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

Completed

Conditions: Carotid Stenosis

Interventions: Procedure: Carotid artery revascularization procedure
Device: Optical coherence tomography angiography

Registration Number: NCT04326842

Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 129

Inclusion Criteria

Clinical diagnosis of carotid artery stenosis
Age-gender-race-matched controls

Exclusion Criteria

age <18 years
intraocular pressure (IOP) >21 mmHg
VA >logMAR 1.0
spherical equivalent (SE) between >1.00 or < -6.00 D
other serious eye diseases which may affect OCTA results including diabetic retinopathy, hypertensive retinopathy, retinal vascular occlusion, age-related macular degeneration, and uveitis
major intraocular surgery performed in the past 6 months or a history of laser photocoagulation or intravitreal injection
glaucoma or first-degree relatives with a history of glaucoma; and
any disease that might cause poor scan quality (image quality <6).

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid artery stenosis	Optical coherence tomography angiography	Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure
Carotid artery stenosis	Carotid artery revascularization procedure	Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure
Control	Optical coherence tomography angiography	Patients without carotid artery stenosis

Primary Outcome Measures

Name	Time	Method
Superficial Vascular Complexes Vessel Density	Difference of vessel density in each group at baseline	superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
Choriocapillaris Vessel Density	Difference of vessel density in each group at baseline	choriocapillaris vessel density of Optical Coherence Tomography Angiography
Radical Peripapillary Capillaries Vessel Density	Difference of vessel density in each group at baseline	Radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography（OCTA）
Deep Vascular Complexes Vessel Density	Difference of vessel density in each group at baseline	deep vascular complexes vessel density of Optical Coherence Tomography Angiography

Secondary Outcome Measures

Name	Time	Method
Changes of Superficial Vascular Complexes Vessel Density	baseline and 4 days after carotid artery procedure	changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography
Changes of Retinal Nerve Fiber Layer	baseline and 4 days after carotid artery procedure	changes of retinal nerve fiber layer of Optical Coherence Tomography Angiography
Changes of Deep Vascular Complexes Vessel Density	baseline and 4 days after carotid artery procedure	changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography
Change of Difference of Mean Transit Time(dMTT)	baseline and 4 days after carotid artery procedure	Change of dMTT is the dMTT value at 4 days after carotid artery procedure minus the value at baseline. dMTT is that the value of the lesion side minus value of contralateral side. Mean transit time (MTT) corresponds to the average time, in seconds, that red blood cells spend within a determinate volume of capillary circulation.
Change of the Ratio of Cerebral Blood Flow(rCBF)	baseline and 4 days after carotid artery procedure	Change of rCBF is the rCBF value at 4 days after carotid artery procedure minus the value at baseline. rCBF is that the CBF value of the lesion side divided by the value of contralateral side. CBF refers to the flow of blood through a certain cross-sectional area of cerebrovascular per unit time.
Changes of Radical Peripapillary Capillaries Vessel Density	baseline and 4 days after carotid artery procedure	changes of radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography