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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06332703
Other study ID # IACA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date April 2025

Study information

Verified date March 2024
Source IRCCS Ospedale San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 151
Est. completion date April 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 99 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Ospedale San Raffaele

References & Publications (6)

Cabrera-Aguas M, Khoo P, Watson SL. Infectious keratitis: A review. Clin Exp Ophthalmol. 2022 Jul;50(5):543-562. doi: 10.1111/ceo.14113. Epub 2022 Jun 3. — View Citation

Dart JK, Saw VP, Kilvington S. Acanthamoeba keratitis: diagnosis and treatment update 2009. Am J Ophthalmol. 2009 Oct;148(4):487-499.e2. doi: 10.1016/j.ajo.2009.06.009. Epub 2009 Aug 5. — View Citation

Lorenzo-Morales J, Khan NA, Walochnik J. An update on Acanthamoeba keratitis: diagnosis, pathogenesis and treatment. Parasite. 2015;22:10. doi: 10.1051/parasite/2015010. Epub 2015 Feb 18. — View Citation

Lv J, Zhang K, Chen Q, Chen Q, Huang W, Cui L, Li M, Li J, Chen L, Shen C, Yang Z, Bei Y, Li L, Wu X, Zeng S, Xu F, Lin H. Deep learning-based automated diagnosis of fungal keratitis with in vivo confocal microscopy images. Ann Transl Med. 2020 Jun;8(11):706. doi: 10.21037/atm.2020.03.134. — View Citation

Rampat R, Deshmukh R, Chen X, Ting DSW, Said DG, Dua HS, Ting DSJ. Artificial Intelligence in Cornea, Refractive Surgery, and Cataract: Basic Principles, Clinical Applications, and Future Directions. Asia Pac J Ophthalmol (Phila). 2021 Jul 1;10(3):268-281. doi: 10.1097/APO.0000000000000394. — View Citation

Zhang Y, Xu X, Wei Z, Cao K, Zhang Z, Liang Q. The global epidemiology and clinical diagnosis of Acanthamoeba keratitis. J Infect Public Health. 2023 Jun;16(6):841-852. doi: 10.1016/j.jiph.2023.03.020. Epub 2023 Mar 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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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