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Adding the Optic Nerve in Multiple Sclerosis Diagnostic Criteria: A Longitudinal, Prospective, Multicenter Study
Open accessAbstract
BACKGROUND AND OBJECTIVES: The optic nerve is not one of the areas of the CNS that can be used to demonstrate dissemination in space (DIS) within the 2017 McDonald criteria for the diagnosis of multiple sclerosis (MS). Objectives were (1) to assess whether optic nerve-MRI (ON-MRI), optical coherence tomography (OCT), and visual evoked potentials (VEP) detect optic nerve involvement in clinically isolated syndrome (CIS) and (2) to evaluate the contribution of the optic nerve topography to the current diagnostic criteria in a prospective, multicenter cohort. METHODS: MAGNIMS centers were invited to provide prospective data on patients with CIS who underwent a visual assessment with at least 2 of 3 investigations (ON-MRI, OCT, or VEP) within 6 months of onset. Modified DIS criteria were constructed by adding the optic nerve topography, defined by each investigation separately and any combination of them, as the fifth area of the CNS. A risk assessment analysis and the performance of the different DIS criteria were analyzed using the diagnosis of MS according to the 2017 McDonald criteria as the primary outcome and new T2 lesions and/or a second relapse as the secondary outcome. RESULTS: We included 157 patients with CIS from 5 MAGNIMS centers; 60/157 (38.2%) patients presented with optic neuritis. Optic nerve involvement on ON-MRI was found in 40.2% patients at study entry and in 72.5% of those with optic neuritis.At follow-up (mean 27.9 months, SD 14.5), 111/157 patients (70.7%) were diagnosed with MS according to the 2017 McDonald criteria. Fulfilling either 2017 DIS or any modified DIS criteria conferred a similar high risk for reaching primary and secondary outcomes. The modified DIS criteria had higher sensitivity (92.5% [with ON-MRI] vs 88.2%), but slightly lower specificity (80.0% [with GCIPL IEA ≥4 μm] vs 82.2%), with overall similar accuracy (86.6% [with ON-MRI] vs 86.5%) than 2017 DIS criteria. Consistent results were found for secondary outcomes. DISCUSSION: In patients with CIS, the presence of an optic nerve lesion defined by MRI, OCT, or VEP is frequently detected, especially when presenting with optic neuritis. Our study supports the addition of the optic nerve as a fifth topography to fulfill DIS criteria.
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“recent works that demonstrated that optic nerve lesions have significant diagnostic yield and improve early classification of MS.”
From Applying the 2024-revised McDonald criteria for multiple sclerosis using conventional diagnostic tools: a single-centre prospective cohort study in Germany (2026) · cites this paper as [29]
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“Overall, compared with the unmodified criteria, including the optic nerve resulted in an increase in sensitivity, with a slight decrease in specificity.”
From The use of optical coherence tomography and visual evoked potentials in the 2024 McDonald diagnostic criteria for multiple sclerosis (2025) · cites this paper as [64]
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Metadata
- Authors
- Vidal-Jordana, A., Rovira, A., Calderon, W., Arrambide, G., Castilló, J., Moncho, D., Rahnama, K., Collorone, S., Toosy, A. T., Ciccarelli, O., Papadopoulou, A., Cerdá-Fuertes, N., Lieb, J. M., Ruggieri, S., Tortorella, C., Gasperini, C., Bisecco, A., Capuano, R., Gallo, A., De Barros, A., Salerno, A., Auger, C., Sastre-Garriga, J., Tintore, M., Montalban, X., & MAGNIMS, F.
- Affiliations
- From the Hospital Universitari Vall d'Hebron (A.V.-J., A.R., G.A., J.C., D.M., K.R., A.D.B., A.S., C.A., J.S.-G., M.T., X.M.), Barcelona, Spain; Vall d'Hebron Research Institute (VHIR) (W.C.), Universitat Autònoma de Barcelona, Spain; University College London (UCL) (S.C., A.T.T., O.C.), United Kingdom; Institute of Neurology (O.C.), London, United Kingdom; University Hospital Basel (A.P., N.C.-F., J.M.L.), Switzerland; San Camillo-Forlanini Hospital (S.R., C.T., C.G.), Rome, Italy; University of...
- Universitat Autònoma de Barcelona (ES)
- ORCID
- Vidal-Jordana, Angela
- Calderon, Willem
- Arrambide, Georgina
- Castilló, Joaquín
- Moncho, Dulce
- Rahnama, Kimia
- Collorone, Sara
- Toosy, Ahmed T.
- Ciccarelli, Olga
- Papadopoulou, Athina
- Cerdá-Fuertes, Nuria
- Lieb, Johanna M.
- Ruggieri, Serena
- Tortorella, Carla
- Gasperini, Claudio
- Bisecco, Alvino
- Capuano, Rocco
- Gallo, Antonio
- Salerno, Annalaura
- Auger, Cristina
- Sastre-Garriga, Jaume
- Tintore, Mar
- Montalban, Xavier
- Venue
- Neurology
- Published
- 2024-01-09
- Volume
- 102
- Issue
- 1
- Pages
- e200805-e200805
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- PMC
- PMC10834130
- OpenAlex
- W4389697835
- Cited by
- 88
- References
- 36
- Citations by year
- 2026: 37 · 2025: 33 · 2024: 17
- FWCI
- 17.45
- Type
- journal article
- Language
- en
- Update notices
- correction (2024-03-28)
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Neurology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- Funders
- Sanofi
- Biogen
- Teva Pharmaceutical Industries
- European Committee for Treatment and Research in Multiple Sclerosis
- National Institute for Health and Care Research (RP-2017-08-ST2-004)
- Rosetrees Trust (PGL21/10079, MS632)
- MedDay Pharmaceuticals
- Medical Research Council (MR/S026088/1)
- Instituto de Salud Carlos III (PI17/02162)
- Topics
- Health Sciences › Medicine › Clinical Neurology › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › Family Practice › Clinical Reasoning and Diagnostic Skills
- Health Sciences › Medicine › Ophthalmology › Glaucoma and retinal disorders
- Keywords
- multiple sclerosis, clinically isolated syndrome, optic nerve involvement, dissemination in space, 2017 McDonald criteria, optic neuritis, optical coherence tomography, visual evoked potentials, diagnostic accuracy, relapse risk, T2 lesions, risk stratification, disease-modifying therapy
- MeSH terms
- Demyelinating Diseases, Evoked Potentials, Visual, Humans, Multiple Sclerosis, Optic Nerve, Optic Neuritis, Prospective Studies
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