Night-vision (rod) testing linked to everyday reading and mobility in AMD
AMD and Validating Rod-Meditated Dark Adaptation With Everyday Task Performance
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 89 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06619405 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.