NCT05530460

Comparative Study of High Performance Low-Cost Optical Coherence Tomography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• 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.

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 objective of this device feasibility study is to compare performance characteristics of our custom OCT instrument to a commercial OCT instrument. Once we have optimized our device, we may use it in future studies to identify retinal structure changes that could be possible AD biomarkers. For this study, the team will recruit healthy volunteers to attend one study visit that is about 30 minutes long. This visit will include examination with our custom OCT instrument, followed by examination with a commercial OCT system.

Conditions

• Optical Coherence Tomography of Retina

Interventions

Type	Name	Description
DEVICE	retinal imaging with low-cost OCT device	Retinal imaging with low-cost OCT device
DEVICE	retinal imaging with commercial OCT device	retinal imaging with commercial OCT device

Timeline

• Start date: 2024-03-22
• Primary completion: 2024-05-17
• Completion: 2024-05-17
• First posted: 2022-09-07
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study