Rapid assessment of infectious keratitis using cytokines and imaging
Official title: Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Run by Johannes Kepler University of Linz · NCT05620264 · Data updated 2026-11-12
This study is testing a new, quick way to diagnose infectious keratitis by looking at tear samples and using advanced imaging to help doctors identify the right treatment faster.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 119 Years |
| Sex | All |
| Enrollment | 392 (estimated) |
| Sponsor | Johannes Kepler University of Linz Academic / other |
| Locations | 1 site (Linz, Upper Austria) |
| Status | Recruiting |
| Started | March 21, 2022 |
| Main results expected | April 30, 2027 |
| Study ends | October 15, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT05620264 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 to 119 who present with untreated keratitis within 10 days of symptom onset.
✕Probably not a fit
Patients with keratitis symptoms lasting more than 10 days or those with severe medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to develop a non-invasive, rapid diagnostic approach for infectious keratitis by evaluating the influence of TNF-alpha on bacterial pathogens and creating an algorithm to distinguish between different types of keratitis-causing pathogens. It utilizes optical coherence tomography (OCT) and tear cytokine analysis to improve diagnostic accuracy and speed compared to traditional methods. The study addresses the limitations of conventional corneal scraping and bacterial culturing, which can be invasive and time-consuming. By analyzing tear samples, the research seeks to enhance understanding of keratitis and facilitate quicker, targeted treatment options.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses of keratitis, improving patient outcomes and treatment efficiency.
How similar studies have gone: Previous small studies have shown promise in using OCT and cytokine analysis for keratitis diagnosis, but this approach is still relatively novel and requires further validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women age of at least 18 years to 119 years * Written informed consent prior to study-related procedures * First presentation with keratitis (corneal epithelial ulceration, corneal edema and/or stromal infiltration with inflammatory cells) within 10 days. * Untreated keratitis or keratitis not responding to the given treatment Exclusion Criteria: Subjects will be excluded if one or more of the following criteria apply: * Symptoms for more than 10 days * Presence or history of a severe medical condition as judged by the clinical investigator * Pregnancy, planned pregnancy or lactating
Where it's running
-
Kepler University Hospital
Linz, Upper Austria, Austria Recruiting
Study contacts
- Principal investigator: Matthias Bolz, MD — JKU Linz
- Study coordinator: Nino D Hirnschall, MD,PhD
- Email: nino.hirnschall@kepleruniklinikum.at
- Phone: 004373278061510
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.