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

9 lipca 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

180

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Zjednoczone Królestwo
      • London, Zjednoczone Królestwo, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
        • Kontakt:
          • Neringa Jurkute, MD, PhD, FEBOphth
          • Numer telefonu: +44 20 7253 3411
          • E-mail: n.jurkute@nhs.net
        • Główny śledczy:
          • Neringa Jurkute, MD, PhD, FEBOphth
      • London, Zjednoczone Królestwo, SE5 9RS
        • King's College Hospital NHS Foundation Trust
        • Kontakt:
        • Główny śledczy:
          • James McHugh, FRCOphth
      • London, Zjednoczone Królestwo, SE1 7EH
        • Guy's and St Thomas' NHS Foundation Trust
        • Kontakt:
        • Główny śledczy:
          • Tasanee Braithwaite, FRCOphth

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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)

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Inny: No Intervention: Observational Cohort
Not applicable - No intervention as this is an observation study

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Visual Acuity (LogMAR)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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])
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

King's College London

Współpracownicy

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

Śledczy

  • Główny śledczy: Tasanee Braithwaite, King's College London

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2027

Ukończenie studiów (Szacowany)

1 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

18 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 lipca 2026

Pierwszy wysłany (Rzeczywisty)

15 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 lipca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 352834
  • 222 (Inny numer grantu/finansowania: MS Society UK)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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