NCT03673644

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Oct 2018May 2026

First Submitted

Initial submission to the registry

September 11, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

September 11, 2018

Last Update Submit

September 4, 2025

Conditions

Outcome Measures

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.

    Day one

Secondary Outcomes (4)

  • Relationship between the Life Space Questionnaire and vision loss

    Day one

  • Assessment of vision under dim illumination and at night using the Low Luminance Questionnaire

    Day one

  • Relationship between Low Luminance Questionnaire and vision loss

    Day one

  • Relationship between the Low Luminance Questionnaire and the Life Space Questionnaire

    Day one

Study Arms (1)

Primary Open-Angle Glaucoma

Two following two questionnaires will be administered: 1. 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. 2. 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.

Other: Questionnaires

Interventions

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

Primary Open-Angle Glaucoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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).

You may qualify if:

  • 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

You may not qualify if:

  • History of intra-ocular surgery other than uncomplicated cataract or glaucoma surgery
  • Significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lyne Racette, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 17, 2018

Study Start

October 9, 2018

Primary Completion

May 30, 2019

Study Completion (Estimated)

May 30, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations