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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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)

No diagnosis of eye disease

Cognitive impairment that would preclude ability to take the tests

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Life Space Questionnaire

    Diagnostic test

    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.

  • Low Luminance Questionnaire

    Diagnostic test

    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.

  • Contrast sensitivity under dim illumination

    Diagnostic test

    Participants will be presented with visual targets of different contrast under dim illumination and asked to report when they see the target.

  • Visual field under dim illumination (MAIA)

    Diagnostic test

    Sensitivity in the central visual area will be assessed under dim illumination

  • Macular Pigment Optical Density (MPOD)

    Diagnostic test

    Participants will be asked to look at a fixation target and the density of their macular pigment will be assessed.

  • Dark Adaptation

    Diagnostic test

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Primary Open-Angle Glaucoma6 interventions
Group B: Control6 interventions

Trial outcomes

Primary outcomes

1

Assessment of life space measured with the Life Space Questionnaire

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.

Time frame
Through study completion, an average of 1 year
2

Assessment of vision under low luminance conditions

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.

Time frame
Through study completion, an average of 1 year
3

Differences in contrast sensitivity functions between controls and patients

Participants will be presented with targets of different spatial frequency at different contrasts. Their sensitivity at each spatial frequency will be recorded/

Time frame
Through study completion, an average of 1 year
4

Differences in dark adaptation between controls and patients

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).

Time frame
Through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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