NCT05620264|Unknown
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
VICTORIA
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VICTORIA
Sponsor study identifier
observational
392
1 country
1
Study Start
March 21, 2022
Actual (reported)Primary Completion
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
March 21, 2022
Actual (reported)October 5, 2022
Actual (reported)November 17, 2022
Actual (reported)April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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
Patients with clinically suspected bacterial or fungal keratitis
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The participants will be recruited from the ambulances of Kepler University clinic, ophthalmology, Linz, Austria
Kepler University Hospital
Linz, Upper Austria, 4021, Austria
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.
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.
Tear Film
Matthias Bolz, MD
JKU Linz
First Submitted
October 5, 2022
First Posted
November 17, 2022
Study Start
March 21, 2022
Actual (reported)Primary Completion
April 30, 2024
Estimated (date passed)Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 13, 2023
Record last verified: 2023-10
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