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RecruitingNCT06364878Updated Apr 15, 2024

Non-invasive Diagnostics of Microbial Keratitis

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

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
125
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Infectious Keratitis

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03

In context

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 →

Lead sponsor

Sorlandet Hospital HF is the lead sponsor of 74 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients with clinically suspected infectious keratitis, over 18 years of age, presenting to the ophthalmology department at Arendal hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
125 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patents with suspected infectious keratitis

    Diagnostic Test: In vivo confocal microscopy · Diagnostic Test: Tear film sampling

  • Healthy controls

    Diagnostic Test: In vivo confocal microscopy · Diagnostic Test: Tear film sampling

Interventions

  • Diagnostic testIn vivo confocal microscopy

    The patients cornea will be examined non-invasively by IVCM

    Also known as: IVCM

  • Diagnostic testTear film sampling

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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2024
First posted
Apr 15, 2024
StartActual
Aug 23, 2023
Primary completionEst.
Mar 1, 2025
CompletionEst.
Apr 8, 2028
Last update
Apr 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06364878
Lead sponsor
Sorlandet Hospital HF
Responsible party
Sponsor
First posted
Apr 15, 2024
Start date
Aug 23, 2023
Primary completion
Mar 1, 2025 (estimated)
Completion
Apr 8, 2028 (estimated)
Last update
Apr 15, 2024

Study contacts

Ingvild M Bakken
Contact
ingvild.mygland.bakken@sshf.no
37014856
Neil Lagali
principal investigator · Sorlandet Hospital HF

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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