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Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool (MS Predictor)

9 luglio 2026 aggiornato da: 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:

  1. Incident diagnosis of MS following a first episode of optic neuritis, including time to MS diagnosis.
  2. Visual outcomes following optic neuritis, including visual acuity, visual field, and colour vision.
  3. Clinical care received following optic neuritis, including specialist review, investigations/tests
  4. Health-related and vision-related quality of life.
  5. Health economic impacts and healthcare utilisation after experiencing optic neuritis
  6. Knowledge, attitudes, and practices/behaviours about using genetic information to predict future MS disease risk.

If consented, participants will:

  1. Allow researchers to review information from their medical records relating to their optic neuritis diagnosis, investigations, treatments, and outcomes.
  2. Be invited to provide a saliva sample for genetic analysis.
  3. Complete questionnaires about their lifestyle/risk factors, quality of life, and views on genetic risk prediction.
  4. Allow researchers to track long-term health outcomes using information from their NHS records

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

180

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Regno Unito
      • London, Regno Unito, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
        • Contatto:
          • Neringa Jurkute, MD, PhD, FEBOphth
          • Numero di telefono: +44 20 7253 3411
          • Email: n.jurkute@nhs.net
        • Investigatore principale:
          • Neringa Jurkute, MD, PhD, FEBOphth
      • London, Regno Unito, SE5 9RS
        • King's College Hospital NHS Foundation Trust
        • Contatto:
        • Investigatore principale:
          • James McHugh, FRCOphth
      • London, Regno Unito, SE1 7EH
        • Guy's and St Thomas' NHS Foundation Trust
        • Contatto:
        • Investigatore principale:
          • Tasanee Braithwaite, FRCOphth

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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)

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: No Intervention: Observational Cohort
Not applicable - No intervention as this is an observation study

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis
Lasso di tempo: Extracted from retrospective record at baseline, and reviewed before study end to capture any new events occurring during the 12 month study period.
Occurrence of a diagnosis of multiple sclerosis following a first episode of optic neuritis.
Extracted from retrospective record at baseline, and reviewed before study end to capture any new events occurring during the 12 month study period.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Acuity (LogMAR)
Lasso di tempo: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
Visual acuity (LogMAR) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments.
From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
Visual Field Mean Deviation (dB)
Lasso di tempo: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
Visual field mean deviation (Decibels) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments
From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
Colour Vision (Number of Ishihara Plates Correctly Identified)
Lasso di tempo: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
Colour vision assessed using Ishihara pseudoisochromatic plates and reported as the number of plates correctly identified.
From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
Number of Healthcare Consultations Following Optic Neuritis Diagnosis
Lasso di tempo: 12 months
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.
12 months
Number of Investigations Performed Following Optic Neuritis Diagnosis
Lasso di tempo: 12 months
Number of investigations performed following optic neuritis diagnosis, reported by investigation type, including OCT, visual field testing, MRI, VEP, blood tests, and CSF analysis.
12 months
Time to Diagnostic Investigations Following Optic Neuritis Diagnosis (Days)
Lasso di tempo: 12 months
Time interval (days) from optic neuritis diagnosis to each investigation, reported by investigation type.
12 months
Time to Treatment Following Optic Neuritis Diagnosis (Days)
Lasso di tempo: 12 months
Time interval (Days) from optic neuritis diagnosis to initiation of first treatment course, reported by treatment type.
12 months
Number of Treatment Episodes Following Optic Neuritis Diagnosis
Lasso di tempo: 12 months
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).
12 months
Health-Related Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire [EQ-5D-5L])
Lasso di tempo: Measured at baseline recruitment and repeated 3-12 months later
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.
Measured at baseline recruitment and repeated 3-12 months later
Vision-Related Quality of Life (National Eye Institute Visual Function Questionnaire-25 [NEI-VFQ-25])
Lasso di tempo: Baseline and repeated 3-12 months later
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.
Baseline and repeated 3-12 months later
Optic Neuritis-Related Quality of Life (Semi-Structured Questionnaire)
Lasso di tempo: Measured at baseline recruitment and repeated 3-12 months later
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
Measured at baseline recruitment and repeated 3-12 months later
Fatigue (Patient-Reported Outcomes Measurement Information System [PROMIS] Fatigue 6a)
Lasso di tempo: Baseline recruitment and repeated once 3-12 months later
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).
Baseline recruitment and repeated once 3-12 months later
Depression (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression 4a)
Lasso di tempo: Baseline recruitment and repeated once 3-12 months later
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).
Baseline recruitment and repeated once 3-12 months later
Work Productivity Loss (Adapted iMTA Productivity Cost Questionnaire [iPCQ])
Lasso di tempo: Baseline recruitment and repeated once 3-12 months later
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)
Baseline recruitment and repeated once 3-12 months later
Healthcare Resource Utilisation: Appointments, Emergency Department Attendances and Hospital Admissions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])
Lasso di tempo: Baseline recruitment and repeated once 3-12 months later
Participant-reported utilisation of healthcare services related to optic neuritis or associated diseases, including appointments with healthcare professionals, emergency department attendances, and hospital admissions
Baseline recruitment and repeated once 3-12 months later
Healthcare Resource Utilisation: Investigations and Treatment Interventions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])
Lasso di tempo: Baseline recruitment and repeated once 3-12 months later
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.
Baseline recruitment and repeated once 3-12 months later
Informal Care Received (Hours)
Lasso di tempo: Baseline recruitment and repeated once 3-12 months later
Participant-reported hours of informal care received from family members, friends or acquaintances because of optic neuritis or associated diseases.
Baseline recruitment and repeated once 3-12 months later
Out-of-Pocket Costs (Pounds Sterling)
Lasso di tempo: Baseline recruitment and repeated once 3-12 months later
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)
Baseline recruitment and repeated once 3-12 months later
Knowledge, Attitudes and Practices/Behaviours Regarding Genetic Risk Prediction (KAP Questionnaire)
Lasso di tempo: Baseline recruitment and repeated at 3-12 months later
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.
Baseline recruitment and repeated at 3-12 months later

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

King's College London

Collaboratori

King's College Hospital NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Moorfields Eye Hospital NHS Foundation Trust

Investigatori

  • Investigatore principale: Tasanee Braithwaite, King's College London

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 luglio 2026

Primo Inserito (Effettivo)

15 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 352834
  • 222 (Altro numero di sovvenzione/finanziamento: MS Society UK)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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