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

NCT ID: NCT04859634

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-12-25

Brief Summary

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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

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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

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Artificial Intelligence Diagnostic Imaging Abnormality of the Fundus Diagnostic Screening Programs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Beijin Tongren Hospital

The participant only needs to take an ultra-widefield fundus image as usual.

Taking an ultra-widefield fundus image

Intervention Type DEVICE

The participant only needs to take an ultra-widefield fundus image as usual.

Zhongshan Ophthalmic Center

The participant only needs to take an ultra-widefield fundus image as usual.

Taking an ultra-widefield fundus image

Intervention Type DEVICE

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.

Taking an ultra-widefield fundus image

Intervention Type DEVICE

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.

Taking an ultra-widefield fundus image

Intervention Type DEVICE

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.

Taking an ultra-widefield fundus image

Intervention Type DEVICE

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.

Taking an ultra-widefield fundus image

Intervention Type DEVICE

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.

Taking an ultra-widefield fundus image

Intervention Type DEVICE

The participant only needs to take an ultra-widefield fundus image as usual.

Interventions

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Taking an ultra-widefield fundus image

The participant only needs to take an ultra-widefield fundus image as usual.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shenzhen Eye Hospital

OTHER

Sponsor Role collaborator

Xudong Ophthalmic Hospital

UNKNOWN

Sponsor Role collaborator

IKang Physical Examination Center

UNKNOWN

Sponsor Role collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Yangxi General Hospital People's Hospital

UNKNOWN

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haotian Lin, MD, PhD

Role: CONTACT

8613802793086

Zhongwen Li, MD

Role: CONTACT

8618138726682

Facility Contacts

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Haotian Lin, M.D., Ph.D

Role: primary

8613802793086

Xiaohang Wu, M.D., Ph.D

Role: backup

8615913177657

Other Identifiers

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UWFAIDS2019-China-06

Identifier Type: -

Identifier Source: org_study_id

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