NCT07425106

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Optical Coherence Tomography of Retina
• Alzheimer Disease

Interventions

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

Timeline

• Start date: 2026-02-13
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2026-02-20
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study