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

NCT03570385 | Completed

• 1 other identifier: 35RC17_8828_DTI et NOI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Optic Neuritis

Outcome Measures

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)

  MRI

  Month 6

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

Patient with Optic Neuritis

EXPERIMENTAL

Device: MRI

Interventions

MRI DEVICE

MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)

Patient with Optic Neuritis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Optic Neuritis

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: June 27, 2018
• Study Start: December 4, 2017
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)