NCT02576925

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 .

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

10 years

First QC Date

October 13, 2015

Last Update Submit

June 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Incidence of new transient diplopia ischemic attacks during the 3 months of follow-up

    3 months

  • Incidence of diplopia ischemic strokes during the 3 months of follow-up

    3 months

  • Incidence of transient ischemic attacks, visual or not visual, during the 3 months of follow-up

    3 months

  • Incidence of ischemic strokes, visual or not visual, during the 3 months of follow-up

    3 months

Study Arms (1)

Eligible patients

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

Other: Clinical, ophthalmological and neurological evaluation

Interventions

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

Eligible patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Bichat

Paris, 75018, France

RECRUITING

Fondation Ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

RECRUITING

MeSH Terms

Conditions

Diplopia

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Michel Rosenheim, MD, DSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 15, 2015

Study Start

September 24, 2015

Primary Completion

September 23, 2025

Study Completion

December 23, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations