision under different lighting conditions.
Participants will be presented with visual targets of different contrast under dim illumination and asked to report when they see the target.
Sensitivity in the central visual area will be assessed under dim illumination
Participants will be asked to look at a fixation target and the density of their macular pigment will be assessed.
After adapting to a dark environment, participants will be exposed a bright flask of light. the time needed for them to recover their sensitivity will be measured.

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: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
Assessment of vision under low luminance conditions
Time Frame: Through study completion, an average of 1 year
The Low Luminance Questionnaire is a 32-item questionnaire that assesses how participants see under dim illumination and how well they can perform different tasks (e.g. reading, driving). Patients are asked to select a response among different choices on a Likert scale that ranges from 1 to 5, 1 to 6, 1 to 7, or 1 to 8 depending on the question. A response of "1" indicates that the participant experiences no difficulty while increasingly higher numbers indicate increasing amounts of difficulty.
Through study completion, an average of 1 year
Differences in contrast sensitivity functions between controls and patients
Time Frame: Through study completion, an average of 1 year
Participants will be presented with targets of different spatial frequency at different contrasts. Their sensitivity at each spatial frequency will be recorded/
Through study completion, an average of 1 year
Differences in dark adaptation between controls and patients
Time Frame: Through study completion, an average of 1 year
Once participants have adapted to a dark environment, they will be exposed to a bright flash of light. The time needed to recover their visual sensitivity will be measured (rod-intercept time).
Through study completion, an average of 1 year
Differences in visual sensitivity under dim illumination between controls and patients
Time Frame: Through study completion, an average of 1 year
Participants will be presented with targets at different locations in their visual fields under dim illumination.
Through study completion, an average of 1 year
Differences in Macular Pigment Optical Density between controls and patients
Time Frame: Through study completion, an average of 1 year
Participants will fixate on a target while their MPOD is assessed. The MPOD is measured using the Heidelberg optical coherence tomography (OCT) MPOD module. Two different light sources are directed to the back of the eye. The light is reflected back and the OCT/MPOD computes the difference in the reflectance of the two lights which is an estimate of the density of macular pigment.
Through study completion, an average of 1 year
Assessment of the relationship between each the measure of visual function and life space
Time Frame: Through study completion, an average of 1 year
The relationship between each of the measures of visual function (dark adaptation, contrast sensitivity functions, visual fields under dim illumination, and MPOD) and life space (Life Space Questionnaire will be assessed.
Through study completion, an average of 1 year
Assessment of the relationship between each the measure of visual function and self-reported visual function under dim illumination
Time Frame: Through study completion, an average of 1 year
The relationship between each of the measures of visual function (dark adaptation, contrast sensitivity functions, visual fields under dim illumination, and MPOD) and self-reported visual performance under dim illumination (Low Luminance Questionnaire) will be assessed.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lyne Racette, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 300001552

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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