Low-Cost OCT Device for Retinal Imaging

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, affordable device for capturing images of the retina at the back of the eye. The goal is to determine if the Low-Cost OCT-a/LCI Device can produce images as clear as those from more expensive machines and accurately measure retina structures. Individuals with Alzheimer's or those who are healthy and have no major eye issues, such as glaucoma or past eye surgeries (except cataract surgery), may be suitable candidates. Participants should not have diabetes or severe vision problems worse than 20/40. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could make eye imaging more accessible.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this OCT device is safe for retinal imaging?

Research has shown that affordable optical coherence tomography (OCT) devices hold promise for safe and non-invasive eye scans. One study tested a new OCT scanner and found it produced images 95% as clear as those from current commercial devices, indicating the new device works effectively without causing harm.

The development of these devices aims to make eye care more accessible by reducing costs and simplifying use. Studies with these low-cost OCT devices have reported no negative effects, suggesting they are well-tolerated by patients.

Since OCT is already widely used in eye care and considered safe, the new, cheaper version should also be safe for most people.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a low-cost OCT device for retinal imaging, which could make it easier and more affordable to examine retinal changes, especially for people with Alzheimer's disease. Unlike traditional retinal imaging methods, which can be expensive and less accessible, this device aims to provide detailed insights into retinal morphology at a fraction of the cost. The device's advanced imaging technology, specifically the OCT-a/LCI, offers a new way to potentially detect early signs of Alzheimer’s through the eyes, providing a non-invasive and innovative approach to diagnosis and monitoring.

What evidence suggests that this OCT-a/LCI device is effective for retinal imaging?

Research has shown that examining the retina, the back part of the eye, can help detect Alzheimer's disease. A special scan called optical coherence tomography (OCT) captures detailed images of the retina, revealing changes linked to Alzheimer's. Studies have found that certain patterns in these images can identify early Alzheimer's with high accuracy. For example, one study found that OCT images could correctly classify Alzheimer's over 98% of the time. This trial will test a low-cost OCT device for retinal imaging, which could effectively spot early signs of Alzheimer's through retinal changes, making it a promising and accessible screening tool.13678

Who Is on the Research Team?

AW

Adam Wax, Ph.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for people who can give informed consent, including those with Alzheimer's disease. There are no other specific requirements or exclusions listed.

Inclusion Criteria

* able to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Study Visit

Participants attend a single study visit for examination with the custom OCT-a/LCI device and a commercial OCT system

30 minutes
1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions or data analysis post-study visit

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Retinal Imaging with Low-Cost OCT-a/LCI Device

Trial Overview

The study is testing a new, affordable eye imaging device (OCT-a/LCI) to see if it can take retinal images as well as standard commercial devices. The device will also measure the structure of retinal tissue.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Retinal Morphology (2/3)Experimental Treatment1 Intervention
Group II: Performance Testing of OCT-a/LCI (1B)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

Non-Invasive Retinal Biomarkers for Early Diagnosis of ... - PMC

OCT, OCTA, and scanning laser ophthalmoscopy (SLO) represent promising tools for early AD diagnosis and assessing the risk of disease ...

Early detection of dementia through retinal imaging and ...

We propose a novel deep learning framework, Eye-AD, to detect Early-onset Alzheimer's Disease (EOAD) and Mild Cognitive Impairment (MCI) using OCTA images.

Alzheimer's Disease Classification using Retinal OCT

The best classification architecture is TransNetOCT, which has an average accuracy of 98.18% for input OCT images and 98.91% for segmented OCT ...

Low-Cost OCT Device for Retinal Imaging

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 ...

Comparative Study of High Performance Low-Cost Optical ...

There is some evidence that certain changes in retinal structures could be an indicator of Alzheimer's disease (AD).

Development of next generation low-cost OCT towards ... - PMC

Low-cost optical coherence tomography (OCT) has shown promise in increasing access to noninvasive retinal imaging at the point of care, especially in ...

A review of low-cost and portable optical coherence ...

In this paper, we review the current development and applications of low-cost, portable and handheld OCT in both translational and research settings.

High-Performance, Low-Cost Optical Coherence Tomography ...

We report on the development of a compact, low-cost OCT system that offers significantly improved performance while also further reducing cost and system size.