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

Diplopia Clinical Trial

— VASCO-DIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02576925
• Other study ID #: MOA_2015-7
• Status: Recruiting
• Start date: September 24, 2015
• Est. completion date: December 23, 2025

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Michel Rosenheim, MD, DSc
• Phone: +33148036457
• Email: mrosenheim[@]fo-rothschild.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 23, 2025
• Est. primary completion date: September 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Diplopia

Intervention

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

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris	Ile De France
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 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	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
Secondary	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
Secondary	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
Secondary	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