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

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.

Study Overview

• Status: Completed
• Conditions: Carotid Stenosis
• Intervention / Treatment: Procedure: Carotid artery revascularization procedure; Device: Optical coherence tomography angiography

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.

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The First Affiliated Hospital Of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with carotid artery stenosis undergoing cerebral and eye examination and in routine clinical practice will be included

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carotid artery stenosis; Patients with carotid artery stenosis. Procedure: Carotid artery revascularization procedure	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.
Control; Patients without carotid artery stenosis	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Difference of Mean Transit Time(dMTT)	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.	baseline and 4 days after carotid artery procedure
Change of the Ratio of Cerebral Blood Flow(rCBF)	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.	baseline and 4 days after carotid artery procedure
Changes of Retinal Nerve Fiber Layer	changes of retinal nerve fiber layer of Optical Coherence Tomography Angiography	baseline and 4 days after carotid artery procedure
Changes of Deep Vascular Complexes Vessel Density	changes of deep vascular complexes vessel density of Optical Coherence Tomography Angiography	baseline and 4 days after carotid artery procedure
Changes of Radical Peripapillary Capillaries Vessel Density	changes of radical peripapillary capillaries vessel density of Optical Coherence Tomography Angiography	baseline and 4 days after carotid artery procedure
Changes of Superficial Vascular Complexes Vessel Density	changes of superficial vascular complexes vessel density of Optical Coherence Tomography Angiography	baseline and 4 days after carotid artery procedure

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Harbin Medical University
• Investigators: Principal Investigator: Hong Zhang, First Affiliated Hospital of Harbin Medical University; Principal Investigator: Huaizhang Shi, First Affiliated Hospital of Harbin Medical University

Publications and helpful links

General Publications

• Li X, Zhu S, Zhou S, Zhang Y, Ding Y, Zheng B, Wu P, Shi Y, Zhang H, Shi H. Optical Coherence Tomography Angiography as a Noninvasive Assessment of Cerebral Microcirculatory Disorders Caused by Carotid Artery Stenosis. Dis Markers. 2021 Jul 5;2021:2662031. doi: 10.1155/2021/2662031. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2020
• Primary Completion (Actual): June 20, 2020
• Study Completion (Actual): July 2, 2020

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: OCTA; Carotid Stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: HZHZS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes