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

Recruiting

• Conditions: Diplopia
• Interventions: Other: Clinical, ophthalmological and neurological evaluation

• Registration Number: NCT02576925
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-24
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07
• Primary Completion: 2025-09-23
• Study Completion: 2025-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Transient diplopia (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 diplopia during the last 8 days.

Primary Outcome Measures

Name	Time	Method
Etiology, ischemic or not, of the initial transient diplopia	3 months	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 diplopia ischemic strokes during the 3 months of follow-up	3 months	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	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 new transient diplopia ischemic attacks during the 3 months of follow-up	3 months	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	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, Ile De France, France

Hôpital Bichat; 🇫🇷 Paris, France