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

H

Harbin Medical University

Status

Completed

Conditions

Carotid Stenosis

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

129 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

129 participants in 2 patient groups

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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