Actively Recruiting
AMD and Validating Rod-Mediated Dark Adaptation With Everyday Task Performance
Led by Duke University · Updated on 2025-08-21
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the relationship between rod-mediated dark adaptation and everyday task performance, such as reading under dim light, in older adults with early and intermediate age-related macular degeneration (AMD), including those with subretinal drusenoid deposits, as well as in individuals with normal eye health. The study involves a cross-sectional design conducted at two sites with a total of 200 participants classified by AMD severity using the AREDS system. This research aims to understand how AMD severity affects these visual functions important for daily activities. Participants are grouped based on their diagnosis: early AMD, intermediate AMD, geographic atrophy, or healthy controls. The study includes comprehensive eye exams and uses a virtual reality headset called Streetlab VR to simulate walking through a maze at various light levels. The main study assessments include measuring rod-mediated dark adaptation, reading ability with the MNREAD chart, mobility through the Mobility Standardized Test, and evaluation of ellipsoid zone loss in the retina. Individuals will attend a single study visit lasting approximately 5 to 6 hours, during which all visual and mobility tests will be performed. Researchers will collect detailed demographic information, ocular history, and medication use. Outcomes measured include the extent of ellipsoid zone attenuation and performance on dark adaptation, reading, and mobility tasks. The study will analyze correlations between these measures across participant groups. Total participation involves only this one-time visit, with safety and data monitored throughout the study period ending in 2027.
CONDITIONS
Brief Title
AMD and Validation Rod-Meditated Dark Adaptation With Everyday Task Performance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable and willing to provide consent
- Diagnosed with early, intermediate dry age-related macular degeneration, geographic atrophy, or has a healthy macula
- At least 50 years old
You will not qualify if you...
- Unable or unwilling to give consent or unable to read consent
- Under 50 years old
- Dense cataracts in the study eye(s) affecting visual tests
- Glaucoma requiring treatment or visual field defects
- Previous retinal laser or surgical therapy in the study eye(s)
- Any other ocular condition requiring long-term therapy or surgery during the study
- Significant corneal or media opacities preventing adequate imaging and testing
- Diagnosis of nystagmus interfering with testing
- High myopia of -8 diopters or worse
- Any physical or mental condition that increases risk or interferes with study procedures, as judged by the Investigator
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit, approximately 5-6 hours
Participants undergo diagnostic tests including a comprehensive eye exam, rod-mediated dark adaptation testing, reading performance assessment, and mobility testing using the Streetlab VR headset to simulate walking through a maze at different light levels.
1 visit (in-person)
Duration - Approximately 2 years
Participants are observed for changes in ellipsoid zone band attenuation and disease progression over approximately 2 years.
Follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Duke Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
E
Eleonora Lad, MD, PhD
A
Alice Ventura
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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