A Predictive Score for the Ischemic Etiology of a Transient Diplopia (VASCO-DIP) (VASCO-DIP)

Development and Validation of a Predictive Score for the Ischemic Etiology of a Transient Diplopia

The transient diplopias (TD) is defined by a short diplopia. 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 TD .

Study Overview

• Status: Recruiting
• Conditions: Diplopia
• Intervention / Treatment: Other: Clinical, ophthalmological and neurological evaluation

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Michel Rosenheim, MD, DSc; Phone Number: +33148036457; Email: mrosenheim@fo-rothschild.fr

Study Locations

• France
  • Paris, France, 75018
    • Recruiting
    • Hôpital Bichat
    • Contact: Pierre AMARENCO, MD
  • Ile De France
    • Paris, Ile De France, France, 75019
      • Recruiting
      • Fondation Ophtalmologique Adolphe de Rothschild
      • Contact: Mickaël Obadia, MD; Phone Number: 0033148036431; Email: mobadia@fo-rothschild.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults having had a transient diplopia during the last 8 days and seen at the fondation ophtalmologique Adolphe de Rothschild

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Eligible patients; Adults having had a transient diplopia during the last 8 days.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Etiology, ischemic or not, of the initial transient diplopia	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of new transient diplopia ischemic attacks during the 3 months of follow-up	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
Incidence of diplopia ischemic strokes during the 3 months of follow-up	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
Incidence of transient ischemic attacks, visual or not visual, during the 3 months of follow-up	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
Incidence of ischemic strokes, visual or not visual, during the 3 months of follow-up	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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2015
• Primary Completion (Estimated): September 23, 2025
• Study Completion (Estimated): December 23, 2025

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimated): October 15, 2015

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Diplopia
• Other Study ID Numbers: MOA_2015-7