MedPath

Acanthamoeba and Artificial Intelligence

Not yet recruiting
Conditions
Acanthamoeba Keratitis
Artificial Intelligence
Registration Number
NCT06332703
Lead Sponsor
IRCCS Ospedale San Raffaele
Brief Summary

Acanthamoeba keratitis, caused by the pathogen Acanthamoeba spp, is recognized worldwide as a severe ocular infection that can pose potential risks to vision.

This observational retrospective and single-center study, of exploratory nature, aims to determine the possibility of identifying patterns that may be useful for future rapid diagnosis of Acanthamoeba keratitis from confocal images, leveraging the normality of corneal examination and the high specificity and sensitivity of computational models.

The data will be based on patients who have been confirmed positive through laboratory tests with proven effectiveness in detecting the infection.

The laboratory tests considered for the division of patients into their respective groups are bacterial examination, PCR examination, and culture examination.

Patients were divided into two groups, the first comprising patients positive for Acanthamoeba infection, while the second comprised patients negative for Acanthamoeba but positive for other pathogens. The study will last for 18 months.

The cohort under study includes 151 patients from the IRCCS San Raffaele Hospital who underwent the aforementioned examinations, of which 76 cases will be included in the group of patients positive for Acanthamoeba and 75 in the group of controls positive for other pathogens.

The confocal images of this cohort will be fed into artificial intelligence software. To evaluate the model, the test set will be used, and the AI model's ability will be assessed using the most commonly used metrics in the field of computer vision such as accuracy, specificity, sensitivity, and f1-score; culminating in a comprehensive evaluation of the model.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
151
Inclusion Criteria
  • Performed corneal scraping and subsequent bacterioscopic exam, PCR and bacterial colture analysis between 2004 and 2023.
  • Patients positivity to corneal infection.
Exclusion Criteria
  • Patients negativity to aforementioned exams.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images.IVCM and laboratory samples will be acquired at day 0 (day of enrollment).
Secondary Outcome Measures
NameTimeMethod
Correlation assessment between IVCM images and laboratory results.IVCM and laboratory samples will be acquired at day 0 (day of enrollment).
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