Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT04859634
Status:
UNKNOWN
Last Update Posted:
2021-04-26
First Post:
2021-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Artificial Intelligence System for Detecting Multiple Ocular Fundus Lesions by Ultra-widefield Fundus Imaging
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Real-time Artificial Intelligence System for Detecting Multiple Ocular Fundus Lesions by Ultra-widefield Fundus Imaging: A Prospective Multicenter Study
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: