Comparative Study of High Performance Low-Cost Optical Coherence Tomography

Not Applicable

Completed

• Conditions: Optical Coherence Tomography of Retina
• Interventions: Device: retinal imaging with low-cost OCT device; Device: retinal imaging with commercial OCT device

• Registration Number: NCT05530460
• Lead Sponsor: Duke University

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.

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.

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-07
• Study Start: 2024-03-22
• Primary Completion: 2024-05-17
• Study Completion: 2024-05-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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, other than cataract surgery

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCT Imaging	retinal imaging with low-cost OCT device	-
OCT Imaging	retinal imaging with commercial OCT device	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device	during study procedures (30 minutes)	measured by: ability to see clearly defined and recognizable structures of the retina with the low-cost OCT device.

Secondary Outcome Measures

Name	Time	Method
Contrast-to-Noise Ratio (CNR)	during study procedures (30 minutes)	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States