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Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05082402
Enrollment
42
Registered
2021-10-19
Start date
2021-08-17
Completion date
2023-10-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Retina; Change

Keywords

retinal vasculature, cardiovascular disease, swept source optical coherence tomography angiography, SS-OCTA, carotid duplex ultrasonography

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.

Interventions

DIAGNOSTIC_TESTSwept Source Optical Coherence Tomography Angiography

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.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

Inclusion criteria

* Subjects between 18 and 95 years of age * Able to participate in a clinical eye examination setting * Able to consent * Subjects receiving standard of care carotid duplex ultrasounds

Exclusion criteria

* Inability to get high quality imaging for any reason (ex. Dense cataract, media opacity) * Lack of capacity to provide informed consent * Subjects younger than 18 years of age or older than 95 years of age * History of stroke or acute loss of vision * Unable to participate in a clinical eye examination setting

Design outcomes

Primary

MeasureTime frameDescription
Correlation with and prediction of the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography2 hoursDetermining 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRukhsana Mirza, MD

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026