Acanthamoeba and Artificial Intelligence

May 8, 2024 updated by: Giulio Ferrari, IRCCS Ospedale San Raffaele

Acanthamoeba and Artificial Intelligence: Single-center Retrospective Observational Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Based on the results of the exams previously described in the eligibility criteria, two groups of patients will be created:

  • Patients positive for Acanthamoeba infection.
  • Patients negative for Acanthamoeba infection but positive for infection of another pathogen.

Confocal images of about 75 subjects from the first group and 76 from the second group, used as controls, will be entered into the artificial intelligence software.

The sample size, of this retrospective study, is based on the availability of data available in our database regarding the inclusion criteria of the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images.
Time Frame: IVCM and laboratory samples will be acquired at day 0 (day of enrollment).
IVCM and laboratory samples will be acquired at day 0 (day of enrollment).

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation assessment between IVCM images and laboratory results.
Time Frame: IVCM and laboratory samples will be acquired at day 0 (day of enrollment).
IVCM and laboratory samples will be acquired at day 0 (day of enrollment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IACA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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