Microbial Keratitis Sampling for Biomarker Discovery

NCT05888883 | Completed

• 1 other identifier: 2023/0017
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to identify prognostic and/or diagnostic signatures (biomarkers) related to microbial keratitis outcomes. We will compare tear and ocular swab samples from participants currently suffering from microbial keratitis to healthy control participants. The primary study objective is to undertake analysis (proteomics and metabolomics) of microbial keratitis patient (and healthy control) ocular samples collected throughout the patient treatment course to better understand the ocular microenvironment and to identify candidate biomarkers for future targeted screening and validation studies. The secondary study objective is to define the microorganisms in patients with microbial keratitis through a better understanding of the ocular surface micro/mycobiome (the resident bacteria and fungi) in health and disease Participants will have their tears collected via capillary tube during their treatment course, and swabs of their conjunctiva collected at their first and final appointments.

Conditions

Microbial Keratitis

Outcome Measures

Primary Outcomes (2)

• Globally measure, list and compare the peptides extracted from ocular tear samples of participants with and without the disease (microbial keratitis) throughout the infection course.

  Identify any proteomic signatures of disease prognosis

  5 years

• Globally measure, list and compare the metabolites extracted from ocular tear samples of participants with and without the disease (microbial keratitis) throughout the infection course.

  Identify any metabolomic signatures of disease prognosis

  5 years

Secondary Outcomes (1)

• Measure, list and compare microorganisms (bacteria and fungi) extracted from ocular swab samples of participants with and without the disease (microbial keratitis)

  5 years

Study Arms (2)

Microbial Keratitis Participants

Up to 50 participants presenting with clinically suspected microbial keratitis will be recruited from the Princess Alexandra Eye Pavilion, NHS Lothian, Edinburgh

Healthy Control Participants

Up to 20 participants with no history of microbial keratitis will be recruited.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants with suspected microbial keratitis will be recruited and consented at their first presentation at the Ophthalmology Acute Referral Clinic, or on-call service at the Princess Alexandra Eye Pavilion, Edinburgh, UK. Healthy control volunteer participants will be recruited from the University of Edinburgh by email invitation or by word-of-mouth

You may qualify if:

• years old or older.
• Able to provide informed consent for themselves.
• Patient group: Appearances typical of a new infective keratitis of the cornea, in one eye only.
• Control group: healthy volunteers with no recent history (within 1 year) of MK or inflammatory eye condition.

You may not qualify if:

• \<16 years old.
• Not able to provide consent for themselves.
• Patients with suspected viral rather than bacterial/fungal corneal infection, such as herpetic keratitis.
• Patients who present with MK in both eyes.
• Control group: Individuals receiving topical steroid or antimicrobial therapy to the eye, or any other form of systemic immunosuppression/antimicrobial drug.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Princess Alexandra Eye Pavilion (NHS Lothian)

Edinburgh, Scotland, EH3 9HA, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be retained. Swab samples will undergo DNA extraction, amplification and sequencing for pathogens (bacterial and fungal) present within the sample. No human DNA will be studied.

Study Officials

• Naing Latt Tint, FRCOphth

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

GB (1)