Comparative Study of High Performance Low-Cost Optical Coherence Tomography (Stage 1B, 2 and 3)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07425106
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • retinal imaging with low-cost OCT-a/LCI device — DEVICE
    retinal imaging with low-cost OCT-a/LCI device

Study Details

The purpose of this study is to complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device. We will then add an angle-resolved low coherence interferometry (a/LCI module) to the device to make measurements of retinal tissue structure.

Key Dates

Start date
Feb 13, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
82 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Performance Testing of OCT-a/LCI (1B)
    Performance testing of custom OCT-a/LCI device.
  • Experimental: Retinal Morphology (2/3)
    examination with OCT-a/LCI device to examine retinal morphology characteristics of participants with Alzheimer's disease and healthy controls

Primary Outcome Measure

Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device [ Time Frame: during study procedures (30 minutes) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

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By research site
Duke University Medical Center· Durham, NC

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