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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorKing's College London

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 16 years and above at time of consent

Previous episode of optic neuritis diagnosed at one of the participating sites

Disqualifiers

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

Trial 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)

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • No Intervention: Observational Cohort

    Other intervention

    Not applicable - No intervention as this is an observation study

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Participants Who Have Experienced Optic Neuritis1 intervention

Trial outcomes

Primary outcomes

1

Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis

Occurrence of a diagnosis of multiple sclerosis 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.

Secondary outcomes

1

Visual Acuity (LogMAR)

Visual acuity (LogMAR) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments.

Time frame
From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
2

Visual Field Mean Deviation (dB)

Visual field mean deviation (Decibels) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments

Time frame
From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
3

Colour Vision (Number of Ishihara Plates Correctly Identified)

Colour vision assessed using Ishihara pseudoisochromatic plates and reported as the number of plates correctly identified.

Time frame
From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).
4

Number of Healthcare Consultations Following Optic Neuritis Diagnosis

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College London

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborator

King's College Hospital NHS Trust

Collaborator

Moorfields Eye Hospital NHS Foundation Trust

Collaborator

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