Clinical trial NCT04396002: Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Official title: Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Open Angle Glaucoma
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of life space measured with the Life Space Questionnaire
timeFrame: Through study completion, an average of 1 year
measure: Assessment of vision under low luminance conditions
timeFrame: Through study completion, an average of 1 year
measure: Differences in contrast sensitivity functions between controls and patients
timeFrame: Through study completion, an average of 1 year
measure: Differences in dark adaptation between controls and patients
timeFrame: Through study completion, an average of 1 year
measure: Differences in visual sensitivity under dim illumination between controls and patients
timeFrame: Through study completion, an average of 1 year
measure: Differences in Macular Pigment Optical Density between controls and patients
timeFrame: Through study completion, an average of 1 year
measure: Assessment of the relationship between each the measure of visual function and life space
timeFrame: Through study completion, an average of 1 year
measure: Assessment of the relationship between each the measure of visual function and self-reported visual function under dim illumination
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Lyne Racette, PhD
role: PRINCIPAL_INVESTIGATOR
References: