Duke Eye Center
Durham, North Carolina, 27710, United States
Location status: Recruiting
NCT Number: NCT06619405
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.
Interested in participating?
Request Info50 year–89 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Location status: Recruiting
The investigators propose two sites for the study, Duke University and UAB. Each site will enroll 100 participants as indicated in the table above, per the AREDS 9-step AMD classification system, with 200 participants in the sample. Because the variance of rod-mediated dark adaptation in AMD patients increases with increasing disease severity, the investigators will implement a larger sample size for intermediate AMD and a smaller sample for patients in normal macular health.
The investigators will collect demographic characteristics (age, race/ethnicity, gender), ocular medical history from the electronic health record, and medication use. In addition, the protocol will focus on measuring the following major components:
Statistical associations will be computed using correlational analysis for the overall sample, within each patient group, and also separately for those with SDD. Sample size estimation is challenging because there is no previous literature on the association between rod-mediated dark adaptation and MNREAD reading performance or MOST performance. With a sample size of 200 participants, the investigators will have adequate statistical power (80%) to detect a correlation of at least 0.20 for the total sample and adequate statistical power to detect within-group correlations of at least 0.40.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Streetlab VR is a virtual reality headset that is warn to simulate walking through a maze at different light levels.
Time frame: Approximately 2 years
Total EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness = 0 μm.
Time frame: Approximately 2 years
Partial EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness ≤ 20 μm.
Time frame: Single visit, approximately 5-6 hours
Measured for right and left eyes separately using the AdaptDx, a computerized dark adaptometer.
Time frame: Single visit, approximately 5-6 hours
Reading performance will be assessed binocularly with the MNREAD iPad app on a digital version of the MNREAD chart. The MNREAD is a text based chart used to measure near visual acuity in people with normal or low vision.
Time frame: Single visit, approximately 5-6 hours
The MOST task involves walking through a maze which can be performed under a range of mesopic and photopic conditions. Scoring is automatically computed based on the duration and mobility errors, which generated a score from 0 to 100, with 100 as the best performance.
Contact information is provided by the study sponsor or research team.
Alice Ventura
CONTACT
Eleonora Lad, MD, PhD
CONTACT
Duke University
Other
AMD and Validating Rod-Meditated Dark Adaptation With Everyday Task Performance
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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