Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool (MS Predictor)
9 juli 2026 uppdaterad av: 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
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
180
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Tasanee Braithwaite, Doctor of Medicine (Oxon)
- Telefonnummer: +44 20 7188 7188
- E-post: tasanee.braithwaite@kcl.ac.uk
Studieorter
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-
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London, Storbritannien, EC1V 2PD
- Moorfields Eye Hospital NHS Foundation Trust
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Kontakt:
- Neringa Jurkute, MD, PhD, FEBOphth
- Telefonnummer: +44 20 7253 3411
- E-post: n.jurkute@nhs.net
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Huvudutredare:
- Neringa Jurkute, MD, PhD, FEBOphth
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London, Storbritannien, SE5 9RS
- King's College Hospital NHS Foundation Trust
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Kontakt:
- James McHugh, FRCOphth
- Telefonnummer: +44 20 3299 9000
- E-post: james.mchugh@kcl.ac.uk
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Huvudutredare:
- James McHugh, FRCOphth
-
London, Storbritannien, SE1 7EH
- Guy's and St Thomas' NHS Foundation Trust
-
Kontakt:
- Tasanee Braithwaite, FRCOphth
- Telefonnummer: +44 20 7188 7188
- E-post: tasanee.braithwaite@kcl.ac.uk
-
Huvudutredare:
- Tasanee Braithwaite, FRCOphth
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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)
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Acuity (LogMAR)
Tidsram: 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.
|
From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
|
|
Visual Field Mean Deviation (dB)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
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Number of Investigations Performed Following Optic Neuritis Diagnosis
Tidsram: 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)
Tidsram: 12 months
|
Time interval (days) from optic neuritis diagnosis to each investigation, reported by investigation type.
|
12 months
|
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Time to Treatment Following Optic Neuritis Diagnosis (Days)
Tidsram: 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
Tidsram: 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])
Tidsram: 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
|
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Vision-Related Quality of Life (National Eye Institute Visual Function Questionnaire-25 [NEI-VFQ-25])
Tidsram: 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)
Tidsram: 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)
Tidsram: 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).
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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)
Tidsram: 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).
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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])
Tidsram: 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])
Tidsram: 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
|
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Healthcare Resource Utilisation: Investigations and Treatment Interventions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])
Tidsram: 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.
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Baseline recruitment and repeated once 3-12 months later
|
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Informal Care Received (Hours)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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.
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Baseline recruitment and repeated at 3-12 months later
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Tasanee Braithwaite, King's College London
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 december 2027
Avslutad studie (Beräknad)
1 december 2027
Studieregistreringsdatum
Först inskickad
18 juni 2026
Först inskickad som uppfyllde QC-kriterierna
9 juli 2026
Första postat (Faktisk)
15 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 juli 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i nervsystemet
- Patologiska processer
- Sjukdomsegenskaper
- Autoimmuna sjukdomar
- Immunsystemets sjukdomar
- Ögonsjukdomar
- Överkänslighet
- Demyeliniserande autoimmuna sjukdomar, CNS
- Autoimmuna sjukdomar i nervsystemet
- Demyeliniserande sjukdomar
- Lymfatiska sjukdomar
- Lymfoproliferativa störningar
- Myelit, tvärgående
- Synnervssjukdomar
- Kranial nervsjukdomar
- Överkänslighet, försenad
- Mottaglighet för sjukdomar
- Genetisk predisposition för sjukdom
- Patologiska tillstånd, tecken och symtom
- Hemiska och lymfsjukdomar
- Genetiskt riskpoäng
- Multipel skleros
- Neuromyelit Optica
- Sarcoidos
- Optisk neurit
Andra studie-ID-nummer
- 352834
- 222 (Annat bidrag/finansieringsnummer: MS Society UK)
Plan för individuella deltagardata (IPD)
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