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临床试验/NCT04592068
NCT04592068Unknown不适用

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

Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10,000
试验地点
1
主要终点
Sensitivity and specificity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • incomplete patient identification information

结局指标

主要结局

Sensitivity and specificity

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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