Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

Study Overview
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Brief Summary
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This study aims to determine whether changes in retinal vasculature seen on SS-OCTA can be correlated to degree of cardiovascular disease as measured by carotid duplex ultrasonography.

Detailed Description
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The study's primary objective is to determine whether measures taken from SS-OCTA, color fundus photography, and retinal exams can correlate with and predict the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography by examining the following parameters: retinal vessel caliber, retinal vessel density, retinal vessel perfusion, retinal vessel tortuosity, presence of Hollenhorst or other plaques, and/or areas of ischemia.

Official Title
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Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

Conditions
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Cardiovascular Diseases, Retina; Change

Intervention / Treatment
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* Diagnostic Test: Swept Source Optical Coherence Tomography Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between 18 and 80 years of age. No known prior history of retinal disease. Able to participate in a clinical eye examination setting. Able to consent. Subjects receiving standard of care carotid duplex ultrasounds. Exclusion Criteria: Known ophthalmologic disease (e.g. glaucoma, macular degeneration, ocular injury) other than corrected refractive error. Lack of capacity to provide informed consent. Subjects younger than 18 years of age or older than 80 years of age. History of stroke or acute loss of vision. Unable to participate in a clinical eye examination setting.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants<br>50 participants identified in the Northwestern Medicine Division of Vascular Surgery. | Diagnostic Test: Swept Source Optical Coherence Tomography Angiography<br>* The PLEX Elite 9000 is an FDA cleared research device for use in ocular imaging obtained by Northwestern University by way of a purchase agreement with the manufacturer, Carl Zeiss Meditec, Inc. It is currently unavailable outside of participation in the ARI Network, a cloudbased storage and image processing platform using deidentified information shared between academic institutions. The ARI Network is managed by a group of physicians and scientists from around the world that are working to better understand eye diseases.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with and prediction of the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography | Determining whether measures taken from SS-OCTA, color fundus photography, and retinal exams can correlate with and predict the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography by examining the following parameters: retinal vessel caliber, retinal vessel density, retinal vessel perfusion, retinal vessel tortuosity, presence of Hellenhorst or other plaques, and/or areas of ischemia. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal vasculature, cardiovascular disease, swept source optical coherence tomography angiography, SS-OCTA, carotid duplex ultrasonography