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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03673644
Other study ID # IRB-300001552
Secondary ID 5P30AG022838-14
Status Active, not recruiting
Phase
First received
Last updated
Start date October 9, 2018
Est. completion date May 30, 2024

Study information

Verified date August 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 88
Est. completion date May 30, 2024
Est. primary completion date May 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Questionnaires
Two questionnaires will be administered, one focusing on life space and the other focusing on low luminance.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day one
Secondary Relationship between the Life Space Questionnaire and vision loss The results obtained on the Life Space Questionnaire will be correlated with the results of the visual field tests Day one
Secondary Assessment of vision under dim illumination and at night using the Low Luminance Questionnaire 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
Secondary Relationship between Low Luminance Questionnaire and vision loss The results obtained on the Low Luminance Questionnaire will be correlated with the results of the visual field tests. Day one
Secondary Relationship between the Low Luminance Questionnaire and the Life Space Questionnaire The results of the Low Luminance Questionnaire will be correlated with the results of the Life Space Questionnaire Day one
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