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
• Status: Completed
• 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
• 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:

Related Conditions & MeSH terms

• Vision Disorders

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