Acanthamoeba and Artificial Intelligence: Single-center Retrospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 151
- 主要终点
- Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 99 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Performed corneal scraping and subsequent bacterioscopic exam, PCR and bacterial colture analysis between 2004 and
- •Patients positivity to corneal infection.
排除标准
- •Patients negativity to aforementioned exams.
结局指标
主要结局
Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images.
时间窗: IVCM and laboratory samples will be acquired at day 0 (day of enrollment).
次要结局
- Correlation assessment between IVCM images and laboratory results.(IVCM and laboratory samples will be acquired at day 0 (day of enrollment).)
研究者
Giulio Ferrari
Professor of Ophthalmology-San Raffaele Vita Salute University, Cornea and Ocular Surface Unit; Head-Eye Repair Lab San Raffaele Scientific Institute
IRCCS Ospedale San Raffaele
