Artificial Intelligence Clinical Trial
Official title:
Real-time Artificial Intelligence System for Detecting Multiple Ocular Fundus Lesions by Ultra-widefield Fundus Imaging: A Prospective Multicenter Study
This prospective multicenter study will evaluate the efficacy of a real-time artificial intelligence system for detecting multiple ocular fundus lesions by ultra-widefield fundus imaging in real-world settings.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | December 25, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: All the participants who agree to take ultra-widefield fundus images. Exclusion Criteria: 1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths. 2. Patients who do not agree to sign informed consent. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University | Beijing Tongren Hospital, Guangdong Provincial People's Hospital, IKang Physical Examination Center, Shenzhen Eye Hospital, Xudong Ophthalmic Hospital, Yangxi General Hospital People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy | Performance of artificial intelligence system for detecting multiple ocular fundus lesions based on ultra-widefield fundus imaging. | 8 months | |
Secondary | Sensitivity | Performance of artificial intelligence system for detecting multiple ocular fundus lesions based on ultra-widefield fundus imaging. | 8 months | |
Secondary | Specificity | Performance of artificial intelligence system for detecting multiple ocular fundus lesions based on ultra-widefield fundus imaging. | 8 months | |
Secondary | Cohen's kappa coefficient | The comparison between the performacne of AI system and ophthalmologists of three degrees of expertise. | 8 months | |
Secondary | False-positive rate | Features of Misclassification | 8 months | |
Secondary | False-negative rate | Features of Misclassification | 8 months | |
Secondary | Data processing time of AI system | Data processing time of AI system. | 8 months |
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