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OpenTrials
Completed

NCT Number: NCT05082402

Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

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.

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Key information

Conditions

Cardiovascular Diseases Retina; Change

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University/Northwestern Medical Group, Department of Ophthalmology

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swept Source Optical Coherence Tomography Angiography

Diagnostic 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.

Primary outcomes

  1. Correlation with and prediction of the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography

    Time frame: 2 hours

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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