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

R

Rennes University Hospital

Status

Completed

Conditions

Optic Neuritis

Treatments

Device: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT03570385
35RC17_8828_DTI et NOI

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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 corticosteroids 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 informed consent for participating in the study

Exclusion criteria

  • Contra-indication 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Patient with Optic Neuritis
Experimental group
Treatment:
Device: MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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