Comparative Study of High Performance Low-Cost Optical Coherence Tomography

Study Overview
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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.

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.

Official Title
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Comparative Study of High Performance Low-Cost Optical Coherence Tomography

Conditions
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Optical Coherence Tomography of Retina

Intervention / Treatment
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* Device: retinal imaging with low-cost OCT device
* Device: retinal imaging with commercial OCT device


Participation Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT Imaging<br> | Device: retinal imaging with low-cost OCT device<br>* Retinal imaging with low-cost OCT device<br>Device: retinal imaging with commercial OCT device<br>* retinal imaging with commercial OCT device<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast-to-Noise Ratio (CNR) | 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. | during study procedures (30 minutes) |