Comparative Study of High Performance Low-Cost Optical Coherence Tomography

Duke University11 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Optical Coherence Tomography of Retina

Interventions

retinal imaging with low-cost OCT deviceDEVICE

Retinal imaging with low-cost OCT device

retinal imaging with commercial OCT deviceDEVICE

retinal imaging with commercial OCT device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: during study procedures (30 minutes)

Secondary Outcomes

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.

Time frame: during study procedures (30 minutes)

Data from ClinicalTrials.gov

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