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

NCT07704294 | Not Yet Recruiting

• 2 other identifiers: 352834222
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.Incident diagnosis of MS following a first episode of optic neuritis, including time to MS diagnosis.
2. 2.Visual outcomes following optic neuritis, including visual acuity, visual field, and colour vision.
3. 3.Clinical care received following optic neuritis, including specialist review, investigations/tests
4. 4.Health-related and vision-related quality of life.
5. 5.Health economic impacts and healthcare utilisation after experiencing optic neuritis
6. 6.Knowledge, attitudes, and practices/behaviours about using genetic information to predict future MS disease risk.
7. 7.Allow researchers to review information from their medical records relating to their optic neuritis diagnosis, investigations, treatments, and outcomes.
8. 8.Be invited to provide a saliva sample for genetic analysis.
9. 9.Complete questionnaires about their lifestyle/risk factors, quality of life, and views on genetic risk prediction.
10. 10.Allow researchers to track long-term health outcomes using information from their NHS records

Conditions

Optic Neuritis; Multiple Sclerosis; Neuromyelitis Optica Spectrum Disorder; Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders; Sarcoid

Keywords

Optic neuritis; Multiple sclerosis; MS; Genetic Risk Score; Risk Prediction; Myelin Oligodendrocyte Glycoprotein; MOG Antibody Disease; Neuromyelitis Optica Spectrum Disorder

Outcome Measures

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.

  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 (19)

• Visual Acuity (LogMAR)

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

• Visual Field Mean Deviation (dB)

  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)

  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

  12 months

• Number of Investigations Performed Following Optic Neuritis Diagnosis

  12 months

Study Arms (1)

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

Interventions

No Intervention: Observational Cohort OTHER

Not applicable - No intervention as this is an observation study

Participants Who Have Experienced Optic Neuritis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Aged 16 years and above at time of consent
• Previous episode of optic neuritis diagnosed at one of the participating sites

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• King's College Hospital NHS Trust: collaborator
• Moorfields Eye Hospital NHS Foundation Trust: collaborator

Study Sites (3)

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 36932161 BACKGROUND

• 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.

  PMID: 32200476 BACKGROUND

• 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.

  PMID: 38867071 BACKGROUND

• 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.

  PMID: 31740484 BACKGROUND

• 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.

  PMID: 33017023 BACKGROUND

• 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.

  PMID: 38418465 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

Optic Neuritis; Multiple Sclerosis; Neuromyelitis Optica; Sarcoidosis; Genetic Risk Score

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tasanee Braithwaite

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tasanee Braithwaite, Doctor of Medicine (Oxon)

CONTACT

+44 20 7188 7188; tasanee.braithwaite@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-06

Locations

GB (3)