NCT06619405 · Duke University
AMD and Validation Rod-Meditated Dark Adaptation With Everyday Task Performance
What this study is about
The goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod photoreceptors.
View original scientific description
The goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod photoreceptors.
Interventions
DIAGNOSTIC_TEST
Streetlab VR
Streetlab VR is a virtual reality headset that is warn to simulate walking through a maze at different light levels.
Primary outcome measures
Total number of participants with total ellipsoid zone (EZ) band attenuation
Time frame: Approximately 2 years
Total EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness = 0 μm.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Capable and willing to provide consent
- Has been diagnosed with early, intermediate dry age-related macular degeneration or geographic atrophy or has a healthy macular for controls
- At least 50 years of age
Exclusion criteria
- Unable or unwilling to give consent or unable to read consent since the study involves testing which requires reading
- Under 50 years of age
- Presence of dense cataracts in the study eye (s) that can affect visual function tests
- Presence of glaucoma requiring treatment during the study and/or visual field defects
- Previous retinal laser or surgical therapy in the study eye(s)
- Previous retinal laser or surgical therapy in the study eye(s)
- Any other ocular condition requiring long-term therapy or surgery during the study
- The participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing
- Diagnosis of nystagmus that will interfere with testing
- High myopia -8 Diopters or more severe
- The participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments.
Where
- Durham, North Carolina
Collaborators
Boehringer Ingelheim, StreetLab Vision
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2025 · Source of record for eligibility and locations