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Clinical Trials/NCT04592068
NCT04592068
Unknown
Not Applicable

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

Beijing Tongren Hospital1 site in 1 country10,000 target enrollmentNovember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deep Learning
Sponsor
Beijing Tongren Hospital
Enrollment
10000
Locations
1
Primary Endpoint
Sensitivity and specificity
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
December 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Tongren Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • fundus photography around 45° field which covers optic disc and macula
  • complete patient identification information;

Exclusion Criteria

  • incomplete patient identification information

Outcomes

Primary Outcomes

Sensitivity and specificity

Time Frame: 1 week

Taken the results of the expert panel as the gold standard, we will use sensitivity and specificity to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

Accuracy

Time Frame: 1 week

Taken the results of the expert panel as the gold standard, we will use accuracy to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

Positive and negative predictive value

Time Frame: 1 week

Taken the results of the expert panel as the gold standard, we will use positive and negative predictive value to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

Area under curve

Time Frame: 1 week

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 area under curve to compare the diagnostic capacity between the AI recognition system and human ophthalmologist.

Study Sites (1)

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