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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03651362

Acronym

IRMANO

Enrollment

Registered

2018-08-29

Start date

2016-02-29

Completion date

2020-03-11

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Neuritis

Keywords

optic neuritis, DIR, visual disability, CIS, multiple sclerosis, NMOSD

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results