Linking Optic Nerve MRI and the Retinal Axonal Loss After Optic Neuritis (IRMANO)

December 4, 2025 updated by: University Hospital, Lille

Linking Optic Nerve Lesion Length at MRI and the Retinal Axonal Loss at 12 Months From a Clinical Episode of Optic Neuritis

This study evaluates the length of optic nerve lesion on 3D-DIR sequence as an imaging biomarker predictive of retinal axonal loss and visual disability, 12 months after the occurence of a first clinical episode of optic neuritis.

Study Overview

Status

Completed

Conditions

Optic Neuritis

Detailed Description

Neurologists and Neuro-Ophthalmologists are in need for reliable and robust imaging biomarkers enabling to predict retinal axonal loss and visual disability after clinical episode of optic neuritis (ON). Length of optic nerve lesion measured on MRI may be one of them.

The aim of our study is to measure the association between the extent of inflammatory demyelinating process on optic nerve at the acute of ON and the retinal degenerative process following optic nerve injury.

The investigators planned to include 50 patients suffering from a recent clinical episode of ON.

Extent of demyelinating inflammatory process will be assessed by the length of optic nerve double inversion recovery (DIR) hypersignal at the acute phase of ON.

The axonal degenerative process following optic nerve demyelinating injury will be assessed by retinal atrophy measured on optical coherence tomography at 12 months after ON, by visual disability measured on low vision contrast acuity scale and by microstructural quality analysis of optic nerve measured on diffusion tensor imaging sequence of the optic nerve.

Study Type

Observational

Enrollment (Actual)

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
- - Lille, France
    - Hopital Roger Salengro, CHRU de Lille

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from a recent clinical episode of ON suggestive of demyelinating disease as clinically isolated syndrome, multiple sclerosis or neuromyelitis optica spectrum disorders.

Description

Inclusion Criteria:

patient suffering from an acute clinical episode of optic neuritis (ON) confirmed by neurophthalmological examination
< 2 months between start of acute episode of ON and inclusion

Exclusion Criteria:

past history of homolateral episode of ON
retinal diseases
diabeta mellitus
pregnancy

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
Severity of retinal axonal loss around papilla after a clinical episode of optic neuritis Time Frame: 12 months	peripapillary RNFL thickness decrease	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of retinal axonal loss within macula after a clinical episode of optic neuritis Time Frame: 12 months	macular volume decrease	12 months
Severity of visual disability after a clinical episode of optic neuritis Time Frame: 12 months	monocular low contrast (2.5%) vision	12 months
Severity of microstructural architecture of optic nerve after a clinical episode of optic neuritis Time Frame: 12 months	fractional anisotropy	12 months
Progression of optic nerve lesion length Time Frame: 12 months	lesion length in mm measured on 3D-double inversion recovery sequence	12 months

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

Principal Investigator: Olivier Outteryck, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2016

Primary Completion (Actual)

March 11, 2020

Study Completion (Actual)

March 11, 2020

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria