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

Completed

• Conditions: Vision Disorders
• Interventions: Other: Clinical, ophthalmological and neurological evaluation

• Registration Number: NCT02485054
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-30
• Study Start: 2015-09
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eligible patients	Clinical, ophthalmological and neurological evaluation	Adults having had a transient visual disturbance during the last 8 days, except a diplopia

Primary Outcome Measures

Name	Time	Method
Etiology, ischemic or not, of the initial transient visual disturbance	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of new visual transient ischemic attacks during the 3 months of follow-up	3 months	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.
Incidence of transient ischemic attacks, visual or not visual, during the 3 months of follow-up	3 months	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.
Incidence of visual ischemic strokes during the 3 months of follow-up	3 months	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.
Incidence of ischemic strokes, visual or not visual, during the 3 months of follow-up	3 months	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.

Trial Locations

Locations (2)

Fondation ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France

Hôpital Bichat; 🇫🇷 Paris, France