Skip to main content
Clinical Trials/NCT04326842
NCT04326842
Completed
Not Applicable

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

First Affiliated Hospital of Harbin Medical University1 site in 1 country129 target enrollmentApril 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carotid Stenosis
Sponsor
First Affiliated Hospital of Harbin Medical University
Enrollment
129
Locations
1
Primary Endpoint
Superficial Vascular Complexes Vessel Density
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2, 2020
End Date
July 2, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Harbin Medical University
Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Superficial Vascular Complexes Vessel Density

Time Frame: Difference of vessel density in each group at baseline

superficial vascular complexes vessel density of Optical Coherence Tomography Angiography

Choriocapillaris Vessel Density

Time Frame: Difference of vessel density in each group at baseline

choriocapillaris vessel density of Optical Coherence Tomography Angiography

Radical Peripapillary Capillaries Vessel Density

Time Frame: 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

Time Frame: Difference of vessel density in each group at baseline

deep vascular complexes vessel density of Optical Coherence Tomography Angiography

Secondary Outcomes

  • Changes of Superficial Vascular Complexes Vessel Density(baseline and 4 days after carotid artery procedure)
  • Changes of Retinal Nerve Fiber Layer(baseline and 4 days after carotid artery procedure)
  • Changes of Deep Vascular Complexes Vessel Density(baseline and 4 days after carotid artery procedure)
  • Change of Difference of Mean Transit Time(dMTT)(baseline and 4 days after carotid artery procedure)
  • Change of the Ratio of Cerebral Blood Flow(rCBF)(baseline and 4 days after carotid artery procedure)
  • Changes of Radical Peripapillary Capillaries Vessel Density(baseline and 4 days after carotid artery procedure)

Study Sites (1)

Loading locations...

Similar Trials