3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neuritis (FLACON) (FLACON)

March 11, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild

3D FLAIR Versus Coronal T2-WI MRI in Detecting Optic Neuritis in Patients Presenting With Acute Visual Loss and Otherwise Normal Ophthalmological Examination

3D FLAIR, 3D T1 FAT SAT, coronal T2 and coronal T1 dixon sequences were usually used to assess visual deficits in MRI. Optic nerve examination is preferably performed using a coronal T2 sequence in order to detect a hypersignal suggestive of inflammation whereas brain examination is preferably performed using a 3D FLAIR sequence to highlight signs of spatial dissemination and lesions suggestive of multiple slerosis (MS).

Recently, a study based on a small number of patients showed the interest of 3D FLAIR in the detection of the hypersignal of the optic nerve.The objective of this retrospective study is to determine whether a single 3D FLAIR sequence allows simultaneous exploration of the optic nerve and the brain for the positive diagnosis of optic neuropathy and/or MS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75019
        • Hopital Fondation Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting with acute visual loss and explored by MRI

Description

Inclusion Criteria:

  • Age > 18 years
  • Decrease in visual acuity explored in MRI between january 2018 and january 2020

Exclusion Criteria:

  • Past history of episode of Optic neuritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of optic neuropathies using MRI
Time Frame: 1 hour
MRI comparison of the diagnostic performance of the 3D FLAIR sequence and the T2 coronal in the detection of optic neuropathies.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (ACTUAL)

March 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE_20200204_1_ALR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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