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OpenTrials
Completed

NCT Number: NCT03651362

Linking Optic Nerve MRI and the Retinal Axonal Loss After 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHRU de Lille

Lille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Severity of retinal axonal loss around papilla after a clinical episode of optic neuritis

    Time frame: 12 months

    peripapillary RNFL thickness decrease

Secondary outcomes

  1. Severity of retinal axonal loss within macula after a clinical episode of optic neuritis

    Time frame: 12 months

    macular volume decrease

  2. Severity of visual disability after a clinical episode of optic neuritis

    Time frame: 12 months

    monocular low contrast (2.5%) vision

  3. Severity of microstructural architecture of optic nerve after a clinical episode of optic neuritis

    Time frame: 12 months

    fractional anisotropy

  4. Progression of optic nerve lesion length

    Time frame: 12 months

    lesion length in mm measured on 3D-double inversion recovery sequence

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: IRMANO

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2018
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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