Diagnosing Corneal Infection

NCT04230811 | Withdrawn

• 1 other identifier: AC19051
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Corneal Ulcer (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  Sensitivity of corneal membrane to detect microbes, compared to corneal scrape

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Adverse events

  through study completion, an average of 1 year

Interventions

Corneal impression membrane (Millicell Cell Culture Insert, 12mm, hydrophilic PTFE 0.4µm (PICM01250)) DIAGNOSTIC_TEST

Application of corneal membrane to the cornea for 3-5 seconds, after anaesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the Princess Alexandra Eye Pavilion in Edinburgh, who are given a clinical diagnosis of microbial keratitis in one or both eyes

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 26377412 BACKGROUND

• 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.

  PMID: 29861935 BACKGROUND

• 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.

  PMID: 30355797 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Microbes isolated from corneal ulcers will be retained for future testing

MeSH Terms

Conditions

Corneal Ulcer; Disease

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ian MacCormick, MBChB PhD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 18, 2020
• Study Start: February 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)