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临床试验/NCT04416776
NCT04416776Unknown不适用

Validation of the Utility of Strabismus Intelligent Diagnostic System: A Clinical Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
323
试验地点
1
主要终点
The proportion of accurate, mistaken and miss detection of the diagnostic system.

研究概览

简要总结

Strabismus affects approximately 0.8%-6.8% of the world's population and appears by the age of 3 years in 65% of affected individuals. Manual measurement of deviation is often laborious and highly dependent on the experience of the specialist and the cooperation of the patients. Current strabismus evaluation technologies are heavily dependent on model eyes. Here, the investigators use deep learning to develop an artificial intelligence (AI) platform consisting of three deep learning (DL) systems to screen strabismus, evaluate deviation and propose a surgical plan based on corneal light-reflection photos. The investigator also conduct clinical trial to validate its versatility in clinical practice.

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

  • Patients in the outpatient clinic of strabismus department.

排除标准

  • Patients or their parents diagree to participate in the trial.
  • Patients with blepharoptosis.
  • Patients can't facing forward or lacking fixation.

研究组 & 干预措施

Eligible patients for AI test

Device: strabismus diagnostic system.

干预措施: Strabismus diagnostic system. (Drug)

结局指标

主要结局

The proportion of accurate, mistaken and miss detection of the diagnostic system.

时间窗: up to 3 years

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

研究点 (1)

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