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Development and Validation of a Deep Learning System for Multiple Ocular Fundus Diseases Using Retinal Images

Sun Yat-sen University logo

Sun Yat-sen University

Status

Unknown

Conditions

Ophthalmological Disorder

Treatments

Other: diagnostic

Study type

Observational

Funder types

Other

Identifiers

NCT04213430
CCPMOH2019- China8

Details and patient eligibility

About

Retinal images can reflect both fundus and systemic conditions (diabetes and cardiovascular disease) and firstly to be used for medical artificial intelligence (AI) algorithm training due to its advantages of clinical significance and easy to obtain. Here, the investigators developed a single network model that can mine the characteristics among multiple fundus diseases, which was trained by plenty of fundus images with one or several disease labels (if they have) in each of them. The model performance was compared with those of both native and international ophthalmologists. The model was further tested by datasets with different camera types and validated by three external datasets prospectively collected from the clinical sites where the model would be applied.

Enrollment

300,000 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • The quality of fundus images should clinical acceptable. More than 80% of the fundus image area including four main regions (optic disk, macular, upper and lower retinal vessel archs) are easy to read and discriminate.

Exclusion criteria

  • Images with light leakage (>30% of area), spots from lens flares or stains, and overexposure were excluded from further analysis.

Trial design

300,000 participants in 3 patient groups

Training dataset
Description:
Retinal images collected from hospitals and multiple screening sites all over China
Validation dataset
Description:
Retinal images separated from training dataset
Treatment:
Other: diagnostic
Testing dataset
Description:
Retinal images prospectively collected from the hospitals and ocular disease screening sites totally different from training dataset
Treatment:
Other: diagnostic

Trial contacts and locations

1

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Central trial contact

Haotian Lin, PhD

Data sourced from clinicaltrials.gov

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