Night-vision (rod) testing linked to everyday reading and mobility in AMD
Official title: AMD and Validating Rod-Meditated Dark Adaptation With Everyday Task Performance
Run by Duke University · NCT06619405 · Data updated 2026-11-12
We will test whether reduced night vision (rod-mediated dark adaptation) is linked to reading and mobility performance in people 50 and older with early or intermediate AMD, subretinal drusenoid deposits, or healthy maculas.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 89 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | August 15, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | January 31, 2028 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT06619405 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 50 or older who can give informed consent and read, and who have early or intermediate dry AMD (including SDD) or healthy macular status, without dense cataract, glaucoma with field loss, recent retinal surgery, or other media opacities.
✕Probably not a fit
People with advanced neovascular AMD, significant corneal or media opacities, dense cataracts, glaucoma with visual field defects, nystagmus, or recent retinal laser or surgery are unlikely to benefit or may be ineligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a cross-sectional, single timepoint study conducted at two clinical sites aiming to enroll 200 participants stratified by AREDS 9-step classification with oversampling of intermediate AMD. Each participant will undergo a comprehensive eye exam, rod-mediated dark adaptation testing, standardized reading performance (MNREAD), mobility (MOST/StreetLab VR) testing, and retinal imaging to evaluate ellipsoid zone changes. Investigators will collect demographics, ocular history, and medication use from the record and compute correlations between dark adaptation and functional performance for the overall sample, within disease groups, and for those with SDD. The planned sample size gives ~80% power to detect a correlation of at least 0.20 overall and at least 0.40 within subgroups.
Why it matters
Potential benefit: If successful, this work could help clinicians detect functional vision problems earlier and provide validated outcome measures for interventions aimed at people with early or intermediate AMD.
How similar studies have gone: Prior research has linked rod-mediated dark adaptation to AMD-related visual dysfunction, but the specific relationship to MNREAD reading performance and MOST mobility tasks has not been established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
Duke Eye Center
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Eleonora Lad, MD, PhD — Duke University
- Study coordinator: Eleonora Lad, MD, PhD
- Email: nora.lad@duke.edu
- Phone: 919-684-4359
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Understanding Age-Related Macular Degeneration and Its Progression
This study looks at how age-related macular degeneration develops and progresses by comparing people with the condition to healthy individuals, using non-invasive tests and personal feedback.
-
Blepharoptosis After Repeated Anti-VEGF Injections in One Eye
This study tests whether repeated intravitreal anti-VEGF injections in one eye affect eyelid position compared with the untreated fellow eye.
-
First-in-human test of ARO-033 in adults
This study tests whether ARO-033 is safe and tolerable, and how it behaves in the body, in healthy adults and in adults with age-related macular degeneration.
-
Predicting Risk of AMD Progression Using Imaging in Aging Eyes
Researchers are test a new screening approach to detect early AMD and monitor its progression in adults 55 and older, to see if personalized monitoring can help in community settings.
-
C.001 for retinal degeneration: a first-in-human dose-escalation safety test
A first-in-human study will test the safety and tolerability of a single subretinal injection of C.001 in adults with retinal diseases involving retinal pigment epithelium degeneration.
-
Central microperimetry and radial OCT in geographic atrophy
We will test whether central microperimetry and radial OCT scans can more accurately measure how geographic atrophy progresses toward the fovea in people with or at risk for GA from age-related macular degeneration.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.