NCT02485054

Brief Summary

The transient visual disturbances (TVD) are defined by a short abnormality of visual function. 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 TVD .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

3.1 years

First QC Date

June 18, 2015

Last Update Submit

March 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Etiology, ischemic or not, of the initial transient visual disturbance

    Clinical : 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 visual transient ischemic attacks during the 3 months of follow-up

    3 months

  • Incidence of visual 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 visual disturbance during the last 8 days, except a diplopia

Other: Clinical, ophthalmological and neurological evaluation

Interventions

Clinical : 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

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 visual disturbance during the last 8 days and seen at the fondation ophtalmologique Adolphe de Rothschild

You may qualify if:

  • Transient visual disturbances (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

Location

Fondation ophtalmologique Adolphe de Rothschild

Paris, 75020, France

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 30, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations