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

July 9, 2026 updated by: 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust
        • Contact:
          • Neringa Jurkute, MD, PhD, FEBOphth
          • Phone Number: +44 20 7253 3411
          • Email: n.jurkute@nhs.net
        • Principal Investigator:
          • Neringa Jurkute, MD, PhD, FEBOphth
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • James McHugh, FRCOphth
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Tasanee Braithwaite, FRCOphth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: No Intervention: Observational Cohort
Not applicable - No intervention as this is an observation study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Extracted from retrospective record at baseline, and reviewed before study end to capture any new events occurring during the 12 month study period.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
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
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)
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.
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
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.
12 months
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.
12 months
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.
12 months
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.
12 months
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).
12 months
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.
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])
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.
Baseline and repeated 3-12 months later
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
Measured at baseline recruitment and repeated 3-12 months later
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).
Baseline recruitment and repeated once 3-12 months later
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).
Baseline recruitment and repeated once 3-12 months later
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)
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])
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
Baseline recruitment and repeated once 3-12 months later
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.
Baseline recruitment and repeated once 3-12 months later
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.
Baseline recruitment and repeated once 3-12 months later
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)
Baseline recruitment and repeated once 3-12 months later
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.
Baseline recruitment and repeated at 3-12 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College Hospital NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Moorfields Eye Hospital NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tasanee Braithwaite, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 352834
  • 222 (Other Grant/Funding Number: MS Society UK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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