Skip to main content
Clinical Trials/NCT03939351
NCT03939351
Withdrawn
Not Applicable

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

Centre Hospitalier Intercommunal Creteil1 site in 1 countryJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carotid Artery Injuries
Sponsor
Centre Hospitalier Intercommunal Creteil
Locations
1
Primary Endpoint
homolateral retinal and choroidal vascular density (%)
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
June 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

homolateral retinal and choroidal vascular density (%)

Time Frame: 1 month

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

Secondary Outcomes

  • Vascular density of contralateral eye (%)(1 month)
  • Subfoveal choroidal thickness(1 month)
  • Optical fiber thickness(1 month)
  • Intraocular pressure (mm Hg)(1 month)
  • Retinal and choroidal vascular density (%) according to the type of carotid stenosis(1 month)
  • retinal and choroidal vascular density (%)(1 month)

Study Sites (1)

Loading locations...

Similar Trials