Clinical trial NCT03939351: Imagery of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carotid Artery Injuries
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: homolateral retinal and choroidal vascular density (%)
timeFrame: 1 month
Secondary outcomes:
measure: Vascular density of contralateral eye (%)
timeFrame: 1 month
measure: Subfoveal choroidal thickness
timeFrame: 1 month
measure: Optical fiber thickness
timeFrame: 1 month
measure: retinal and choroidal vascular density (%)
timeFrame: 1 month
measure: Intraocular pressure (mm Hg)
timeFrame: 1 month
measure: Retinal and choroidal vascular density (%) according to the type of carotid stenosis
timeFrame: 1 month
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHU Henri-Mondor
Study officials:
References: