Metagenomics for Ocular Inflammation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMoorfields Eye Hospital NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindication to ocular fluid sampling

Where an urgent result within 5 days is clinically required

Trial population

Patients in the UK attending Moorfields Eye Hospital, London.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Metagenomic sequencing of aqueous humor

    Diagnostic test

    Metagenomic Sequencing on aqueous humor surplus to diagnostic requirements

  • Ocular Imaging

    Diagnostic test

    Ocular imaging with anterior segment OCT, laser flare photometry, confocal microscopy and colour fundus photography.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Patients with ocular inflammation presumed to be infectious or para-infectious2 interventions

Trial outcomes

Primary outcomes

1

The percentage of participants who receive a clinically viable result from metagenomic sequencing

Time frame
12 months

Secondary outcomes

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

Other outcomes

Sponsors and contacts

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

Moorfields Eye Hospital NHS Foundation Trust

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborator