Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT06619405

Conditions

Age-Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Streetlab VR

Study Details

Brief summary:

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.

Conditions

Age-Related Macular Degeneration

Study ID

NCT06619405

Start date

Aug 15, 2025

Status verified date

Aug, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Early AMD

Study patients who have a diagnosis of early AMD

other: Intermediate AMD

Study patients who have a diagnosis of Intermediate AMD

other: Geographic Atrophy

Study patients who have a diagnosis of Geographic Atrophy

other: AMD Controls

Study patients who have healthy eyes

Interventions

Streetlab VR

Streetlab VR is a virtual reality headset that is warn to simulate walking through a maze at different light levels.

Primary outcome measure

  • Total number of participants with total ellipsoid zone (EZ) band attenuation [ Time Frame: Approximately 2 years ]

Central Contacts and Locations

Central contacts

Eleonora Lad, MD, PhD

919-684-4359nora.lad@duke.edu

Alice Ventura

919-681-6585alice.ventura@duke.edu

Locations

Duke Eye Center

Recruiting

Durham, North Carolina, United States, 27710

More Information

Sponsor

Duke University

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-10.