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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06364878
Other study ID # 813533
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 23, 2023
Est. completion date April 8, 2028

Study information

Verified date April 2023
Source Sorlandet Hospital HF
Contact Ingvild M Bakken
Phone 37014856
Email ingvild.mygland.bakken@sshf.no
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 125
Est. completion date April 8, 2028
Est. primary completion date March 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinically suspected infectious keratitis in patients over 18 years of age - Patients with acceptable travel distance to the hospital - Patients accepting to be part of the study Exclusion Criteria: - Previously diagnosed infectious keratitis during the last 6 months - Over 50 percent thinning of the cornea - Previous use of antibiotics (other than Chloramphenicol)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
In vivo confocal microscopy
The patients cornea will be examined non-invasively by IVCM
Tear film sampling
Patients tear film will be collected and stored at -80 degrees for analysis

Locations

Country Name City State
Norway Sorlandet hospital Arendal

Sponsors (1)

Lead Sponsor Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 18 months
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