An observational study in Acanthamoeba Keratitis and Artificial Intelligence, sponsored by IRCCS Ospedale San Raffaele. Not yet recruiting. Open to participants aged 1 Year to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by IRCCS Ospedale San Raffaele · Observational
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.
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's planned enrollment of 151 is above the median of 105 across 31 observational studies indexed under Keratitis.
Browse Keratitis studies →IRCCS Ospedale San Raffaele is the lead sponsor of 36 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Based on the results of the exams previously described in the eligibility criteria, two groups of patients will be created:
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.
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.
Exclusion Criteria:
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).
Correlation assessment between IVCM images and laboratory results.
Time frame: IVCM and laboratory samples will be acquired at day 0 (day of enrollment).
No study locations are listed for this record.
Start is estimated for May 2024; primary completion for Oct 2024, 5 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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IRCCS Ospedale San Raffaele