Metagenomics for Ocular Inflammation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metagenomic sequencing of aqueous humor, Ocular Imaging.
- Who it may be relevant to
- Registry conditions: Uveitis, Aqueous Humor, Infection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Metagenomic Sequencing of Ocular Fluids in Patients With Ocular Inflammation
Overview
The aim of this study is to apply a diagnostic test called 'metagenomic sequencing' to identify the involvement of potential infections in patients with ocular inflammation, where this hasn't been detected by currently available standard testing. For many people with ocular inflammation, no cause is ever found for their disease. In some cases, an infection or infectious trigger is suspected, but currently available tests are inadequate. Metagenomic sequencing can identify almost every globally known infection (bacteria, virus, fungi, parasites) in a sample. Therefore, it has the potential to identify an infection that has caused or triggered ocular inflammation, and as a consequence may help to identify specific treatments. It has the potential to improve our understanding of how to diagnose and treat people with this problem. This study will allow us to test the technique that has been previously optimised for brain infections, on ocular fluids. Participants will be 18 years of age or over and have active ocular inflammation which is suspected to be due to an infection, or an autoimmune process which has been triggered by an infection, but identification of this infection has not been possible using the investigations available as part of standard NHS care. Participants will be identified by the treating clinical team as requiring a sample of fluid from inside of the eye, and some of this fluid will be sent for metagenomic sequencing alongside standard testing. This study will be conducted at Moorfields Eye Hospital, London and will last for approximately a year. Participants will undergo additional non-invasive ocular imaging on the day of their clinic visit, but will not have to attend any additional research visits.
Interventions
- Diagnostic test Metagenomic sequencing of aqueous humor
Metagenomic Sequencing on aqueous humor surplus to diagnostic requirements - Diagnostic test Ocular Imaging
Ocular imaging with anterior segment OCT, laser flare photometry, confocal microscopy and colour fundus photography.
Primary outcome measures
- The percentage of participants who receive a clinically viable result from metagenomic sequencing [Time frame: 12 months]
Secondary outcome measures (1)
- The number of patients who receive a result that leads to a change in treatment and beneficial outcome from metagenomic sequencing [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 18 years of age or older with the capacity to consent
- Standard of care has not determined a clinical diagnosis
- Active ocular inflammation with risk of visual loss
- Clinically suspected infectious or para-infectious cause of ocular inflammation
Exclusion criteria
- Contraindication to ocular fluid sampling
- Where an urgent result within 5 days is clinically required
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United Kingdom · 1 center
- Moorfields Eye Hospital NHS Foundation Trust — London
Publications
- Atkinson L, Lee JC, Lennon A, Shah D, Storey N, Morfopoulou S, Harris KA, Breuer J, Brown JR. Untargeted metagenomics protocol for the diagnosis of infection from CSF and tissue from sterile sites. Heliyon. 2023 Sep 9;9(9):e19854. doi: 10.1016/j.heliyon.2023.e19854. eCollection 2023 Sep. PMID 37809666
- Penner J, Hassell J, Brown JR, Mankad K, Storey N, Atkinson L, Ranganathan N, Lennon A, Lee JCD, Champsas D, Kopec A, Shah D, Venturini C, Dixon G, De S, Hatcher J, Harris K, Aquilina K, Kusters MA, Moshal K, Shingadia D, Worth AJJ, Lucchini G, Merve A, Jacques TS, Bamford A, Kaliakatsos M, Breuer J, Morfopoulou S. Translating metagenomics into clinical practice for complex paediatric neurological PMID 37557958
- Doan T, Acharya NR, Pinsky BA, Sahoo MK, Chow ED, Banaei N, Budvytiene I, Cevallos V, Zhong L, Zhou Z, Lietman TM, DeRisi JL. Metagenomic DNA Sequencing for the Diagnosis of Intraocular Infections. Ophthalmology. 2017 Aug;124(8):1247-1248. doi: 10.1016/j.ophtha.2017.03.045. Epub 2017 May 16. No abstract available. PMID 28526549
Identifiers
NCT: NCT06974162 · CHUC1004 · 25/WM/0072 · 354543