Clinical trial NCT05082402: Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease
Official title: Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Retina; Change
Keywords: retinal vasculature
cardiovascular disease
swept source optical coherence tomography angiography
SS-OCTA
carotid duplex ultrasonography
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation with and prediction of the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University/Northwestern Medical Group, Department of Ophthalmology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Rukhsana Mirza, MD
role: PRINCIPAL_INVESTIGATOR
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