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

Optic Neuritis Clinical Trial

— DTI et NOI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570385
• Other study ID #: 35RC17_8828_DTI et NOI
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: June 24, 2022

Study information

• Verified date: November 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 24, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

Device:
• MRI
MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Month 6
Secondary	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	Month 6
Secondary	Comparison of the structural anomalies detected in DTI to the standard morphological MRI (Coronal T2 Fat-Sat MRI and T1 Gadolinium) for ON	MRI	Month 6