Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome
Evaluation of the Predictive Value of the Optic Nerve Involvement at the Stage of Clinically Isolated Syndrome, for the Diagnosis of Clinically Definite Multiple Sclerosis and the Delay of Second Relapses' Occurrence
University Hospital, Lille
200 participants
Jul 17, 2025
INTERVENTIONAL
Conditions
Summary
Optic neuritis (ON) represents around 30% of clinical presentation of clinically isolated syndrome (CIS). Asymptomatic optic nerve involvement is very frequent in all stage of multiple sclerosis (MS) disease including the CIS. However, optic nerve is still not part of MS diagnosis criteria. The main objective of our regional and multicenter study is to evaluate the prognostic value of optic nerve involvement at the earliest clinical stage of MS (=CIS) for the diagnosis of clinically definite MS (2nd clinical relapse) and the delay until the 2nd relapse.
Eligibility
Inclusion Criteria4
- Patients between 18 and 55 years old
- Occurrence of CIS ≤ 6 months
- With two T2 hypersignals on brain/spinal cord MRI suggestive of MS or with oligoclonal bands
- Giving their written informed consent
Exclusion Criteria7
- Pathological conditions that may skew the optic nerve MRI and/or retinal OCT (diabetes mellitus, glaucoma, retinopathy, ametropia \>6 dioptria)
- Past history of MS relapses
- Extensive myelitis (\>3 vertebral bodies)
- Bilateral optic neuritis without T2 lesions suggestive of MS
- Contra-indication to MRI, gadolinium injection
- Pregnancy, breast-feeding
- Patients unable to consent
Interventions
Systematic optic nerve MRI sequence during the CIS diagnosis work-up. This sequence is not done systematically and not recommended for now (except in case of acute ON). The interventional nature of the study remains minimal
Locations(1)
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NCT06455332