Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging

Study Overview
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Brief Summary
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This is a clinical pilot study to assess the feasibility of using a swept-source optical coherence tomography (SSOCT) system to perform noninvasive imaging of the retinal vasculature in patients with existing microvascular disease.

Detailed Description
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This project is being conducted under an abbreviated IDE. Subjects with existing retinal microvascular disease will be recruited from among the patients of the Duke Eye Center and/or its associated satellite clinics. Following informed consent, subjects undergo imaging, per established standard operating procedure, at the Duke University Medical Center/Duke Center or at one of the Duke Eye Center satellite clinics. Pharmacologic dilation of eyes will not be necessary for completion of imaging and will not be used for the purposes of this study. The resulting images will not be used in the clinical care of any of the subjects recruited for this project. Subjects will be identified from patients presenting for ophthalmologic consultation at the Duke Eye Center and/or its satellite clinic locations.

Official Title
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Swept-Source Optical Coherence Tomography for Noninvasive Retinal Vascular Imaging

Conditions
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Retinal Vascular Disease

Intervention / Treatment
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* Device: Swept-Source Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable and willing to provide consent history of clinically-diagnosed retinal microvascular diseases, including but not limited to diabetic retinopathy, retinal vein occlusion, idiopathic macular telangiectasias, hypertensive retinopathy, and age-related macular degeneration At least 18 years of age Exclusion Criteria: Unable or unwilling to give consent Under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Other: retinal vascular occlusion arm<br>Patients with existing retinal microvascular disease will undergo imaging. | Device: Swept-Source Optical Coherence Tomography<br>* Noninvasive imaging of the retinal vasculature in patient with existing microvascular disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT images and metrics derived from the OCT images | Distributions, means, and standard deviations will be reported. | Day of imaging, approximately 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal vascular disease, Swept-Source Ocular Coherence Tomography, SSOCT