Keratitis BacterialVICTORIANCT05620264
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
An observational study of Keratitis Bacterial and Keratitis Fungal, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 119 years
- Conditions the study is for
- Keratitis Bacterial, Keratitis Fungal
- What is being tested?
- Tear Sample Probe
- Type of treatment
- Injection or infusion
- How many people
- 392 participants
- Where
- 1 siteAustria
- Study dates
- 21 Mar 2022to 15 Oct 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 119 years
- All sexes
- Adult, Older adult
Study population: The participants will be recruited from the ambulances of Kepler University clinic, ophthalmology, Linz, Austria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Kepler University Hospital
Linz, Upper Austria, 4021
Haidar Khalil, MD, 0043 5768083 ext. 73425, haidar.khalil@kepleruniklinikum.at
Nino Hirnschall, MD, 0043 5768083 ext. 73425, nino.hirnschall@kepleruniklinikum.at
About this study
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.
Read the detailed description
Infectious or inflammatory processes of the cornea (keratitis) are common and vision threatening. They are the 5th leading cause of blindness and especially infectious keratitis is responsible for 2,000,000 new blind eyes per year (worldwide). Commonly, the presence and nature of bacterial pathogens is determined by taking scratches from the cornea, subsequent Gram stain and examination of microbiological cultures. Major problems in therapeutic decision-making pose the long duration of bacterial culturing for pathogen detection (approximately one week), relatively low sensitivity and increasingly frequent bacterial resistances to antibiotic agents.
In small previous studies optical coherence tomography (OCT) combined with analysis of tear cytokines were found to be supportive in distinguishing between different pathogens causing keratitis. These studies appear to be a game changer in the field of rapid testing for keratitis. However, the problem of these studies is a small sample size and the use of partially outdated equipment.
Benefit/risk assessment Although there is no direct benefit for participating subjects, the results of the study can help to gain more insight into the course of keratitis and could further improve the diagnostic utilities in disease management.
There is no additional medication used in this study. The findings of the present study could help to establish a better understanding of keratitis and could enable faster and target-oriented therapy. All applied measurement techniques are painfree.
Thus, the risk to benefit ratio seems to be acceptable.
Study objectives
Primary:
- Comparison of TNF-alpha level differences in tear film (pg/ml) between Gram+ and Gram- bacteria causing keratitis (z test for non-paired samples).
Secondary:
- To develop an algorithm, that should help to distinguish between different pathogens causing keratitis using cytokine levels and OCT findings. This part of the study will be experimental (partial least squares regression and regression random forest plots)
- Levels of IL-1alpha, IL-1beta, IL-6, IL-8, IL-10, IL-17A, TNF-alpha in keratitis
- Morphological findings in optical coherence tomography: corneal thickness (µm), infiltrate thickness (µm), reflectivity of the infiltrate (grey level, where 0 is black and 255 is white).
Design: Prospective single center trial The participants will be recruited from the ambulances of Kepler University clinic, ophthalmology, Linz, Austria A total of 392 patients will be included in this study. Aimed power: 0.8 significance level after a Bonferroni correction for 7 explanatory variables (7 different cytokines): 0.07 Used values (TNF alpha 2): Group 1: 18.8 (26.36) and Group 2: 50.12 (103.83) Parameters Results Power 0.800 alpha 0.007 Mean (Group 1) 18.8 Mean (Group 2) 50.12 Std. deviation (Group 1) 26.36 Std. deviation (Group 2) 103.83 Sample size 1 146 Sample size 2 146 Power (obtained) 0.798 For correction of a potential rounding error (calculated power 0.798) one case should be added to each group.
Although there will not be any study follow-ups the investigator still expects a drop-out rate of 30% for the following reason: As published previously, 67% of all corneal biopsies result in a positive culture. 13 In those cases, where the culture does not provide positive results, the patient will have to be excluded from the analysis.
Therefore, the investigator will include 147 + 147 + (147+147)*0.33 = 391.02 eyes -> 392 eyes Analysis of data is only possible, if the corneal biopsy is positive (a pathogen causing the keratitis is found). Therefore, the investigator expects that approximately 30% of the patients will not be included for analysis. In these cases, the OCT images will still be evaluated, but the tear film sample will be either disposed according to the protocol of tissue waste or if the investigating ophthalmologist expects a non-infectious type of keratitis (such as a neurotrophic ulcer) the cytokine quantification will be performed.
Measurement techniques CASIA 2 (Tomey, Japan) is a ss-OCT biometer that allows high resolution imaging of the anterior segment of the eye.
Tear sampling and cytokine analysis 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. Afterwards, the sample will be stored at -80° Celsius until all samples are collected. As mentioned in those samples, where the corneal biopsy was negative, will either be disposed, or (if the ophthalmology expects a non-infectious type of keratitis) still be analysed. Therefore, the conjunctival fluid from the syringes will be pooled and spun down in a centrifuge (400xg for 10 min at 4°C). The Supernatants will be analyzed using the pro-inflammatory multiplex assay kit from Meso Scale Discovery (Gaithersburg, MD, USA) for levels of the following cytokines and chemokines: IL-1alpha, IL-1beta, IL-6, IL-8, IL-10, IL-17A, TNF-alpha. Eighty samples will be analysed at the same time.
- Conditions
- Keratitis Bacterial, Keratitis Fungal
- Being tested
- Tear Sample Probe
- Keywords
- Keratitis, Optical Coherence Tomography, Cytokine Quantification, Tear Film
- Medical subject headings
- Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear Sample ProbeDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Keratitis Group | Patients with clinically suspected bacterial or fungal keratitis Receives: Diagnostic Test: Tear Sample Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF Alpha in Tear Film
Comparison of TNF-alpha level differences in tear film between Gram+ and Gram- bacteria causing keratitis
Measured: The measurement is assessed at the point of study inclusion.
Secondary outcomes (2)
Interleukins
Levels of IL-1alpha, IL-1beta, IL-6, IL-8, IL-10, IL-17A
Measured: The measurement is assessed at the point of study inclusion.
Anterior segment Optical Coherence Tomography
Morphological findings in optical coherence tomography: corneal thickness, infiltrate thickness, reflectivity of the infiltrate
Measured: The measurement is assessed at the point of study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start21 Mar 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Keratitis BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 392 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Bolz, MD, Principal investigator, JKU Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620264
- Sponsor's protocol ID
- KUK-Ophthalmology-002
- Acronym
- VICTORIA
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If IPD is going to be shared, is still in evaluation and will be decided throughout the study.
Publications
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.
PubMed 33414529Konstantopoulos 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.
PubMed 33208864Konstantopoulos 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.
PubMed 33637814Chodosh J, Astley RA, Butler MG, Kennedy RC. Adenovirus keratitis: a role for interleukin-8. Invest Ophthalmol Vis Sci. 2000 Mar;41(3):783-9.
PubMed 10711694Peng 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.
PubMed 32504999Vasanthi 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.
PubMed 17189883Zhang 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.
PubMed 29673332Azher 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.
PubMed 28491875Wang 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.
PubMed 32477330Song 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.
PubMed 14507865Cole 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.
PubMed 10225913Cole 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.
PubMed 12595449Diamond 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.
PubMed 10692928
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
- ClinicalTrials.gov ID
- NCT05620264
- Acronym / sponsor ID
- VICTORIA / KUK-Ophthalmology-002
- Conditions
- Keratitis Bacterial, Keratitis Fungal
- Keywords
- Keratitis, Optical Coherence Tomography, Cytokine Quantification, Tear Film
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Infectious or inflammatory processes of the cornea (keratitis) are common and vision threatening. They are the 5th leading cause of blindness and especially infectious keratitis is responsible for 2,000,000 new blind eyes per year (worldwide). Commonly, the presence and nature of bacterial pathogens is determined by taking scratches from the cornea, subsequent Gram stain and examination of microbiological cultures. Major problems in therapeutic decision-making pose the long duration of bacterial culturing for pathogen detection (approximately one week), relatively low sensitivity and increasingly frequent bacterial resistances to antibiotic agents.
In small previous studies optical coherence tomography (OCT) combined with analysis of tear cytokines were found to be supportive in distinguishing between different pathogens causing keratitis. These studies appear to be a game changer in the field of rapid testing for keratitis. However, the problem of these studies is a small sample size and the use of partially outdated equipment.
Benefit/risk assessment Although there is no direct benefit for participating subjects, the results of the study can help to gain more insight into the course of keratitis and could further improve the diagnostic utilities in disease management.
There is no additional medication used in this study. The findings of the present study could help to establish a better understanding of keratitis and could enable faster and target-oriented therapy. All applied measurement techniques are painfree.
Thus, the risk to benefit ratio seems to be acceptable.
Study objectives
Primary:
- Comparison of TNF-alpha level differences in tear film (pg/ml) between Gram+ and Gram- bacteria causing keratitis (z test for non-paired samples).
Secondary:
- To develop an algorithm, that should help to distinguish between different pathogens causing keratitis using cytokine levels and OCT findings. This part of the study will be experimental (partial least squares regression and regression random forest plots)
- Levels of IL-1alpha, IL-1beta, IL-6, IL-8, IL-10, IL-17A, TNF-alpha in keratitis
- Morphological findings in optical coherence tomography: corneal thickness (µm), infiltrate thickness (µm), reflectivity of the infiltrate (grey level, where 0 is black and 255 is white).
Design: Prospective single center trial The participants will be recruited from the ambulances of Kepler University clinic, ophthalmology, Linz, Austria A total of 392 patients will be included in this study. Aimed power: 0.8 significance level after a Bonferroni correction for 7 explanatory variables (7 different cytokines): 0.07 Used values (TNF alpha 2): Group 1: 18.8 (26.36) and Group 2: 50.12 (103.83) Parameters Results Power 0.800 alpha 0.007 Mean (Group 1) 18.8 Mean (Group 2) 50.12 Std. deviation (Group 1) 26.36 Std. deviation (Group 2) 103.83 Sample size 1 146 Sample size 2 146 Power (obtained) 0.798 For correction of a potential rounding error (calculated power 0.798) one case should be added to each group.
Although there will not be any study follow-ups the investigator still expects a drop-out rate of 30% for the following reason: As published previously, 67% of all corneal biopsies result in a positive culture. 13 In those cases, where the culture does not provide positive results, the patient will have to be excluded from the analysis.
Therefore, the investigator will include 147 + 147 + (147+147)*0.33 = 391.02 eyes -> 392 eyes Analysis of data is only possible, if the corneal biopsy is positive (a pathogen causing the keratitis is found). Therefore, the investigator expects that approximately 30% of the patients will not be included for analysis. In these cases, the OCT images will still be evaluated, but the tear film sample will be either disposed according to the protocol of tissue waste or if the investigating ophthalmologist expects a non-infectious type of keratitis (such as a neurotrophic ulcer) the cytokine quantification will be performed.
Measurement techniques CASIA 2 (Tomey, Japan) is a ss-OCT biometer that allows high resolution imaging of the anterior segment of the eye.
Tear sampling and cytokine analysis 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. Afterwards, the sample will be stored at -80° Celsius until all samples are collected. As mentioned in those samples, where the corneal biopsy was negative, will either be disposed, or (if the ophthalmology expects a non-infectious type of keratitis) still be analysed. Therefore, the conjunctival fluid from the syringes will be pooled and spun down in a centrifuge (400xg for 10 min at 4°C). The Supernatants will be analyzed using the pro-inflammatory multiplex assay kit from Meso Scale Discovery (Gaithersburg, MD, USA) for levels of the following cytokines and chemokines: IL-1alpha, IL-1beta, IL-6, IL-8, IL-10, IL-17A, TNF-alpha. Eighty samples will be analysed at the same time.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keratitis Group | – | Diagnostic Test: Tear Sample ProbePatients with clinically suspected bacterial or fungal keratitis |
Who may qualify
- Ages
- 18 to 119 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The participants will be recruited from the ambulances of Kepler University clinic, ophthalmology, Linz, Austria
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tear Sample ProbeSamples 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. | Diagnostic test | Keratitis Group |
Primary outcome
TNF Alpha in Tear Film
Time frame: The measurement is assessed at the point of study inclusion.
Comparison of TNF-alpha level differences in tear film between Gram+ and Gram- bacteria causing keratitis
2 secondary outcomes
Interleukins
Time frame: The measurement is assessed at the point of study inclusion.
Anterior segment Optical Coherence Tomography
Time frame: The measurement is assessed at the point of study inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 33414529Ting 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.
- Background: PubMed 33208864Konstantopoulos 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.
- Background: PubMed 33637814Konstantopoulos 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.
- Background: PubMed 10711694Chodosh J, Astley RA, Butler MG, Kennedy RC. Adenovirus keratitis: a role for interleukin-8. Invest Ophthalmol Vis Sci. 2000 Mar;41(3):783-9.
- Background: PubMed 32504999Peng 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.
- Background: PubMed 17189883Vasanthi 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.
- Background: PubMed 29673332Zhang 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.
- Background: PubMed 28491875Azher 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.
- Background: PubMed 32477330Wang 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.
- Background: PubMed 14507865Song 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.
- Background: PubMed 10225913Cole 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.
- Background: PubMed 12595449Cole 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.
- Individual participant dataSharing planned: Undecided. If IPD is going to be shared, is still in evaluation and will be decided throughout the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Bolz, MD principal investigator
JKU Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratitis Bacterial and Keratitis Fungal, run by Johannes Kepler University of Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nino D Hirnschall, MD,PhD (004373278061510, nino.hirnschall@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNF Alpha in Tear Film (time frame: The measurement is assessed at the point of study inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05620264, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.