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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Unknown

Conditions

Diagnostic Screening Programs
Artificial Intelligence
Diagnostic Imaging
Abnormality of the Fundus

Treatments

Device: Taking an ultra-widefield fundus image

Study type

Observational

Funder types

Other

Identifiers

NCT04859634
UWFAIDS2019-China-06

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

2,000 participants in 7 patient groups

Zhongshan Ophthalmic Center
Description:
The participant only needs to take an ultra-widefield fundus image as usual.
Treatment:
Device: Taking an ultra-widefield fundus image
Shenzhen Ophthalmic Center
Description:
The participant only needs to take an ultra-widefield fundus image as usual.
Treatment:
Device: Taking an ultra-widefield fundus image
Beijin Tongren Hospital
Description:
The participant only needs to take an ultra-widefield fundus image as usual.
Treatment:
Device: Taking an ultra-widefield fundus image
Xudong Ophthalmic Center
Description:
The participant only needs to take an ultra-widefield fundus image as usual.
Treatment:
Device: Taking an ultra-widefield fundus image
IKang Physical Examination Center
Description:
The participant only needs to take an ultra-widefield fundus image as usual.
Treatment:
Device: Taking an ultra-widefield fundus image
Yangxi General Hospital People's Hospital
Description:
The participant only needs to take an ultra-widefield fundus image as usual.
Treatment:
Device: Taking an ultra-widefield fundus image
Guangdong Provincial People's Hospital
Description:
The participant only needs to take an ultra-widefield fundus image as usual.
Treatment:
Device: Taking an ultra-widefield fundus image

Trial contacts and locations

1

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Central trial contact

Haotian Lin, MD, PhD; Zhongwen Li, MD

Data sourced from clinicaltrials.gov

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