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

Comparative Study of High Performance Low-Cost Optical Coherence Tomography

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alzheimer Disease; Optical Coherence Tomography of Retina
• Intervention / Treatment: Device: retinal imaging with low-cost OCT-a/LCI device

Detailed Description

There is some evidence that certain changes in retinal structures could be an indicator of Alzheimer's disease (AD). We are developing a new technology that combines optical coherence tomography (OCT) and angle-resolved low coherence interferometry (a/LCI) to make light scattering measurements of retinal tissue structure. The first objective of this study is to compare performance characteristics of our custom OCT instrument to a commercial OCT instrument. Once we have optimized our device, the second objective will be to use the custom OCT-a/LCI device to identify retinal structure changes that could be possible AD biomarkers.

For this study, the team will recruit volunteers to attend one study visit that is about 30 minutes long. For arm 1A (registered under NCT05530460), this visit will include examination with our custom OCT instrument, followed by examination with a commercial OCT system. For arms 1B and 2/3, the visit will include examination with the custom OCT-a/LCI instrument.

This study will recruit participants with Alzheimer's disease and healthy controls.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

All Participants:

Inclusion Criteria:

• able to provide informed consent

Exclusion Criteria:

• 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:

Inclusion:

- mild cognitive impairment (MCI) or dementia due to Alzheimer's disease, confirmed by A/T/N classification

Healthy Controls:

Exclusion:

- has a memory or other neurodegenerative diagnosis (including mild cognitive impairment, Parkinson's disease, Alzheimer's disease, traumatic brain injury, post-traumatic stress disorder)

If two eyes satisfy the inclusion / exclusion criteria, both eyes will be included in the study. If only one eye satisfies the criteria, only the qualifying eye will be included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Performance Testing of OCT-a/LCI (1B); Performance testing of custom OCT-a/LCI device.	Device: retinal imaging with low-cost OCT-a/LCI device; retinal imaging with low-cost 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	Device: retinal imaging with low-cost OCT-a/LCI device; retinal imaging with low-cost OCT-a/LCI device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast-to-Noise Ratio (CNR)	Measure of OCT image quality comparing level of image contrast to level of background noise. CNR = (mean of signal of region of interest [i.e., retina] - mean of background noise) divided by square root of (the square of the standard deviation of the region of interest + the square of the standard deviation of the background noise). Therefore, CNR is unitless.	during study procedures (30 minutes)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Adam Wax, Ph.D., Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: Pro00111488_1; R01AG072732 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No