NCT04326842

Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: First Affiliated Hospital of Harbin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.

Detailed description

A growing body of research indicates that abnormal ocular microvascular features may serve as a novel biomarker reflecting the severity of underlying cardiovascular, neurodegenerative, and microvascular disease. Since blood flow to the retina is predominantly supplied by the internal carotid artery (ICA), we hypothesized that ocular microvasculature and structure changes may reflect the disease status or therapeutic effects in patients with carotid artery stenosis. Optical coherence tomography angiography (OCTA) is a novel, non-invasive imaging modality that can be a reliable tool for the qualitative and quantitative assessments of ocular vessels during various ocular pathological or physiological changes. Recent studies have also demonstrated the ability of OCTA to quantify retinal microvascular changes in monitoring cardiovascular risk. This study aims to evaluate ocular changes in patients with carotid artery stenosis by optical coherence tomography angiography before and after carotid artery revascularization procedure.In this study, the patients with carotid artery stenosis and control group will receive a series of cerebral and ocular examinations including the most important cerebral CT perfusion (CTP) and OCTA. After that, the cerebral and ocular data between the two groups will be compared. Also, the preoperative and postoperative data acquired will be compared.

Conditions

• Carotid Stenosis

Interventions

Type	Name	Description
PROCEDURE	Carotid artery revascularization procedure	The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.
DEVICE	Optical coherence tomography angiography	Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps.

Timeline

• Start date: 2020-04-02
• Primary completion: 2020-06-20
• Completion: 2020-07-02
• First posted: 2020-03-30
• Last updated: 2020-10-19
• Results posted: 2020-10-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study