AMD and Validation Rod-Meditated Dark Adaptation With Everyday Task Performance
ConditionAge-Related Macular Degeneration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-89
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Streetlab VR
Diagnostic testStreetlab VR is a virtual reality headset that is warn to simulate walking through a maze at different light levels.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Early AMDOther 1 intervention
Group B: Intermediate AMDOther 1 intervention
Group C: Geographic AtrophyOther 1 intervention
Group D: AMD ControlsOther 1 intervention
Trial outcomes
Primary outcomes
1
Total number of participants with total ellipsoid zone (EZ) band attenuation
Total EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness = 0 μm.
Time frame
Approximately 2 yearsSecondary outcomes
1
Total number of participants with partial ellipsoid zone (EZ) band attenuation
Partial EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness ≤ 20 μm.
Time frame
Approximately 2 years2
Rod-mediated dark adaptation
Measured for right and left eyes separately using the AdaptDx, a computerized dark adaptometer.
Time frame
Single visit, approximately 5-6 hours3
Reading performance as measured by the MNREAD (Minnesota low vision reading) chart
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 hours4
Mobility as measured by the Mobility Standardized Test (MOST)
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.
Time frame
Single visit, approximately 5-6 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov