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NCT03964610 Clinical Trial

Multimodal Retinal Imaging of Cerebrovascular Stroke

Stroke Clinical Trial

— OCTAV  

Official title:
Multimodal Retinal Imaging of Cerebrovascular Stroke

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03964610
Other study ID # RHE_2019_10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2019
Est. completion date February 15, 2022

Study information
Verified date March 2022
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The hypothesis is that in patients with stroke, abnormalities of retinal microvascularization shown on color fundus photography and the depletion of retinal capillary density evaluated by OCT-A are markers of acute impairment of microcirculation of the central nervous system and are correlated with lesions on brain imaging. Patients hospitalized for stroke MRI-confirmed, will be included. An ophthalmologic assessment including color fundus photography (CFP) and OCT-A will be carried out after stabilization and at 3 months follow-up. Outcomes assessor will be blinded.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date February 15, 2022
Est. primary completion date November 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Acute ischemic stroke - With cerebral microangiopathy (defined by a SVD score > 1) Exclusion criteria: - Acute hemorrhagic stroke - Anophthalmia

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• color fundus photography (CFP) and OCT-A
Included patients will have an ophthalmologic assessment (OCT-A and CPF) after stabilization and at 3 months follow-up.

Locations
Country Name City State
France Fondation A de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of an anomaly in color fundus photography or an anomaly of retinal capillary density to OCT-A 3 months
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