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NCT02485054 Clinical Trial

A Predictive Score for the Ischemic Etiology of a Transient Visual Disturbances (VASCO)

Vision Disorders Clinical Trial

— VASCO  

Official title:
Development and Validation of a Predictive Score for the Ischemic Etiology of a Transient Visual Disturbances

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02485054
Other study ID # MOA_2014-32
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date October 2018

Study information
Verified date March 2019
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The transient visual disturbances (TVD) are defined by a short abnormality of visual function. Their etiology may be ophthalmological, neurological non-ischemic or of ischemic origin.

The difficulty is to recognize an ischemic mechanism which imposes emergency cares.

A clinical score could help the clinician to recognize the etiology of the TVD .

Recruitment information / eligibility
Status Completed
Enrollment 403
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Transient visual disturbances (i.e. less than 24 hours) during the last 8 days

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Clinical, ophthalmological and neurological evaluation
Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography

Locations
Country Name City State
France Fondation ophtalmologique Adolphe de Rothschild Paris
France Hôpital Bichat 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 Etiology, ischemic or not, of the initial transient visual disturbance Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months. 3 months
Secondary Incidence of new visual transient ischemic attacks during the 3 months of follow-up Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months. 3 months
Secondary Incidence of visual ischemic strokes during the 3 months of follow-up Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months. 3 months
Secondary Incidence of transient ischemic attacks, visual or not visual, during the 3 months of follow-up Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months. 3 months
Secondary Incidence of ischemic strokes, visual or not visual, during the 3 months of follow-up Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography and a new evaluation after 3 months. 3 months
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