Imagery of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery (CAROCT-A)

Multimodal Imaging Analysis, OCT-angiography (Optical Coherence Tomography) and SD-OCT (Spectral Domain Optical Coherence Tomography), of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery

The purpose of this study is to describe the changes in morphology and Retinal vascularization after revascularization of the internal carotid artery. Indeed, the stenosis of the internal carotid artery can lead to ophthalmological charts. The underlying hypothesis is that revascularization of the internal carotid artery would improve ipsilateral and retinal homolateral perfusion in the short term. The OCT-angiography technique accurately studies the retinal vasculature and also assesses the risk of retinal and choroidal embolism, which is recognized as increased in cases of symptomatic or asymptomatic carotid stenosis.

Study Overview

• Status: Withdrawn
• Conditions: Carotid Artery Injuries
• Intervention / Treatment: Diagnostic test: OCT-angiography and SD-OCT

Detailed Description

The stenosis of the internal carotid artery is a frequent and potentially serious pathology (TIA, ischemic stroke, death), which can also be manifested by ophthalmological charts, foremost among which are transient monocular blindness.

The most common etiology of this stenosis remains the atheromatous pathology, whose treatment, depending on the symptomatic or non-symptomatic nature of the stenosis, includes, among other things, a revascularization procedure that may be surgical (endarterectomy, reference treatment) or guided by radiology (angioplasty and carotid stent placement)

From the anatomical point of view, the internal carotid artery notably has for branching the ophthalmological artery, which itself will give birth:

• at the central artery of the retina: role in the vascularization of the inner layers of the retina
• posterior ciliary arteries: role in the choroidal vasculature and outer layers of the retina.

Very little knowledge at the present time relates changes in retinal and choroidal vascularization after a revascularization procedure on the internal carotid artery OCT-angiography is a non-invasive imaging technique that is now part of investigative examinations in retinal imaging. This technique makes it possible to study the macular and choroidal retinal vascularization with precision without injection of contrast medium and thus allows to deepen the knowledge in medical fields where the exploration was until now limited because of the invasiveness of the examinations.

The hypothesis of this project is that revascularization of the internal carotid artery would improve retinal and choroidal ipsilateral perfusion in the short term (1 month postoperatively), as assessed by OCT-angiography. OCT-angiography could also be used to assess retinal and choroidal embolism risk, usually recognized as increased in cases of symptomatic or asymptomatic carotid stenosis.

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • CHU Henri-Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will be proposed to patients for whom revascularization has been performed by vascular surgeons (symptomatic, asymptomatic carotid stenosis)

Description

Inclusion Criteria

• Patient aged 18 or over
• Indication of treatment with a carotid revascularization procedure (conventional surgery or angioplasty and stent)
• Acceptance to participate in the protocol

Exclusion Criteria:

• Associated retinal ophthalmological pathology: diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, CRSC (Central serous chorioretinopathy)
• Refusal to participate in the study
• Not affiliated to a social security scheme

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
homolateral retinal and choroidal vascular density (%)	Finely describe the homolateral retinal and choroidal vascular density changes in the macula in OCT-angiography at 1 month after revascularization on the internal carotid artery	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular density of contralateral eye (%)	Describe the variations of vascular density in OCT-A on the controlateral eye after revascularization	1 month
Subfoveal choroidal thickness	Describe the variations of subfoveal choroidal thickness in OCT-EDI (Enhanced depth imaging optical coherence tomography) after revascularization	1 month
Optical fiber thickness	Describe the variations in homolateral optical fiber thickness in RNFL ( Retinal Nerve Fiber Layer)OCT after revascularization	1 month
retinal and choroidal vascular density (%)	Compare the retinal and choroidal variations according to the proposed procedure: conventional surgery or angioplasty and stenting	1 month
Intraocular pressure (mm Hg)	Compare changes in intraocular pressure before and after revascularization procedure	1 month
Retinal and choroidal vascular density (%) according to the type of carotid stenosis	Compare changes in retinal and choroidal vascular density according to the type of carotid stenosis: symptomatic stenosis, asymptomatic stenosis	1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Carotid Artery Diseases; Cerebrovascular Trauma; Carotid Artery Injuries
• Other Study ID Numbers: CAROCT-A; 2018-A00777-48 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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