Primary Open-angle GlaucomaNCT03673644
Impact of Glaucoma and Visual Field Loss on Life Space
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 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- Questionnaires
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2018to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- History of intra-ocular surgery other than uncomplicated cataract or glaucoma surgery
- Significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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 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).
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- Questionnaires
- 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.
QuestionnairesOther
Two questionnaires will be administered, one focusing on life space and the other focusing on low luminance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires |
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: Day one
Secondary outcomes (4)
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
Measured: Day one
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.
Measured: Day one
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.
Measured: Day one
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
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start9 Oct 2018
- Primary completion30 May 2019
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- 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
- NCT03673644
- Sponsor's protocol ID
- IRB-300001552
- Other IDs
- 5P30AG022838-14
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2018
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share our redacted individual participant data with other researchers at the time of sharing results.
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
- NCT03673644
- Acronym / sponsor ID
- IRB-300001552
- Conditions
- Primary Open-angle Glaucoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 17 Sep 2018 (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 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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Open-Angle Glaucoma | – | Other: QuestionnairesTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- History of intra-ocular surgery other than uncomplicated cataract or glaucoma surgery
- Significant cognitive impairment
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 |
|---|---|---|
| QuestionnairesTwo questionnaires will be administered, one focusing on life space and the other focusing on low luminance. | Other | Primary Open-Angle Glaucoma |
Primary outcome
Assessment of life space measured with the Life Space Questionnaire
Time frame: Day one
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.
4 secondary outcomes
Relationship between the Life Space Questionnaire and vision loss
Time frame: Day one
Assessment of vision under dim illumination and at night using the Low Luminance Questionnaire
Time frame: Day one
Relationship between Low Luminance Questionnaire and vision loss
Time frame: Day one
Relationship between the Low Luminance Questionnaire and the Life Space Questionnaire
Time frame: Day one
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: Undecided. We plan to share our redacted individual participant data with other researchers at the time of sharing results.
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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 4 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: Day one). 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.