Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool (MS Predictor)
9 de julio de 2026 actualizado por: King's College London
Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool (MS Predictor)
The goal of this observational study is to determine whether genetic information, together with clinical information, can be used to improve prediction of future multiple sclerosis (MS) diagnosis after a first-time episode of optic neuritis. The study will also investigate visual outcomes, quality of life, healthcare use, and the acceptability of using genetic information to predict future health outcomes in people with optic neuritis.
The main outcomes that we aim to assess are:
- Incident diagnosis of MS following a first episode of optic neuritis, including time to MS diagnosis.
- Visual outcomes following optic neuritis, including visual acuity, visual field, and colour vision.
- Clinical care received following optic neuritis, including specialist review, investigations/tests
- Health-related and vision-related quality of life.
- Health economic impacts and healthcare utilisation after experiencing optic neuritis
- Knowledge, attitudes, and practices/behaviours about using genetic information to predict future MS disease risk.
If consented, participants will:
- Allow researchers to review information from their medical records relating to their optic neuritis diagnosis, investigations, treatments, and outcomes.
- Be invited to provide a saliva sample for genetic analysis.
- Complete questionnaires about their lifestyle/risk factors, quality of life, and views on genetic risk prediction.
- Allow researchers to track long-term health outcomes using information from their NHS records
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
180
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Tasanee Braithwaite, Doctor of Medicine (Oxon)
- Número de teléfono: +44 20 7188 7188
- Correo electrónico: tasanee.braithwaite@kcl.ac.uk
Ubicaciones de estudio
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London, Reino Unido, EC1V 2PD
- Moorfields Eye Hospital NHS Foundation Trust
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Contacto:
- Neringa Jurkute, MD, PhD, FEBOphth
- Número de teléfono: +44 20 7253 3411
- Correo electrónico: n.jurkute@nhs.net
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Investigador principal:
- Neringa Jurkute, MD, PhD, FEBOphth
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London, Reino Unido, SE5 9RS
- King's College Hospital NHS Foundation Trust
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Contacto:
- James McHugh, FRCOphth
- Número de teléfono: +44 20 3299 9000
- Correo electrónico: james.mchugh@kcl.ac.uk
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Investigador principal:
- James McHugh, FRCOphth
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London, Reino Unido, SE1 7EH
- Guy's and St Thomas' NHS Foundation Trust
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Contacto:
- Tasanee Braithwaite, FRCOphth
- Número de teléfono: +44 20 7188 7188
- Correo electrónico: tasanee.braithwaite@kcl.ac.uk
-
Investigador principal:
- Tasanee Braithwaite, FRCOphth
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Participants aged 16 and above with a history of a first episode of optic neuritis recruited from one of the three participating NHS sites in London (Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Foundation Trust and Moorfields Eye Hospital NHS Foundation Trust)
Descripción
Inclusion Criteria:
- Aged 16 years and above at time of consent
- Previous episode of optic neuritis diagnosed at one of the participating sites
Exclusion Criteria:
- Patients for whom data relating to the first episode of ON are not available in the medical record at a participating site
- Children <16 years at the time of recruitment
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Participants Who Have Experienced Optic Neuritis
Participants with a history of a first episode of optic neuritis recruited from the 3 participating NHS hospitals. Participants will undergo retrospective review of clinical records, complete questionnaires, and may provide a saliva sample for genetic analysis. Participants will be invited to consent to longer term prospective outcome assessment. |
Not applicable - No intervention as this is an observation study
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis
Periodo de tiempo: Extracted from retrospective record at baseline, and reviewed before study end to capture any new events occurring during the 12 month study period.
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Occurrence of a diagnosis of multiple sclerosis following a first episode of optic neuritis.
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Extracted from retrospective record at baseline, and reviewed before study end to capture any new events occurring during the 12 month study period.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Acuity (LogMAR)
Periodo de tiempo: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
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Visual acuity (LogMAR) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments.
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From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
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|
Visual Field Mean Deviation (dB)
Periodo de tiempo: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
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Visual field mean deviation (Decibels) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments
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From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
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Colour Vision (Number of Ishihara Plates Correctly Identified)
Periodo de tiempo: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
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Colour vision assessed using Ishihara pseudoisochromatic plates and reported as the number of plates correctly identified.
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From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
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Number of Healthcare Consultations Following Optic Neuritis Diagnosis
Periodo de tiempo: 12 months
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Number of healthcare consultations attended following optic neuritis diagnosis, reported by consultation type, including primary care appointments, emergency department attendances, neuro-ophthalmology, neurology, and other relevant specialist clinics.
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12 months
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Number of Investigations Performed Following Optic Neuritis Diagnosis
Periodo de tiempo: 12 months
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Number of investigations performed following optic neuritis diagnosis, reported by investigation type, including OCT, visual field testing, MRI, VEP, blood tests, and CSF analysis.
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12 months
|
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Time to Diagnostic Investigations Following Optic Neuritis Diagnosis (Days)
Periodo de tiempo: 12 months
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Time interval (days) from optic neuritis diagnosis to each investigation, reported by investigation type.
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12 months
|
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Time to Treatment Following Optic Neuritis Diagnosis (Days)
Periodo de tiempo: 12 months
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Time interval (Days) from optic neuritis diagnosis to initiation of first treatment course, reported by treatment type.
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12 months
|
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Number of Treatment Episodes Following Optic Neuritis Diagnosis
Periodo de tiempo: 12 months
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Number of treatment episodes received following optic neuritis diagnosis, reported by treatment type (e.g.
intravenous corticosteroids, oral corticosteroids, plasma exchange, intravenous immunoglobulin, disease-modifying therapies).
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12 months
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Health-Related Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire [EQ-5D-5L])
Periodo de tiempo: Measured at baseline recruitment and repeated 3-12 months later
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Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L).
The EQ-5D-5L descriptive system comprises five domains, each scored on five levels.
Higher levels indicate worse health status and poorer health-related quality of life.
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Measured at baseline recruitment and repeated 3-12 months later
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Vision-Related Quality of Life (National Eye Institute Visual Function Questionnaire-25 [NEI-VFQ-25])
Periodo de tiempo: Baseline and repeated 3-12 months later
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Vision-related quality of life assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) composite score.
Scores range from 0 to 100, with higher scores indicating better vision-related quality of life.
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Baseline and repeated 3-12 months later
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Optic Neuritis-Related Quality of Life (Semi-Structured Questionnaire)
Periodo de tiempo: Measured at baseline recruitment and repeated 3-12 months later
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Participant-reported optic neuritis-related quality of life and lived experiences, including symptoms, treatment impacts, emotional well-being, activities of daily living, social participation and personal relationships, explored using a bespoke semi-structured questionnaire
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Measured at baseline recruitment and repeated 3-12 months later
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Fatigue (Patient-Reported Outcomes Measurement Information System [PROMIS] Fatigue 6a)
Periodo de tiempo: Baseline recruitment and repeated once 3-12 months later
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Fatigue assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 6a instrument.
Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10 in the reference population.
Higher scores indicate greater fatigue (worse outcome).
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Baseline recruitment and repeated once 3-12 months later
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Depression (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression 4a)
Periodo de tiempo: Baseline recruitment and repeated once 3-12 months later
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Depression assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4a instrument.
Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10 in the reference population.
Higher scores indicate more severe depressive symptoms (worse outcome).
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Baseline recruitment and repeated once 3-12 months later
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Work Productivity Loss (Adapted iMTA Productivity Cost Questionnaire [iPCQ])
Periodo de tiempo: Baseline recruitment and repeated once 3-12 months later
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Participant-reported work productivity loss associated with optic neuritis or related diseases, including absenteeism, presenteeism and changes to employment.
Measured using the Adapted iMTA Productivity Cost Questionnaire (iPCQ)
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Baseline recruitment and repeated once 3-12 months later
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Healthcare Resource Utilisation: Appointments, Emergency Department Attendances and Hospital Admissions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])
Periodo de tiempo: Baseline recruitment and repeated once 3-12 months later
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Participant-reported utilisation of healthcare services related to optic neuritis or associated diseases, including appointments with healthcare professionals, emergency department attendances, and hospital admissions
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Baseline recruitment and repeated once 3-12 months later
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Healthcare Resource Utilisation: Investigations and Treatment Interventions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])
Periodo de tiempo: Baseline recruitment and repeated once 3-12 months later
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Participant-reported utilisation of diagnostic investigations and therapeutic interventions related to optic neuritis or associated diseases, including imaging, laboratory investigations, electrophysiological testing, and treatments received.
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Baseline recruitment and repeated once 3-12 months later
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Informal Care Received (Hours)
Periodo de tiempo: Baseline recruitment and repeated once 3-12 months later
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Participant-reported hours of informal care received from family members, friends or acquaintances because of optic neuritis or associated diseases.
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Baseline recruitment and repeated once 3-12 months later
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Out-of-Pocket Costs (Pounds Sterling)
Periodo de tiempo: Baseline recruitment and repeated once 3-12 months later
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Participant-reported personal expenditure related to optic neuritis and associated diseases in the first year after optic neuritis began (e.g.
health insurance, prescription costs, optician/sight tests, low vision aids)
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Baseline recruitment and repeated once 3-12 months later
|
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Knowledge, Attitudes and Practices/Behaviours Regarding Genetic Risk Prediction (KAP Questionnaire)
Periodo de tiempo: Baseline recruitment and repeated at 3-12 months later
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This will be explored using a knowledge, attitudes and practices/behaviour questionnaire to explore how participants feel about the use of genetic information to predict future health outcome risk including multiple sclerosis.
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Baseline recruitment and repeated at 3-12 months later
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Tasanee Braithwaite, King's College London
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Panthagani J, O'Donovan C, Aiyegbusi OL, Liu X, Bayliss S, Calvert M, Pesudovs K, Denniston AK, Moore DJ, Braithwaite T. Evaluating patient-reported outcome measures (PROMs) for future clinical trials in adult patients with optic neuritis. Eye (Lond). 2023 Oct;37(15):3097-3107. doi: 10.1038/s41433-023-02478-z. Epub 2023 Mar 17.
- Braithwaite T, Wiegerinck N, Petzold A, Denniston A. Vision Loss from Atypical Optic Neuritis: Patient and Physician Perspectives. Ophthalmol Ther. 2020 Jun;9(2):215-220. doi: 10.1007/s40123-020-00247-9. Epub 2020 Mar 21.
- Laviers H, Petzold A, Braithwaite T. How far should I manage acute optic neuritis as an ophthalmologist? A United Kingdom perspective. Eye (Lond). 2024 Aug;38(12):2238-2245. doi: 10.1038/s41433-024-03164-4. Epub 2024 Jun 12.
- Petzold A, Braithwaite T, van Oosten BW, Balk L, Martinez-Lapiscina EH, Wheeler R, Wiegerinck N, Waters C, Plant GT. Case for a new corticosteroid treatment trial in optic neuritis: review of updated evidence. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):9-14. doi: 10.1136/jnnp-2019-321653. Epub 2019 Nov 18. No abstract available.
- Braithwaite T, Subramanian A, Petzold A, Galloway J, Adderley NJ, Mollan SP, Plant GT, Nirantharakumar K, Denniston AK. Trends in Optic Neuritis Incidence and Prevalence in the UK and Association With Systemic and Neurologic Disease. JAMA Neurol. 2020 Dec 1;77(12):1514-1523. doi: 10.1001/jamaneurol.2020.3502.
- Loginovic P, Wang F, Li J, Ferrat L, Mirshahi UL, Rao HS, Petzold A, Tyrrell J, Green HD, Weedon MN, Ganna A, Tuomi T, Carey DJ; UKBB Eye & Vision Consortium; FinnGen; Geisinger-Regeneron DiscovEHR Collaboration; Oram RA, Braithwaite T. Applying a genetic risk score model to enhance prediction of future multiple sclerosis diagnosis at first presentation with optic neuritis. Nat Commun. 2024 Feb 28;15(1):1415. doi: 10.1038/s41467-024-44917-9.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
18 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2026
Publicado por primera vez (Actual)
15 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Procesos Patológicos
- Atributos de la enfermedad
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades de los ojos
- Hipersensibilidad
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Mielitis Transversa
- Enfermedades del nervio óptico
- Enfermedades de los nervios craneales
- Hipersensibilidad Retrasada
- Susceptibilidad a la enfermedad
- Predisposición genética a la enfermedad
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Puntuación de riesgo genético
- Esclerosis múltiple
- Neuromielitis óptica
- Sarcoidosis
- Neuritis óptica
Otros números de identificación del estudio
- 352834
- 222 (Otro número de subvención/financiamiento: MS Society UK)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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