Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT04396002

Conditions

Primary Open Angle Glaucoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Life Space Questionnaire

Low Luminance Questionnaire

Contrast sensitivity under dim illumination

Visual field under dim illumination (MAIA)

Macular Pigment Optical Density (MPOD)

Study Details

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.

Conditions

Primary Open Angle Glaucoma

Study ID

NCT04396002

Start date

Jun 1, 2019

Status verified date

Sep, 2025

Completion date

May 30, 2026

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary Open-Angle Glaucoma

Patients diagnosed with primary open-angle glaucoma.

Control

Participants with healthy eyes.

Interventions

Life Space Questionnaire

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

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

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)

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

Macular Pigment Optical Density (MPOD)

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

Dark Adaptation

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.

Primary outcome measure

  • Assessment of life space measured with the Life Space Questionnaire [ Time Frame: 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 ]
  • Differences in contrast sensitivity functions between controls and patients [ Time Frame: 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 ]
  • Differences in visual sensitivity under dim illumination between controls and patients [ Time Frame: 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 ]
  • Assessment of the relationship between each the measure of visual function and life space [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Lyne Racette, PhD

205-325-8673lracette@uabmc.edu

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35294-0001

Contacts

Lyne Racette, PhD

2053258673lracette@uabmc.edu

Principal Investigator:

Lyne Racette, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-09-12.