Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?
Not Applicable
Completed
- Conditions
- Optic Neuritis
- Registration Number
- NCT03570385
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 6 MRI
- Secondary Outcome Measures
Name Time Method 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 Month 6 MRI
Comparison of the structural anomalies detected in DTI to the standard morphological MRI (Coronal T2 Fat-Sat MRI and T1 Gadolinium) for ON Month 6 MRI
Trial Locations
- Locations (1)
CHU de Rennes
🇫🇷Rennes, France
CHU de Rennes🇫🇷Rennes, France