Comparative Study of High Performance Low-Cost Optical Coherence Tomography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-22

Study Completion Date

2024-05-17

Brief Summary

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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.

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Detailed Description

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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

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Optical Coherence Tomography of Retina

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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OCT Imaging

Group Type EXPERIMENTAL

retinal imaging with low-cost OCT device

Intervention Type DEVICE

Retinal imaging with low-cost OCT device

retinal imaging with commercial OCT device

Intervention Type DEVICE

retinal imaging with commercial OCT device

Interventions

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retinal imaging with low-cost OCT device

Retinal imaging with low-cost OCT device

Intervention Type DEVICE

retinal imaging with commercial OCT device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes