Acanthamoeba KeratitisNCT06332703
Acanthamoeba and Artificial Intelligence
An observational study of Acanthamoeba Keratitis and Artificial Intelligence, run by IRCCS Ospedale San Raffaele.
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… Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Acanthamoeba Keratitis, Artificial Intelligence
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Performed corneal scraping and subsequent bacterioscopic exam, PCR and bacterial colture analysis between 2004 and 2023.
- Patients positivity to corneal infection.
Who cannot join
- Patients negativity to aforementioned exams.
About this study
Official title: 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.
Read more
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.
- Conditions
- Acanthamoeba Keratitis, Artificial Intelligence
- Keywords
- Acanthamoeba, Keratitis, Artificial intelligence, Corneal scraping, Confocal images, Acanthamoeba pattern, Machine learning
- Medical subject headings
- Acanthamoeba Keratitis, Keratitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images.
Measured: IVCM and laboratory samples will be acquired at day 0 (day of enrollment).
Secondary outcomes (1)
Correlation assessment between IVCM images and laboratory results.
Measured: IVCM and laboratory samples will be acquired at day 0 (day of enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study startMay 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acanthamoeba KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Ferrari, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332703
- Sponsor's protocol ID
- IACA
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25687209Dart 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.
PubMed 19660733Cabrera-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.
PubMed 35610943Zhang 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.
PubMed 37030037Rampat 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.
PubMed 34224467Lv 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.
PubMed 32617326
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acanthamoeba and Artificial Intelligence: Single-center Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06332703
- Acronym / sponsor ID
- IACA
- Conditions
- Acanthamoeba Keratitis, Artificial Intelligence
- Keywords
- Acanthamoeba, Keratitis, Artificial intelligence, Corneal scraping, Confocal images, Acanthamoeba pattern, Machine learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Performed corneal scraping and subsequent bacterioscopic exam, PCR and bacterial colture analysis between 2004 and 2023.
- Patients positivity to corneal infection.
Key exclusion criteria (1 listed)
- Patients negativity to aforementioned exams.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Correlation assessment between IVCM images and laboratory results.
Time frame: IVCM and laboratory samples will be acquired at day 0 (day of enrollment).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 25687209Lorenzo-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.
- Background: PubMed 19660733Dart 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.
- Background: PubMed 35610943Cabrera-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.
- Background: PubMed 37030037Zhang 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.
- Background: PubMed 34224467Rampat 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.
- Background: PubMed 32617326Lv 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acanthamoeba Keratitis and Artificial Intelligence, run by IRCCS Ospedale San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06332703, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.