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临床试验/NCT05835115
NCT05835115已完成不适用

Development and Validation of a Deep Learning-based Myopia and Myopic Maculopathy Detection and Prediction System

Shanghai Eye Disease Prevention and Treatment Center1 个研究点 分布在 1 个国家目标入组 30,526 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30,526
试验地点
1
主要终点
predicted future annual spherical equivalent

研究概览

简要总结

Myopia has become a global public health issue. Myopia affects the psychological health of children and adolescents and poses a financial burden. Therefore, early detection and prediction of children at a high risk of myopia development and progression are critical for precise and effective interventions. In this study, we developed a deep learning system DeepMyopia, based on fundus images with the following objectives: 1) to predict myopia onset and progression; 2) To detect myopic macular degeneration for AI-assisted diagnosis; 3) To predict the development of myopic macular degeneration; 4) evaluate its cost-effectiveness.

详细描述

Myopia has become a global public health issue. Myopia affects the psychological health of children and adolescents and poses a financial burden. Furthermore, as myopia progresses it increases the risk of ocular complications such as myopic macular degeneration, leading to irreversible visual impairment or even blindness. According to the World Health Organization , more than 1 billion people worldwide are living with vision impairment caused by myopia, hyperopia, and other problems due to late detection. Therefore, early detection and prediction of children at a high risk of myopia development and progression are critical for precise and effective interventions.

In this study, we developed a deep learning system DeepMyopia, based on fundus images with the following objectives: 1) to predict myopia onset and progression; 2) To detect myopic macular degeneration for AI-assisted diagnosis; 3) To predict the development of myopic macular degeneration; 4) evaluate its cost-effectiveness.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with fundus images in the Shanghai Child and Adolescent Large-scale Eye Study (SCALE) ;
  • Subjects with fundus images in the Shanghai Time Outside to Reduce Myopia [STORM] trial;
  • Subjects with fundus images in the High Myopia Registration Study [SCALE-HM]
  • Subjects with fundus images in the Shanghai Myopia Screening (SMS) Study;
  • Subjects with fundus images in the Beijing Children Eye Study
  • Subjects with fundus images in the First Affiliated Hospital of Kunming Medical University;
  • Subjects with fundus images at the Ophthalmology Department of the First Affiliated Hospital of Xinjiang Medical University;
  • Subjects with fundus images at the Ophthalmology Department of the Affiliated Hospital of Inner Mongolia Medical University;
  • Subjects with fundus images at Zhongshan Eye Centre, Sun Yat-sen University;
  • Subjects with fundus images in the Hong Kong Children Eye Study;

排除标准

  • Participants with poor-quality fundus images

结局指标

主要结局

predicted future annual spherical equivalent

时间窗: immediately after inputting the data

output of predicting future spherical equivalent task

predicted spherical equivalent

时间窗: immediately after inputting the data

output of assessing spherical equivalent task

myopia staging detection possibility score

时间窗: immediately after inputting the data

output of myopia staging task

myopic maculopathy detection possibility score

时间窗: immediately after inputting the data

output of myopic maculopathy detection task

risk score of myopia and myopic maculopathy progression

时间窗: immediately after inputting the data

output of the progression of myopia and myopic maculopathy predicion task

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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