Investigation of the Microbiome of the Cornea in Microbial Keratitis

NCT04030403 | Completed

• 1 other identifier: 5680
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Infectious Keratitis

Keywords

next-generation sequencing; metagenomics; microorganism targeted polymerase chain reaction; conventional diagnostic culture; corneal impression membrane

Outcome Measures

Primary Outcomes (1)

• Differences in microorganisms identified between the affected eyes of microbial keratitis participants and control eyes.

  Microorganisms identified in the eyes with MK will be compared to the control 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 microbiome.

  3 years

Secondary Outcomes (3)

• Differences in microorganisms identified using the three processing methods (conventional diagnostic culture, microorganism targeted PCR and next-generation sequencing)

  3 years

• Longitudinal changes of the relative abundance of microorganisms in microbial keratitis

  3 years

• Identification of endogenous sources of infection for microbial keratitis

  3 years

Study Arms (5)

Microbial Keratitis participants

151 participants presenting with clinically suspected microbial keratitis will be recruited from St Paul's Eye Unit, Royal Liverpool University Hospital.

Healthy control participants

20 participants with no history of microbial keratitis who use no eye drop medication will be recruited.

Contact-lens wearers

20 participants with no history of microbial keratitis who are contact-lens wearers will be recruited.

Glaucoma eye drop users

20 participants who have no history of microbial keratitis but are on eye drop treatment for glaucoma. This group has been included to assess for changes in the corneal microbiome that could be secondary to drop treatment.

Keratoconus participants

30 participants with keratoconus who are undergoing cross-linking will be recruited. These participants as part of the routine cross-linking procedure will have their corneal epithelium removed. This removed epithelium from an otherwise healthy corneal surface will allow for a direct comparison between the corneal microbiome characterised from the corneal impression membrane and that characterised directly from the epithelium.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The microbial keratitis participants presenting eye will be examined using a slit-lamp biomicroscope to assess for the presence of clinically suspected microbial keratitis. A history will be obtained from the control participants and both eyes examined using a slit-lamp biomicroscope.

You may qualify if:

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

You may not qualify if:

• Patients who are unable to give their informed consent.
• Patients under the age of 18 years.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead
• University of Liverpool: collaborator

Study Sites (1)

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L18 8TX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Corneal impression membrane samples obtained from the eyes of participants Conjunctiva, eyelid and nasal swabs

Study Officials

• Stephen Kaye, MD

  Royal Liverpool University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 24, 2019
• Study Start: September 10, 2019
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 3, 2023

Record last verified: 2022-06

Locations

GB (1)