Imagery of Retinal and Choroidal Variations Observed After a Revascularization Procedure on the Internal Carotid Artery (CAROCT-A)
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|ClinicalTrials.gov Identifier: NCT03939351|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment|
|Carotid Artery Injuries||Diagnostic Test: OCT-angiography and SD-OCT|
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|
|Estimated Enrollment :||30 participants|
|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|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2021|
- Diagnostic Test: OCT-angiography and SD-OCT
Performing an OCT-angiography and SD-OCT examination
- 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
- Vascular density of contralateral eye (%) [ Time Frame: 1 month ]Describe the variations of vascular density in OCT-A on the controlateral eye after revascularization
- Subfoveal choroidal thickness [ Time Frame: 1 month ]Describe the variations of subfoveal choroidal thickness in OCT-EDI (Enhanced depth imaging optical coherence tomography) after revascularization
- Optical fiber thickness [ Time Frame: 1 month ]Describe the variations in homolateral optical fiber thickness in RNFL ( Retinal Nerve Fiber Layer)OCT after revascularization
- retinal and choroidal vascular density (%) [ Time Frame: 1 month ]Compare the retinal and choroidal variations according to the proposed procedure: conventional surgery or angioplasty and stenting
- Intraocular pressure (mm Hg) [ Time Frame: 1 month ]Compare changes in intraocular pressure before and after revascularization procedure
- Retinal and choroidal vascular density (%) according to the type of carotid stenosis [ Time Frame: 1 month ]Compare changes in retinal and choroidal vascular density according to the type of carotid stenosis: symptomatic stenosis, asymptomatic stenosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939351
|Contact: Camille JUNG, MDfirstname.lastname@example.org|
|Créteil, France, 94000|