NCT04859634

Real-time Artificial Intelligence System for Detecting Multiple Ocular Fundus Lesions by Ultra-widefield Fundus Imaging

Real-time Artificial Intelligence System for Detecting Multiple Ocular Fundus Lesions by Ultra-widefield Fundus Imaging: A Prospective Multicenter Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The ocular fundus can show signs of both ocular diseases (e.g., lattice degeneration, retinal detachment and glaucoma) and systemic diseases (e.g., hypertension, diabetes and leukemia). The routine fundus examination is conducive for early detection of these diseases. However, manual conducting fundus examination needs an experienced retina ophthalmologist, and is time-consuming and labor-intensive, which is difficult for its routine implementation on large scale. This study will develop an artificial intelligence system integrating with ultra-widefield fundus imaging to automatically screen for multiple ocular fundus lesions in real time and evaluate its performance in different real-world settings. The efficacy of the system will compare to the final diagnoses of each participant made by experienced ophthalmologists.

Conditions

• Artificial Intelligence
• Diagnostic Imaging
• Abnormality of the Fundus
• Diagnostic Screening Programs

Interventions

Type	Name	Description
DEVICE	Taking an ultra-widefield fundus image	The participant only needs to take an ultra-widefield fundus image as usual.

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-02-01
• Completion: 2022-12-25
• First posted: 2021-04-26
• Last updated: 2021-04-26

Locations

1 site across 1 country: China