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

NCT07425106 | Enrolling By Invitation FDA Device

• 2 other identifiers: Pro00111488_1R01AG072732
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Optical Coherence Tomography of Retina; Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device

  measured by: ability to see clearly defined and recognizable structures of the retina with the low-cost OCT device.

  during study procedures (30 minutes)

• RNFL Thickness

  Thickness of retinal nerve fiber layer, measured in microns

  during study procedures (30 minutes)

• GCL Thickness

  Thickness of ganglion cell layer, measured in microns.

  during study procedures (30 minutes)

Secondary Outcomes (1)

• Contrast-to-Noise Ratio (CNR)

  during study procedures (30 minutes)

Study Arms (2)

Performance Testing of OCT-a/LCI (1B)

EXPERIMENTAL

Performance testing of custom OCT-a/LCI device.

Device: retinal imaging with low-cost OCT-a/LCI device

Retinal Morphology (2/3)

EXPERIMENTAL

examination with OCT-a/LCI device to examine retinal morphology characteristics of participants with Alzheimer's disease and healthy controls

Device: retinal imaging with low-cost OCT-a/LCI device

Interventions

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

retinal imaging with low-cost OCT-a/LCI device

Performance Testing of OCT-a/LCI (1B); Retinal Morphology (2/3)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to provide informed consent

You may not qualify if:

• potentially confounding ocular conditions, such as: glaucoma, current corneal injury, retinal damage, diabetes, corrected distance visual acuity worse than 20/40
• eyes that have had intraocular surgery or retinal surgery, other than cataract surgery
• Participants with Alzheimer's Disease:
• \- mild cognitive impairment (MCI) or dementia due to Alzheimer's disease, confirmed by A/T/N classification
• Healthy Controls:
• \- has a memory or other neurodegenerative diagnosis (including mild cognitive impairment, Parkinson's disease, Alzheimer's disease, traumatic brain injury, post-traumatic stress disorder)

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Adam Wax, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)