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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNot applicable - No intervention as this is an observation study
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Visual Acuity (LogMAR)
Visual acuity (LogMAR) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments.
Visual Field Mean Deviation (dB)
Visual field mean deviation (Decibels) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments
Colour Vision (Number of Ishihara Plates Correctly Identified)
Colour vision assessed using Ishihara pseudoisochromatic plates and reported as the number of plates correctly identified.
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.
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
This trial is not recruiting at the moment. You can still explore other options: