跳至主要内容
临床试验/NCT03623971
NCT03623971已完成不适用

Validation of the Utility of a Universal Cataract Intelligence Platform

Sun Yat-sen University0 个研究点目标入组 500 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
主要终点
Diagnostic accuracy of the cataract AI agent

研究概览

简要总结

This study established and validated a universal artificial intelligence (AI) platform for collaborative management of cataracts involving multi-level clinical scenarios and explored an AI-based medical referral pattern to improve collaborative efficiency and resource coverage.The datasets were labeled using a three-step strategy: (1) categorize slit lamp photographs into four separate capture modes; (2) diagnose each photograph as a normal lens, cataract or a postoperative eye; and (3) based on etiology and severity, further classify each diagnosed photograph for a management strategy of referral or follow-up. A deep residual convolutional neural network (CS-ResCNN) was used for the image classification task. Moreover, we integrated the cataract AI agent with a real-world multi-level referral pattern involving self-monitoring at home, primary healthcare, and specialized hospital services.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients who underwent ophthalmic examination of the eye and recorded their ocular information in the primary healthcare center.

排除标准

  • •The patients who cannot cooperate with the examinations.

研究组 & 干预措施

Artificial Intelligence

Experimental

A universal diagnostic system. An artificial intelligence to make comprehensive evaluation and treatment decision of cataract.

干预措施: Cataract AI agent (Device)

结局指标

主要结局

Diagnostic accuracy of the cataract AI agent

时间窗: 6 months

AUC: area under the receiver operating curve; accuracy (ACC) = (TP + TN) / (TP + TN + FP + FN); sensitivity (SEN) = TP / (TP + FN); specificity (SPE) = TN / (TN + FP); TP = true positive; TN = true negative; FP = false positive; FN = false negative.

次要结局

未报告次要终点

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haotian Lin

Clinical Professor

Sun Yat-sen University

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