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Not yet recruitingNCT06916182QUESTIONUpdated Apr 8, 2025

Evaluation of Optic Neuritis Using Synthetic Quantitative MRI

An observational study in Optic Neuritis, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

Inflammatory optic neuropathy (optic neuritis) is an acute condition that can affect the optic nerve along its entire course.

It is a rare event, with a prevalence of up to 5 cases per 100,000 people per year, predominantly affecting young individuals (18-50 years old), primarily Caucasian and female. The causes of optic neuropathy are diverse, with the most common being multiple sclerosis, which is the revealing condition in nearly 30% of cases.

MRI is an integral part of the initial assessment of optic neuritis, in conjunction with clinical examination, laboratory tests, and OCT (optical coherence tomography). It plays a crucial role in the acute management of this condition, particularly by guiding the etiological diagnosis and helping adapt the therapeutic approach accordingly.

The establishment of objective and reliable MRI prognostic markers could allow for more precise immediate therapeutic adjustments, thereby improving the prognosis of this potentially severe and debilitating disease, whose treatment itself is not without risks. Indeed, determining the appropriate corticosteroid dose and deciding whether to combine it with other treatments remains a current clinical challenge.

Despite various publications, MRI prognostic criteria for short- and long-term outcomes of optic neuritis remain unclear. Recent studies using radiomics have shown promising results, but these rely on limited sample sizes. New investigative methods are currently under development in the field of medical imaging, particularly "quantitative MRI."

This approach enables effective analysis through mapping techniques, which generate numerical values compared to predetermined references. For instance:

T1 (or R1) mapping assesses fibrosis and, indirectly, myelination, T2 (or R2) mapping evaluates edema. To our knowledge, this approach has never been studied for the optic nerve.

More recently, the emergence of synthetic imaging has made it possible to generate the previously mentioned R1/R2 maps, along with more conventional weighted images (T1, T2, FLAIR, DP), from a single MRI sequence (2D spin-echo sequence). This sequence provides quantitative values while maintaining a short acquisition time (\~5 minutes), which is essential in ophthalmologic imaging, where motion artifacts are frequent.

The goal of this study is to identify prognostic criteria for the evolution of optic neuritis using synthetic quantitative MRI sequences, in the form of threshold numerical values.

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Conditions studied

  • Optic Neuritis

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In context

Optic Neuritis

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

This study's planned enrollment of 100 is below the median of 150 across 25 observational studies indexed under Optic Neuritis.

Browse Optic Neuritis studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient requiring an MRI as part of the diagnosis of optic neuritis.

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

  • Presenting with a painful unilateral decrease in visual acuity for less than one month
  • Referred for contrast-enhanced MRI imaging
  • Explicit consent for participation in the study

Exclusion criteria

Exclusion Criteria:

  • Ophthalmological diagnosis other than optic neuritis explaining the symptoms
  • Known history of optic neuritis (same eye or contralateral eye)
  • Ophthalmological history interfering with the interpretation of ophthalmologic examinations (severe myopia, retinopathy)
  • Known glaucoma (same eye or contralateral eye)
  • Known diabetes
  • Patient under legal protection
  • Pregnant or breastfeeding woman
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherMRI sequence

    This sequence is a 2D spin-echo sequence for the generation of synthetic maps

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What researchers measure

Primary outcomes

  1. visual function at 4 months (ordinal outcome)

    Visual function will be categorized into four stages: 1. Normal visual acuity , normal visual field, and OCT, with no identified sequelae. 2. Normal visual acuity and visual field, but sequelae identified on OCT (ganglion cells or pRNFL). 3. Normal visual acuity but an abnormal visual field. 4. Persistently abnormal visual acuity. Definitions: Normal visual acuity: * For bilateral optic neuritis: visual acuity ≥ 10/10. * For unilateral optic neuritis: visual acuity ≥ that of the contralateral (unaffected) eye. Normal visual field: Mean deviation (MD) \> -3 dB. Normal OCT (ganglion cell layer and pRNFL): Values within the normal range according to the manufacturer's reference data, adjusted for age.

    Time frame: 4 months after inclusion

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06916182
Responsible party
Sponsor
First posted
Apr 8, 2025
Start date
Jun 2025 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Apr 8, 2025

Study contacts

Amélie Yavchitz, MD-PHD
Contact
ayavchitz@for.paris
+33148036454

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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