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CompletedNCT03651362IRMANOUpdated Dec 11, 2025

Linking Optic Nerve MRI and the Retinal Axonal Loss After Optic Neuritis

An observational study in Optic Neuritis, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
46
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Optic Neuritis

Keywords

  • optic neuritis
  • DIR
  • visual disability
  • CIS
  • multiple sclerosis
  • NMOSD
03

In context

Optic Neuritis

88 studies on the registry are indexed under Optic Neuritis; 16 are open to participants now.

This study's enrollment of 46 is below the median of 150 across 25 observational studies indexed under Optic Neuritis.

Browse Optic Neuritis studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • past history of homolateral episode of ON
  • retinal diseases
  • diabeta mellitus
  • pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
46 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    peripapillary RNFL thickness decrease

    Time frame: 12 months

Secondary outcomes

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

    macular volume decrease

    Time frame: 12 months

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

    monocular low contrast (2.5%) vision

    Time frame: 12 months

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

    fractional anisotropy

    Time frame: 12 months

  4. Progression of optic nerve lesion length

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

    Time frame: 12 months

07

Study locations

1 site
  • Hôpital Roger Salengro, CHRU de Lille
    Lille, France
08

References and documents

Publications

  • Hodel J, Outteryck O, Bocher AL, Zephir H, Lambert O, Benadjaoud MA, Chechin D, Pruvo JP, Vermersch P, Leclerc X. Comparison of 3D double inversion recovery and 2D STIR FLAIR MR sequences for the imaging of optic neuritis: pilot study. Eur Radiol. 2014 Dec;24(12):3069-75. doi: 10.1007/s00330-014-3342-3. Epub 2014 Aug 23. PubMed 25149294 ↗
  • Miller DH, Newton MR, van der Poel JC, du Boulay EP, Halliday AM, Kendall BE, Johnson G, MacManus DG, Moseley IF, McDonald WI. Magnetic resonance imaging of the optic nerve in optic neuritis. Neurology. 1988 Feb;38(2):175-9. doi: 10.1212/wnl.38.2.175. PubMed 3340276 ↗
  • Dunker S, Wiegand W. Prognostic value of magnetic resonance imaging in monosymptomatic optic neuritis. Ophthalmology. 1996 Nov;103(11):1768-73. doi: 10.1016/s0161-6420(96)30429-6. PubMed 8942868 ↗
  • Kallenbach K, Simonsen H, Sander B, Wanscher B, Larsson H, Larsen M, Frederiksen JL. Retinal nerve fiber layer thickness is associated with lesion length in acute optic neuritis. Neurology. 2010 Jan 19;74(3):252-8. doi: 10.1212/WNL.0b013e3181ca0135. PubMed 20083802 ↗
  • Trip SA, Schlottmann PG, Jones SJ, Altmann DR, Garway-Heath DF, Thompson AJ, Plant GT, Miller DH. Retinal nerve fiber layer axonal loss and visual dysfunction in optic neuritis. Ann Neurol. 2005 Sep;58(3):383-91. doi: 10.1002/ana.20575. PubMed 16075460 ↗
  • Hadhoum N, Hodel J, Defoort-Dhellemmes S, Duhamel A, Drumez E, Zephir H, Pruvo JP, Leclerc X, Vermersch P, Outteryck O. Length of optic nerve double inversion recovery hypersignal is associated with retinal axonal loss. Mult Scler. 2016 Apr;22(5):649-58. doi: 10.1177/1352458515598021. Epub 2015 Jul 30. PubMed 26227005 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2016 to primary completion in Mar 2020, 49 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2018
First posted
Aug 29, 2018
StartActual
Feb 2016
Primary completionActual
Mar 11, 2020
CompletionActual
Mar 11, 2020
Last update
Dec 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03651362
Responsible party
Sponsor
First posted
Aug 29, 2018
Start date
Feb 2016
Primary completion
Mar 11, 2020
Completion
Mar 11, 2020
Last update
Dec 11, 2025

Study contacts

Olivier Outteryck, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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