NCT04592068

AI Classifies Multi-Retinal Diseases

Deep Learning-Based Automated Classification of Multi-Retinal Disease From Fundus Photography

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of this study is to establish deep learning (DL) algorithm to automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities. The effectiveness and accuracy of the established algorithm will be evaluated in community derived dataset.

Detailed description

Retinal diseases seriously threaten vision and quality of life, but they often develop insidiously. To date, deep learning (DL) algorithms have shown high prospects in biomedical science, particularly in the diagnosis of ocular diseases, such as diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, glaucoma, and papilledema. However, there is still a lack of a single algorithm that can classify multi-diseases from fundus photography. This cross-sectional study will establish a DL algorithm to automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities. We will use the receiver operating characteristic (ROC) curve to examine the ability of recognition and classification of diseases. Taken the results of the expert panel as the gold standard, we will use the evaluation indexes, such as sensitivity, specificity, accuracy, positive predictive value, negative predictive value, etc, to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

Conditions

• Deep Learning
• Retinal Diseases

Interventions

Type	Name	Description
DEVICE	Retinal multi-diseases diagnosed by DL algorithm	DL algorithm automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities.
OTHER	Retinal multi-diseases diagnosed by expert panel	Expert panel classifies multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities.

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-11-01
• Completion: 2021-12-01
• First posted: 2020-10-19
• Last updated: 2020-12-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study