WithdrawnNot Applicable

Diagnosing Corneal Infection

Stopped: Study did not start due to COVID and long term staff sickness

United Kingdom0Started 2025-02-01

Plain-language summary

Microbial keratitis is a common and serious eye disease in Edinburgh. Prompt treatment with antibiotics can prevent sight loss, and identification of the micro-organism and its antibiotic sensitivities are key to appropriate management. Standard practice of collecting infected material from the cornea using a blade can be distressing and time-consuming. Corneal impression membranes (CIM) have recently been introduced to another National Health Service (NHS) eye unit (St Paul's Eye Unit, Liverpool) as they detect more micro-organisms and are more patient-friendly than corneal scrape. The aim of this study is to compare CIM with reference to current standard practice of corneal scrape. If CIM have greater sensitivity and fewer adverse events than scrape then the investigators will consider using CIM instead of scrape in routine clinical care. The investigators will also collect additional CIM to help develop new microbiological tests being developed at the University of Edinburgh, which if successful could be applied to CIM at the bedside to further improve the speed of diagnosis in the future. Development of the new microbiological tests is facilitated by having samples of germs from eye infections. Study design: cross-sectional study comparing diagnostic techniques Participants: recruited from the Acute referral clinic at the Princess Alexandra Eye Pavilion, or emergency on-call ophthalmology service What is involved: subjects with microbial keratitis will have standard investigations to identify the germ causing the infection. In addition the investigators will capture germs using CIM, and will compare CIM with the standard test to see which is better. Funding: departmental funding

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients 18 years old or older * Appearances typical of a new bacterial, fungal or acanthamoeba infection of the cornea, in one or both eyes * Able to give informed consent Exclusion Criteria: * Patients who don't give consent * Patients who would not normally have a corneal scrape as part of routine care. This includes patients with viral rather than bacterial corneal infection, such as herpetic keratitis. * Patients with corneal perforation or descemetocele

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT04230811

SponsorUniversity of Edinburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-31

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