Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment

NCT05620264 | Unknown

• 1 other identifier: KUK-Ophthalmology-002
• Study Type: observational
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

As conventional corneal scraping with bacterial culturing has several disadvantages such as long duration until diagnosis, invasiveness and lacks alternatives, there is demand for a novel non-invasive, rapid test in keratitis management. First aim of this study will be to evaluate the influence of TNF-alpha on Gram+ and Gram- bacteria causing keratitis. Second aim of this study will be to develop an algorithm, that should help to distinguish between different pathogens causing keratitis.

Conditions

Keratitis Bacterial; Keratitis Fungal

Keywords

Keratitis; Optical Coherence Tomography; Cytokine Quantification; Tear Film

Outcome Measures

Primary Outcomes (1)

• TNF Alpha in Tear Film

  Comparison of TNF-alpha level differences in tear film between Gram+ and Gram- bacteria causing keratitis

  The measurement is assessed at the point of study inclusion.

Secondary Outcomes (2)

• Interleukins

  The measurement is assessed at the point of study inclusion.

• Anterior segment Optical Coherence Tomography

  The measurement is assessed at the point of study inclusion

Study Arms (1)

Keratitis Group

Patients with clinically suspected bacterial or fungal keratitis

Diagnostic Test: Tear Sample Probe

Interventions

Tear Sample Probe DIAGNOSTIC_TEST

Samples will be collected by conjunctival lavage of the affected eye without topical anesthesia. Sterile normal saline will be infused at room temperature into the lower conjunctival sac by gently pulling down the lower eyelid and with a needle-free insulin syringe. After few seconds, the lavage fluid will be aspirated back into the same syringe without the syringe touching the conjunctiva.

Keratitis Group

Eligibility Criteria

• Age: 18 Years - 119 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from the ambulances of Kepler University clinic, ophthalmology, Linz, Austria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Kepler University of Linz: lead

Study Sites (1)

Kepler University Hospital

Linz, Upper Austria, 4021, Austria

RECRUITING

Related Publications (13)

• Ting DSJ, Ho CS, Deshmukh R, Said DG, Dua HS. Infectious keratitis: an update on epidemiology, causative microorganisms, risk factors, and antimicrobial resistance. Eye (Lond). 2021 Apr;35(4):1084-1101. doi: 10.1038/s41433-020-01339-3. Epub 2021 Jan 7.

  PMID: 33414529 BACKGROUND

• Konstantopoulos A, Cendra MDM, Tsatsos M, Elabiary M, Christodoulides M, Hossain P. Morphological and cytokine profiles as key parameters to distinguish between Gram-negative and Gram-positive bacterial keratitis. Sci Rep. 2020 Nov 18;10(1):20092. doi: 10.1038/s41598-020-77088-w.

  PMID: 33208864 BACKGROUND

• Konstantopoulos A, Del Mar Cendra M, Tsatsos M, Elabiary M, Christodoulides M, Hossain P. Author Correction: Morphological and cytokine profiles as key parameters to distinguish between Gram-negative and Gram-positive bacterial keratitis. Sci Rep. 2021 Feb 26;11(1):5168. doi: 10.1038/s41598-021-85007-w. No abstract available.

  PMID: 33637814 BACKGROUND

• Chodosh J, Astley RA, Butler MG, Kennedy RC. Adenovirus keratitis: a role for interleukin-8. Invest Ophthalmol Vis Sci. 2000 Mar;41(3):783-9.

  PMID: 10711694 BACKGROUND

• Peng L, Zhong J, Xiao Y, Wang B, Li S, Deng Y, He D, Yuan J. Therapeutic effects of an anti-IL-6 antibody in fungal keratitis: Macrophage inhibition and T cell subset regulation. Int Immunopharmacol. 2020 Aug;85:106649. doi: 10.1016/j.intimp.2020.106649. Epub 2020 Jun 5.

  PMID: 32504999 BACKGROUND

• Vasanthi M, Prajna NV, Lalitha P, Mahadevan K, Muthukkaruppan V. A pilot study on the infiltrating cells and cytokine levels in the tear of fungal keratitis patients. Indian J Ophthalmol. 2007 Jan-Feb;55(1):27-31. doi: 10.4103/0301-4738.29491.

  PMID: 17189883 BACKGROUND

• Zhang Y, Liang Q, Liu Y, Pan Z, Baudouin C, Labbe A, Lu Q. Expression of cytokines in aqueous humor from fungal keratitis patients. BMC Ophthalmol. 2018 Apr 19;18(1):105. doi: 10.1186/s12886-018-0754-x.

  PMID: 29673332 BACKGROUND

• Azher TN, Yin XT, Stuart PM. Understanding the Role of Chemokines and Cytokines in Experimental Models of Herpes Simplex Keratitis. J Immunol Res. 2017;2017:7261980. doi: 10.1155/2017/7261980. Epub 2017 Apr 9.

  PMID: 28491875 BACKGROUND

• Wang L, Wang R, Xu C, Zhou H. Pathogenesis of Herpes Stromal Keratitis: Immune Inflammatory Response Mediated by Inflammatory Regulators. Front Immunol. 2020 May 13;11:766. doi: 10.3389/fimmu.2020.00766. eCollection 2020.

  PMID: 32477330 BACKGROUND

• Song XJ, Li DQ, Farley W, Luo LH, Heuckeroth RO, Milbrandt J, Pflugfelder SC. Neurturin-deficient mice develop dry eye and keratoconjunctivitis sicca. Invest Ophthalmol Vis Sci. 2003 Oct;44(10):4223-9. doi: 10.1167/iovs.02-1319.

  PMID: 14507865 BACKGROUND

• Cole N, Bao S, Willcox M, Husband AJ. Expression of interleukin-6 in the cornea in response to infection with different strains of Pseudomonas aeruginosa. Infect Immun. 1999 May;67(5):2497-502. doi: 10.1128/IAI.67.5.2497-2502.1999.

  PMID: 10225913 BACKGROUND

• Cole N, Krockenberger M, Stapleton F, Khan S, Hume E, Husband AJ, Willcox M. Experimental Pseudomonas aeruginosa keratitis in interleukin-10 gene knockout mice. Infect Immun. 2003 Mar;71(3):1328-36. doi: 10.1128/IAI.71.3.1328-1336.2003.

  PMID: 12595449 BACKGROUND

• Diamond J, Leeming J, Coombs G, Pearman J, Sharma A, Illingworth C, Crawford G, Easty D. Corneal biopsy with tissue micro-homogenisation for isolation of organisms in bacterial keratitis. Eye (Lond). 1999 Aug;13 ( Pt 4):545-9. doi: 10.1038/eye.1999.135.

  PMID: 10692928 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tear Film

MeSH Terms

Conditions

Keratitis

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Matthias Bolz, MD

  JKU Linz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nino D Hirnschall, MD,PhD

CONTACT

004373278061510; nino.hirnschall@kepleruniklinikum.at

Haidar Khalil, MD

CONTACT

004373278061510; haidar.khalil@kepleruniklinikum.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: November 17, 2022
• Study Start: March 21, 2022
• Primary Completion: April 30, 2024
• Study Completion: October 15, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

AU (1)