NCT04230811|Withdrawn
Study Stopped
Study did not start due to COVID and long term staff sickness
Diagnosing Corneal Infection
Diagnosis of Microbial Keratitis Using Corneal Impression Membrane
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Study did not start due to COVID and long term staff sickness
Diagnosis of Microbial Keratitis Using Corneal Impression Membrane
Sponsor study identifier
observational
0
1 country
1
Study Start
February 1, 2025
Actual (reported)Primary Completion
October 31, 2025
Actual (reported)Study Completion
October 31, 2025
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 9, 2020
Actual (reported)January 18, 2020
Actual (reported)February 1, 2025
Actual (reported)October 31, 2025
Actual (reported)October 31, 2025
Actual (reported)Sensitivity
Sensitivity of corneal membrane to detect microbes, compared to corneal scrape
through study completion, an average of 1 year
Adverse events
through study completion, an average of 1 year
Application of corneal membrane to the cornea for 3-5 seconds, after anaesthesia
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients attending the Princess Alexandra Eye Pavilion in Edinburgh, who are given a clinical diagnosis of microbial keratitis in one or both eyes
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Kaye S, Sueke H, Romano V, Chen JY, Carnt N, Tuft S, Neal T. Impression membrane for the diagnosis of microbial keratitis. Br J Ophthalmol. 2016 May;100(5):607-10. doi: 10.1136/bjophthalmol-2015-307091. Epub 2015 Sep 16.
Akram AR, Avlonitis N, Lilienkampf A, Perez-Lopez AM, McDonald N, Chankeshwara SV, Scholefield E, Haslett C, Bradley M, Dhaliwal K. A labelled-ubiquicidin antimicrobial peptide for immediate in situ optical detection of live bacteria in human alveolar lung tissue. Chem Sci. 2015 Dec 1;6(12):6971-6979. doi: 10.1039/c5sc00960j. Epub 2015 Jun 29.
Microbes isolated from corneal ulcers will be retained for future testing
Ian MacCormick, MBChB PhD
University of Edinburgh
0 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2020
First Posted
January 18, 2020
Study Start
February 1, 2025
Actual (reported)Contact the study team to confirm eligibility.
Akram AR, Chankeshwara SV, Scholefield E, Aslam T, McDonald N, Megia-Fernandez A, Marshall A, Mills B, Avlonitis N, Craven TH, Smyth AM, Collie DS, Gray C, Hirani N, Hill AT, Govan JR, Walsh T, Haslett C, Bradley M, Dhaliwal K. In situ identification of Gram-negative bacteria in human lungs using a topical fluorescent peptide targeting lipid A. Sci Transl Med. 2018 Oct 24;10(464):eaal0033. doi: 10.1126/scitranslmed.aal0033.
Primary Completion
October 31, 2025
Actual (reported)Study Completion
October 31, 2025
Actual (reported)Last Updated
February 27, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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