Rapid assessment of infectious keratitis using cytokines and imaging
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
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 |
|---|---|
| Enrollment | 392 (estimated) |
| Ages | 18 Years to 119 Years |
| Sex | All |
| Sponsor | Johannes Kepler University of Linz Academic / other |
| Locations | 1 site (Linz, Upper Austria) |
| Trial ID | NCT05620264 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 119 who present with untreated keratitis within 10 days of symptom onset.
Not a fit: Patients with keratitis symptoms lasting more than 10 days or those with severe medical conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Linz, Upper Austria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.