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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05538793
Other study ID # NEH2022091015
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date October 20, 2023

Study information

Verified date October 2023
Source Ningbo Eye Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Detecting the cause of keratitis fast is the premise of providing targeted therapy for reducing vision loss and preventing severe complications. Due to overlapping inflammatory features, even expert cornea specialists have relatively poor performance in the identification of causative pathogen of infectious keraitis. In this project, the investigators aim to develop an automated and accurate deep learning system to discriminate among bacterial, fungal, viral, amebic and noninfectious keratitis based on slit-lamp images and evaluated this system using the datasets obtained from mutiple independent clinical centers across China.


Recruitment information / eligibility

Status Completed
Enrollment 10369
Est. completion date October 20, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Week to 100 Years
Eligibility Inclusion Criteria: Slit-lamp images with sufficient diagnostic certainty and showing keratitis at the active phase. Exclusion Criteria: - Poor-quality images - Images presenting mixed infections (i.e., cornea infected by two or more causative pathogens)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Ningbo Eye Hospital Ningbo Zhejiang
China Eye Hospital of Wenzhou Medical University Wenzhou

Sponsors (1)

Lead Sponsor Collaborator
Ningbo Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the receiver operating characteristic curve of the deep learning system 2020-2022
Secondary Accuracy of the deep learning system 2020-2022
Secondary Sensitivity of the deep learning system 2020-2022
Secondary Specificity of the deep learning system 2020-2022
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