Impact of Glaucoma and Visual Field Loss on Life Space

Primary Open-angle Glaucoma Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

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