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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)?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03570385
Acronym
DTI et NOI
Enrollment
40
Registered
2018-06-27
Start date
2017-12-04
Completion date
2022-06-24
Last updated
2022-11-09

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

Conditions

Optic Neuritis

Brief summary

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

Interventions

DEVICEMRI

MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Interventional pilot study with minimal risks and constraints, descriptive, prospective, monocentric

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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)Month 6MRI

Secondary

MeasureTime frameDescription
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 visionMonth 6MRI
Comparison of the structural anomalies detected in DTI to the standard morphological MRI (Coronal T2 Fat-Sat MRI and T1 Gadolinium) for ONMonth 6MRI

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026