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NCT Number: NCT07704294

Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool

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

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Key information

Conditions

Optic Neuritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Disease Susceptibility Eye Diseases Genetic Predisposition to Disease Genetic Risk Score Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders Multiple Sclerosis Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Optic Nerve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sarcoid Sarcoidosis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention: Observational Cohort

Other

Not applicable - No intervention as this is an observation study

Primary outcomes

  1. Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis

    Time frame: 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.

Secondary outcomes

  1. Visual Acuity (LogMAR)

    Time frame: 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.

  2. Visual Field Mean Deviation (dB)

    Time frame: 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

  3. Colour Vision (Number of Ishihara Plates Correctly Identified)

    Time frame: 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.

  4. Number of Healthcare Consultations Following Optic Neuritis Diagnosis

    Time frame: 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.

  5. Number of Investigations Performed Following Optic Neuritis Diagnosis

    Time frame: 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.

  6. Time to Diagnostic Investigations Following Optic Neuritis Diagnosis (Days)

    Time frame: 12 months

    Time interval (days) from optic neuritis diagnosis to each investigation, reported by investigation type.

  7. Time to Treatment Following Optic Neuritis Diagnosis (Days)

    Time frame: 12 months

    Time interval (Days) from optic neuritis diagnosis to initiation of first treatment course, reported by treatment type.

  8. Number of Treatment Episodes Following Optic Neuritis Diagnosis

    Time frame: 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).

  9. Health-Related Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire [EQ-5D-5L])

    Time frame: 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.

  10. Vision-Related Quality of Life (National Eye Institute Visual Function Questionnaire-25 [NEI-VFQ-25])

    Time frame: 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.

  11. Optic Neuritis-Related Quality of Life (Semi-Structured Questionnaire)

    Time frame: 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

  12. Fatigue (Patient-Reported Outcomes Measurement Information System [PROMIS] Fatigue 6a)

    Time frame: 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).

  13. Depression (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression 4a)

    Time frame: 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).

  14. Work Productivity Loss (Adapted iMTA Productivity Cost Questionnaire [iPCQ])

    Time frame: 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)

  15. Healthcare Resource Utilisation: Appointments, Emergency Department Attendances and Hospital Admissions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])

    Time frame: 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

  16. Healthcare Resource Utilisation: Investigations and Treatment Interventions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])

    Time frame: 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.

  17. Informal Care Received (Hours)

    Time frame: 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.

  18. Out-of-Pocket Costs (Pounds Sterling)

    Time frame: 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)

  19. Knowledge, Attitudes and Practices/Behaviours Regarding Genetic Risk Prediction (KAP Questionnaire)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tasanee Braithwaite, Doctor of Medicine (Oxon)

CONTACT

[email protected]

+44 20 7188 7188

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MS Predictor

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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