Study Stopped
withdrawal of the project
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
2 other identifiers
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Jun 2019
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJanuary 4, 2022
December 1, 2021
1 year
May 3, 2019
December 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Vascular density of contralateral eye (%)
1 month
Subfoveal choroidal thickness
1 month
Optical fiber thickness
1 month
retinal and choroidal vascular density (%)
1 month
Intraocular pressure (mm Hg)
1 month
- +1 more secondary outcomes
Interventions
Performing an OCT-angiography and SD-OCT examination
Eligibility Criteria
The study will be proposed to patients for whom revascularization has been performed by vascular surgeons (symptomatic, asymptomatic carotid stenosis)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Henri-Mondor
Créteil, 94000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 6, 2019
Study Start
June 1, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2021
Last Updated
January 4, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share