Primary Open Angle GlaucomaNCT04396002
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
An observational study of Primary Open Angle Glaucoma, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Life Space Questionnaire, Low Luminance Questionnaire and Contrast sensitivity under dim illumination
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
- No diagnosis of eye disease
Who cannot join
- 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)
- Cognitive impairment that would preclude ability to take the tests
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Birmingham
Birmingham, Alabama, 35294-0001
About this study
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.
Read the 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.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Life Space Questionnaire, Low Luminance Questionnaire, Contrast sensitivity under dim illumination, Visual field under dim illumination (MAIA), Macular Pigment Optical Density (MPOD)
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Space QuestionnaireDiagnostic test
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 QuestionnaireDiagnostic test
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 illuminationDiagnostic test
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)Diagnostic test
Sensitivity in the central visual area will be assessed under dim illumination
Macular Pigment Optical Density (MPOD)Diagnostic test
Participants will be asked to look at a fixation target and the density of their macular pigment will be assessed.
Dark AdaptationDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary Open-Angle Glaucoma | Patients diagnosed with primary open-angle glaucoma. Receives: Diagnostic Test: Life Space Questionnaire; Diagnostic Test: Low Luminance Questionnaire; Diagnostic Test: Contrast sensitivity under dim illumination; Diagnostic Test: Visual field under dim illumination (MAIA); Diagnostic Test: Macular Pigment Optical Density (MPOD); Diagnostic Test: Dark Adaptation | |
| Control | Participants with healthy eyes. Receives: Diagnostic Test: Life Space Questionnaire; Diagnostic Test: Low Luminance Questionnaire; Diagnostic Test: Contrast sensitivity under dim illumination; Diagnostic Test: Visual field under dim illumination (MAIA); Diagnostic Test: Macular Pigment Optical Density (MPOD); Diagnostic Test: Dark Adaptation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Assessment of vision under low luminance conditions
The Low Luminance Questionnaire is a 32-item questionnaire that assesses how participants see under dim illumination and how well they can perform different tasks (e.g. reading, driving). Patients are asked to select a response among different choices on a Likert scale that ranges from 1 to 5, 1 to 6, 1 to 7, or 1 to 8 depending on the question. A response of "1" indicates that the participant experiences no difficulty while increasingly higher numbers indicate increasing amounts of difficulty.
Measured: Through study completion, an average of 1 year
Differences in contrast sensitivity functions between controls and patients
Participants will be presented with targets of different spatial frequency at different contrasts. Their sensitivity at each spatial frequency will be recorded/
Measured: Through study completion, an average of 1 year
Differences in dark adaptation between controls and patients
Once participants have adapted to a dark environment, they will be exposed to a bright flash of light. The time needed to recover their visual sensitivity will be measured (rod-intercept time).
Measured: Through study completion, an average of 1 year
Differences in visual sensitivity under dim illumination between controls and patients
Participants will be presented with targets at different locations in their visual fields under dim illumination.
Measured: Through study completion, an average of 1 year
Differences in Macular Pigment Optical Density between controls and patients
Participants will fixate on a target while their MPOD is assessed. The MPOD is measured using the Heidelberg optical coherence tomography (OCT) MPOD module. Two different light sources are directed to the back of the eye. The light is reflected back and the OCT/MPOD computes the difference in the reflectance of the two lights which is an estimate of the density of macular pigment.
Measured: Through study completion, an average of 1 year
Assessment of the relationship between each the measure of visual function and life space
The relationship between each of the measures of visual function (dark adaptation, contrast sensitivity functions, visual fields under dim illumination, and MPOD) and life space (Life Space Questionnaire will be assessed.
Measured: 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
The relationship between each of the measures of visual function (dark adaptation, contrast sensitivity functions, visual fields under dim illumination, and MPOD) and self-reported visual performance under dim illumination (Low Luminance Questionnaire) will be assessed.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Jun 2019
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyne Racette, University of Alabama at Birmingham
- Investigators
- Lyne Racette, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396002
- Sponsor's protocol ID
- 300001552
- Other IDs
- 5P30AG022838-14
- Status last verified
- Sep 2026
- First submitted
- 12 May 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
- ClinicalTrials.gov ID
- NCT04396002
- Acronym / sponsor ID
- 300001552
- Conditions
- Primary Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Open-Angle Glaucoma | – | Diagnostic Test: Life Space Questionnaire, Diagnostic Test: Low Luminance Questionnaire, Diagnostic Test: Contrast sensitivity under dim illumination, Diagnostic Test: Visual field under dim illumination (MAIA), Diagnostic Test: Macular Pigment Optical Density (MPOD), Diagnostic Test: Dark AdaptationPatients diagnosed with primary open-angle glaucoma. |
| Control | – | Diagnostic Test: Life Space Questionnaire, Diagnostic Test: Low Luminance Questionnaire, Diagnostic Test: Contrast sensitivity under dim illumination, Diagnostic Test: Visual field under dim illumination (MAIA), Diagnostic Test: Macular Pigment Optical Density (MPOD), Diagnostic Test: Dark AdaptationParticipants with healthy eyes. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
- No diagnosis of eye disease
Key exclusion criteria (2 listed)
- 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)
- Cognitive impairment that would preclude ability to take the tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life Space QuestionnaireThis 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. | Diagnostic test | Control, Primary Open-Angle Glaucoma |
| Low Luminance QuestionnaireThis 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. | Diagnostic test | Control, Primary Open-Angle Glaucoma |
| Contrast sensitivity under dim illuminationParticipants will be presented with visual targets of different contrast under dim illumination and asked to report when they see the target. | Diagnostic test | Control, Primary Open-Angle Glaucoma |
| Visual field under dim illumination (MAIA)Sensitivity in the central visual area will be assessed under dim illumination | Diagnostic test | Control, Primary Open-Angle Glaucoma |
| 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. | Diagnostic test | Control, Primary Open-Angle Glaucoma |
| Dark AdaptationAfter 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. | Diagnostic test | Control, Primary Open-Angle Glaucoma |
Primary outcome
Assessment of life space measured with the Life Space Questionnaire
Time frame: Through study completion, an average of 1 year
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.
Assessment of vision under low luminance conditions
Time frame: Through study completion, an average of 1 year
The Low Luminance Questionnaire is a 32-item questionnaire that assesses how participants see under dim illumination and how well they can perform different tasks (e.g. reading, driving). Patients are asked to select a response among different choices on a Likert scale that ranges from 1 to 5, 1 to 6, 1 to 7, or 1 to 8 depending on the question. A response of "1" indicates that the participant experiences no difficulty while increasingly higher numbers indicate increasing amounts of difficulty.
Differences in contrast sensitivity functions between controls and patients
Time frame: Through study completion, an average of 1 year
Participants will be presented with targets of different spatial frequency at different contrasts. Their sensitivity at each spatial frequency will be recorded/
Differences in dark adaptation between controls and patients
Time frame: Through study completion, an average of 1 year
Once participants have adapted to a dark environment, they will be exposed to a bright flash of light. The time needed to recover their visual sensitivity will be measured (rod-intercept time).
Differences in visual sensitivity under dim illumination between controls and patients
Time frame: Through study completion, an average of 1 year
Participants will be presented with targets at different locations in their visual fields under dim illumination.
Differences in Macular Pigment Optical Density between controls and patients
Time frame: Through study completion, an average of 1 year
Participants will fixate on a target while their MPOD is assessed. The MPOD is measured using the Heidelberg optical coherence tomography (OCT) MPOD module. Two different light sources are directed to the back of the eye. The light is reflected back and the OCT/MPOD computes the difference in the reflectance of the two lights which is an estimate of the density of macular pigment.
Assessment of the relationship between each the measure of visual function and life space
Time frame: Through study completion, an average of 1 year
The relationship between each of the measures of visual function (dark adaptation, contrast sensitivity functions, visual fields under dim illumination, and MPOD) and life space (Life Space Questionnaire will be assessed.
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
The relationship between each of the measures of visual function (dark adaptation, contrast sensitivity functions, visual fields under dim illumination, and MPOD) and self-reported visual performance under dim illumination (Low Luminance Questionnaire) will be assessed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyne Racette, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of life space measured with the Life Space Questionnaire (time frame: Through study completion, an average of 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.