Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

Northwestern University50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cardiovascular Diseases Retina; Change

Interventions

Swept Source Optical Coherence Tomography AngiographyDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Northwestern University/Northwestern Medical Group, Department of Ophthalmology

Chicago, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 2 hours

Central Contacts

Arnold Nadel

CONTACT

224-436-3677 arnold.nadel@northwestern.edu

Clinical Research Office

CONTACT

312-503-4849 ophthoresearch@northwestern.edu

Data from ClinicalTrials.gov

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