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NCT Number: NCT06364878

Non-invasive Diagnostics of Microbial Keratitis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sorlandet hospital

Arendal, Norway

Location status: Recruiting

Location contact

Neil Lagali

CONTACT

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

In vivo confocal microscopy

Diagnostic Test

The patients cornea will be examined non-invasively by IVCM

Other names: IVCM

Tear film sampling

Diagnostic Test

Patients tear film will be collected and stored at -80 degrees for analysis

Primary outcomes

  1. IVCM findings and cytokine profile in infectious keratitis is specific for the different microbial subtypes.

    Time frame: 18 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ingvild M Bakken

CONTACT

[email protected]

37014856

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

New Non-invasive Cellular and Molecular Diagnostics of Microbial Keratitis

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Apr 15, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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