- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04396002
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lyne Racette, PhD
- Phone Number: 205-325-8673
- Email: lracette@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294-0001
- Recruiting
- University of Alabama Birmingham
-
Contact:
- Lyne Racette, PhD
- Phone Number: 205-325-8673
- Email: lracette@uabmc.edu
-
Principal Investigator:
- Lyne Racette, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Primary Open-Angle Glaucoma
Patients diagnosed with primary open-angle glaucoma.
|
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.
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.
Participants will be presented with visual targets of different contrast under dim illumination and asked to report when they see the target.
Sensitivity in the central visual area will be assessed under dim illumination
Participants will be asked to look at a fixation target and the density of their macular pigment will be assessed.
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.
|
Control
Participants with healthy eyes.
|
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.
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.
Participants will be presented with visual targets of different contrast under dim illumination and asked to report when they see the target.
Sensitivity in the central visual area will be assessed under dim illumination
Participants will be asked to look at a fixation target and the density of their macular pigment will be assessed.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
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.
|
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
|
Participants will be presented with targets of different spatial frequency at different contrasts.
Their sensitivity at each spatial frequency will be recorded/
|
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
|
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).
|
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
|
Participants will be presented with targets at different locations in their visual fields under dim illumination.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lyne Racette, PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300001552
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Open Angle Glaucoma
-
Omar SaidCompletedGlaucoma,Primary Open-Angle ,Primary Angle ClosureEgypt
-
Peking UniversityRecruitingPrimary Open Angle Glaucoma | Ocular Hypertension | Primary Open Angle Glaucoma of Both Eyes | Primary Open-Angle Glaucoma, Unspecified Eye | Suspect GlaucomaChina
-
Glaucot Teknoloji Anonim SirketiRecruitingPrimary Open-Angle GlaucomaTurkey
-
China Medical University HospitalRecruitingEffect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle GlaucomaPrimary Open-angle GlaucomaTaiwan
-
InnFocus Inc.CompletedPrimary Open-angle GlaucomaSpain, United States, United Kingdom, France, Italy
-
Glaukos CorporationTerminatedPrimary Open-Angle GlaucomaUnited States
-
Rehab mahmoud abdelhamid mohamedCairo UniversityCompletedPrimary Open-angle GlaucomaEgypt
-
Cairo UniversityUniversity of LuebeckUnknown
-
Xiaodong ZhouCompletedPrimary Open-angle Glaucoma
-
Qlaris Bio, Inc.RecruitingPrimary Open Angle Glaucoma of Both Eyes | Primary Open Angle Glaucoma (POAG) | Primary Open-Angle Glaucoma, Unspecified Eye | Ocular Hypertension (OHT)United States
Clinical Trials on Life Space Questionnaire
-
World BankRecruitingAdolescent Behavior | Sexual and Reproductive Health | Life Skills | Digital Skills | Earning OutcomesNigeria
-
University Hospital, Basel, SwitzerlandTerminatedRectal CancerSwitzerland
-
University Hospital, MontpellierPediatric and Congenital Cardiology Department of Necker-enfant malades University...CompletedQuality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years (QoL-CHD-5-7)Congenital Heart DiseaseFrance
-
Texas Tech University Health Sciences CenterTexas Tech UniversityRecruiting
-
Centre Hospitalier Universitaire DijonUnknownHeart Failure | Multiple Sclerosis | Hemophilia | Chronic Respiratory Failure | Horton's Disease | Chronic Coronary Syndrome | AMD and Macular Edema | Malignant HemopathyFrance
-
Ramsay Générale de SantéRecruitingGender Identity | TransgenderismFrance
-
ElsanEuropean Clinical Trial Experts Network; Belledonne clinicRecruitingQuality of Life | Aortic Valve Replacement | Transfemoral ApproachFrance
-
University of MessinaUniversità degli Studi di Ferrara; University of Pavia; Careggi Hospital; Fondazione...UnknownPatient-Reported Outcome Measures in Wild-Type and Variant Cardiac Transthyretin Amyloidosis (ITALY)Transthyretin AmyloidosisItaly
-
University College, LondonUnknownSensorineural Hearing Loss | Sensory Hearing Loss | Sensorineural Hearing Loss in Left Ear | Sensorineural Hearing Loss in Right Ear | Sensorineural HearingUnited Kingdom