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Completed

NCT Number: NCT03570385

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

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

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Key information

Conditions

Optic Neuritis Cranial Nerve Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Rennes

Rennes, 35033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)

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)

    Time frame: Month 6

    MRI

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

    Time frame: Month 6

    MRI

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

    Time frame: Month 6

    MRI

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: DTI et NOI

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2018
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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