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

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ClinicalTrials.gov Identifier: NCT02576925
Recruitment Status : Recruiting
First Posted : October 15, 2015
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
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 .


Condition or disease Intervention/treatment
Diplopia Other: Clinical, ophthalmological and neurological evaluation

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of a Predictive Score for the Ischemic Etiology of a Transient Diplopia
Actual Study Start Date : September 2015
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Etiology, ischemic or not, of the initial transient diplopia [ Time Frame: 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 :
  1. Incidence of new transient diplopia ischemic attacks during the 3 months of follow-up [ Time Frame: 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.

  2. Incidence of diplopia ischemic strokes during the 3 months of follow-up [ Time Frame: 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.

  3. Incidence of transient ischemic attacks, visual or not visual, during the 3 months of follow-up [ Time Frame: 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.

  4. Incidence of ischemic strokes, visual or not visual, during the 3 months of follow-up [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576925


Contacts
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Contact: Michel Rosenheim, MD, DSc +33148036457 mrosenheim@fo-rothschild.fr

Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, Ile De France, France, 75019
Contact: Mickaël Obadia, MD    0033148036431    mobadia@fo-rothschild.fr   
Hôpital Bichat Recruiting
Paris, France, 75018
Contact: Pierre AMARENCO, MD         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02576925    
Other Study ID Numbers: MOA_2015-7
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Diplopia
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms