Real-time Artificial Intelligence System for Detecting Multiple Ocular Fundus Lesions by Ultra-widefield Fundus Imaging
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 15, 2021
CompletedFirst Posted
Study publicly available on registry
April 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 25, 2022
CompletedApril 26, 2021
April 1, 2021
1.3 years
April 15, 2021
April 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy
Performance of artificial intelligence system for detecting multiple ocular fundus lesions based on ultra-widefield fundus imaging.
8 months
Secondary Outcomes (6)
Sensitivity
8 months
Specificity
8 months
Cohen's kappa coefficient
8 months
False-positive rate
8 months
False-negative rate
8 months
- +1 more secondary outcomes
Study Arms (7)
Zhongshan Ophthalmic Center
The participant only needs to take an ultra-widefield fundus image as usual.
Shenzhen Ophthalmic Center
The participant only needs to take an ultra-widefield fundus image as usual.
Beijin Tongren Hospital
The participant only needs to take an ultra-widefield fundus image as usual.
Xudong Ophthalmic Center
The participant only needs to take an ultra-widefield fundus image as usual.
IKang Physical Examination Center
The participant only needs to take an ultra-widefield fundus image as usual.
Yangxi General Hospital People's Hospital
The participant only needs to take an ultra-widefield fundus image as usual.
Guangdong Provincial People's Hospital
The participant only needs to take an ultra-widefield fundus image as usual.
Interventions
The participant only needs to take an ultra-widefield fundus image as usual.
Eligibility Criteria
All the participants who agree to take ultra-widefield fundus images.
You may qualify if:
- All the participants who agree to take ultra-widefield fundus images.
You may not qualify if:
- Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
- Patients who do not agree to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Shenzhen Eye Hospitalcollaborator
- Xudong Ophthalmic Hospitalcollaborator
- IKang Physical Examination Centercollaborator
- Beijing Tongren Hospitalcollaborator
- Guangdong Provincial People's Hospitalcollaborator
- Yangxi General Hospital People's Hospitalcollaborator
Study Sites (1)
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 15, 2021
First Posted
April 26, 2021
Study Start
November 1, 2020
Primary Completion
February 1, 2022
Study Completion
December 25, 2022
Last Updated
April 26, 2021
Record last verified: 2021-04