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Acanthamoeba and Artificial Intelligence

Acanthamoeba and Artificial Intelligence: Single-center Retrospective Observational Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06332703
Enrollment
151
Registered
2024-03-27
Start date
2024-05-31
Completion date
2025-04-30
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acanthamoeba Keratitis, Artificial Intelligence

Keywords

Acanthamoeba, Keratitis, Artificial intelligence, Corneal scraping, Confocal images, Acanthamoeba pattern, Machine learning

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.

Interventions

None listed

Sponsors

IRCCS Ospedale San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Correlation assessment between IVCM images and laboratory results.IVCM and laboratory samples will be acquired at day 0 (day of enrollment).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026