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CompletedNCT03570385DTI et NOIUpdated Nov 9, 2022

Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?

An interventional study of MRI in Optic Neuritis, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-11-09.

Sponsored by Rennes University Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
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Study summary

Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)?

02

Conditions studied

  • Optic Neuritis

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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 40 is below the median of 50 across 58 interventional studies indexed under Optic Neuritis.

Browse Optic Neuritis studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Age from 18 to 55 years old
  • Clinically suspected optic neuritis defined as a sudden decrease of the visual acuity and/or a damage to the field of vision and/or a defect of the colour vision and/or retro-orbital pain with a relative afferent pupillary defect (except if the optic neuropathy is bilateral or symmetrical), in the absence of a severe retinal macular pathology, and in the absence of a toxic or iatrogenic intake (ethambutol, vfend)
  • Clinical optic neuritis duration \< 15 days
  • First episode of an inflammatory ON
  • No in the month before
  • Indication to a corticosteroid therapy at high dose to cure the felt symptomatology
  • Retinal nerve fibre layer (RNFL) thickness upper 75 µm at initial stage
  • Isolated ON, multiple sclerosis or NMO (Neuro Myelitis Optica) - SD (Spectrum Disorder) context
  • Having signed for participating in the study

Exclusion criteria

Exclusion Criteria:

  • to MRI

    • Cardiac pacemaker or defibrillator implant
    • Neurosurgical clips
    • Cochlear implants
    • Intra-orbital or encephalic foreign bodies
    • Stents implanted since less than 4 weeks and osteosynthesis equipment implanted since less than 6 weeks
    • Claustrophobia
  • Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
  • Eye examination suggests a pre-existing eye abnormality that could affect the visual function (amblyopia, strong myopia...)
  • Pregnant or breastfeeding women
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Patient with Optic Neuritis

    Device: MRI

Interventions

  • DeviceMRI

    MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)

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What researchers measure

Primary outcomes

  1. Study of DTI markers in the assessment of the visual prognosis at 6 months of an inflammatory NO based on RNFL thickness (< ou > 75 µm)

    MRI

    Time frame: Month 6

Secondary outcomes

  1. Study of DTI markers in the assessment of the visual prognosis at 6 months of an inflammatory NO based on visual acuity and/or sensible damage to the field of vision

    MRI

    Time frame: Month 6

  2. Comparison of the structural anomalies detected in DTI to the standard morphological MRI (Coronal T2 Fat-Sat MRI and T1 Gadolinium) for ON

    MRI

    Time frame: Month 6

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Study locations

1 site
  • CHU de Rennes
    Rennes, 35033, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2022, 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
NCT03570385
Responsible party
Sponsor
First posted
Jun 27, 2018
Start date
Dec 4, 2017
Primary completion
Jun 24, 2022
Completion
Jun 24, 2022
Last update
Nov 9, 2022

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 completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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