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

Development and Validation of a Deep Learning System for Multiple Ocular Fundus Diseases Using Retinal Images: a Multi-center Prospective Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04213430
Enrollment
300000
Registered
2019-12-30
Start date
2014-01-31
Completion date
2020-05-31
Last updated
2019-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ophthalmological Disorder

Brief summary

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.

Interventions

OTHERdiagnostic

Training dataset was used to train the deep learning model, which was validated and tested by other two datasets.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Area under the receiver operating characteristic curve of the deep learning systembaselineThe investigators will calculate the area under the receiver operating characteristic curve of deep learning system and compare this index between deep learning system and human doctors.

Secondary

MeasureTime frameDescription
Sensitivity of the deep learning systembaselineThe investigators will calculate the sensitivity of deep learning system and compare this index between deep learning system and human doctors.
Specificity of the deep learning systembaselineThe investigators will calculate the specificity of deep learning system and compare this index between deep learning system and human doctors.

Countries

China

Contacts

Primary ContactHaotian Lin, PhD
gddlht@aliyun.com13802793086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026