NCT04030403: STOICA

Investigation of the Microbiome of the Cornea in Microbial Keratitis

Completed Last updated 3 January 2023

What this trial tests

trial in Infectious Keratitis in 219 participants. Completed in 1 December 2022.

Timeline

10 September 2019

Primary endpoint
1 August 2022

1 December 2022

Quick facts

Lead sponsor	Liverpool University Hospitals NHS Foundation Trust
Status	Completed
Study type	OBSERVATIONAL
Enrollment	219
Start date	10 September 2019
Primary completion	1 August 2022
Estimated completion	1 December 2022
Sites	1 location across United Kingdom

Conditions studied

• Infectious Keratitis — all drugs for Infectious Keratitis →

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Who can join

18 and older, any sex, with Infectious Keratitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Design: Prospective observational diagnostic study and methods-comparison.

Aims:

The overall aim of the project is to better define the pathogenic microorganisms in patients with microbial keratitis (MK) through a better understanding of the corneal and ocular surface microbiome in health and disease.

This will be achieved through the following objectives:

1. Using NGS, analyse the corneal microbiome of the affected and unaffected eye of patients with and without MK and compare with simultaneous results from CDC and MTPCR.
2. Determine the microbiological spectrum of the cornea, ocular surface and contiguous structures, in patients with MK, healthy controls, contact lens wearers and eye drop users.

Outcome measures:

1. A comparison of isolation rates and identified bacteria obtained from CDC, MTPCR and NGS processing of MK corneal samples will be made.
2. Microorganisms identified in the eyes with MK will be compared to the fellow eye and other control groups and subtractive bioinformatics methodology applied to identify the most likely pathogenic organisms compared to those seen in the healthy corneal and ocular surface microbiome.
3. Comparisons of the relative abundance of microorganisms obtained from MK corneal samples over the participant's follow-up visits will be used to evaluate longitudinal changes in the corneal and ocular surface microbiome during treatment and resolution of MK.
4. A direct comparison between the relative abundance of microorganisms isolated from participants cornea, conjunctiva, eyelids and nose (contiguous structures) will be made to identify any possible endogenous sources of infection for MK.

Population Eligibility:

* All patients aged 18 years and over presenting with unilateral clinically suspected MK to St. Paul's Eye Unit, The Royal Liverpool University Hospital.
* Patients with keratoconus undergoing cross-linking, subjects with no history of MK, subjects with no history of MK who are contact lens wearers and subjects with no history of MK but who are on eye drop treatment for glaucoma.

Duration: Three years.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.