An observational study in Infectious Keratitis, sponsored by Sorlandet Hospital HF. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by Sorlandet Hospital HF · Observational
Infectious keratitis is a significant cause of partial vision loss and blindness and places a large burden on eye care professionals. One of the main challenges for the ophthalmologist when presented with a case of suspected microbial keratitis is the determination of the subtype of keratitis. It must be determined whether the origin of the infection is bacterial, viral, fungal, or parasitic, in order to prescribe a correct, effective treatment aimed at the causative pathogen. In daily practice this can be challenging, and general treatments with antibiotics are prescribed. Some cases then experiences deterioration, resulting in more patients visits and further rounds of invasive treatments and progressive vision deterioration.
This project is designed to break this cycle of nonspecific diagnosis, suboptimal treatment, and progressive worsening of vision with increased interventions. New, advanced diagnostics will be brought into the clinic to provide additional information which, if our hypothesis is correct, will result in more rapid and accurate diagnosis of the keratitis subtype. This will translate into earlier administration of a more targeted treatment, avoiding the repeated round of non-targeted treatment and progressive worsening of the patient's vision. This can directly reduce to number of clinic visits and specialist time required for treatment and follow-up of keratitis, knowledge of how the eye responds to various microbes by initiating a specific cascade of molecular inflammatory signals and changes in protein expression in the tear film.
Using in vivo confocal microscopy (IVCM) we will document the cellular status of the cornea and identify microbes infecting the cornea in real-time. Secondly, tear samples will be obtained from patients with keratitis to evaluate and quantify the molecular cytokine signatures associated with specific microbial species, confirmed by microbiological culture. We will for the first time develop cytokine profiles for the various types of infection, identifying diagnostic cytokines which in the longer term can lead to development of rapid point-of-care biomarker diagnostics.
The project aims are translated into the following hypotheses:
H1: In vivo confocal microscopy imaging features detect microbial keratitis consistent with clinical assessment and outcome at a greater frequency than microbiological culture results.
H2: Cytokine profiles (or a subset of molecules) in the eye are specific for viral, bacterial, fungal, or amoebic keratitis; and H3: A combination of in vivo confocal microscopy and molecular profiling of the tear film can yield a specific keratitis diagnosis closely matching the clinical progression and outcome of keratitis.
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's planned enrollment of 125 is above the median of 105 across 31 observational studies indexed under Keratitis.
Browse Keratitis studies →Sorlandet Hospital HF is the lead sponsor of 74 studies on the registry; 12 are open to participants now.
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Patients with clinically suspected infectious keratitis, over 18 years of age, presenting to the ophthalmology department at Arendal hospital.
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Diagnostic Test: In vivo confocal microscopy · Diagnostic Test: Tear film sampling
Diagnostic Test: In vivo confocal microscopy · Diagnostic Test: Tear film sampling
The patients cornea will be examined non-invasively by IVCM
Also known as: IVCM
Patients tear film will be collected and stored at -80 degrees for analysis
IVCM findings and cytokine profile in infectious keratitis is specific for the different microbial subtypes.
A combination of in vivo confocal microscopy and molecular profiling of the tear film can yield a specific keratitis diagnosis closely matching the clinical progression and outcome of keratitis.
Time frame: 18 months
Plan to share: Undecided — Currently there is not a plan to share individual data outside the project group due to confidentiality. If the investigators later would want to do this, new applications to the correct boards are needed.
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Mar 2025, 18 months after the start.
Of 16 observational studies under Keratitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 34. This study's planned 18 months is below that.
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Sorlandet Hospital HF