跳至主要内容
临床试验/NCT03476291
NCT03476291Unknown不适用

Research of Automated Maculopathy Screening by Optical Coherent Tomography Image-based Deep Learning Techniques

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2017年6月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20,000
试验地点
1
主要终点
receiver operating characteristic(ROC) curve of the algorithm

研究概览

简要总结

The investigators expect to develop an algorithm that can interpret OCT images and automated determine whether the macula is normal or not by using OCT image-based deep learning techniques. And investigators wish to develop software applications that will help better screen and diagnose macular diseases in resource-limited areas.

详细描述

The investigators will apply deep learning convolutional neural network by using ImageNet for an automated detection of multiple retinal diseases with OCT horizontal B-scans with a high-quality labeled database. Datasets, including training dataset, testing dataset and validation datasets, will be built by ophthalmologists of the First affiliated hospital of Nanjing Medical University according to the standardized annotation guidelines.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •All patients attending the Ophthalmology Department of the First Affiliated Hospital of Nanjing Medical University within 5 years and who received known, clear diagnoses with digital retinal imaging (including OCT, fundus digital photographs and fundus fluorescein angiography, at least with OCT images) as part of their routine clinical care, will be eligible for inclusion in this study.

排除标准

  • •Hardcopy examinations (i.e., photos of paper reports of OCT imaging performed at other hospitals) will be ineligible.
  • •Data from patients who have previously manually requested that their data should not be shared, even for research purposes in anonymised form, and have informed the Ophthalmology Department of the First Affiliated Hospital of Nanjing Medical University of this desire (even in previously conducted studies or other on-going studies in this hospital), will be excluded, and their data will not be upload to the cloud platform before research begins.
  • •Data from eyes tamponed with silicone oil or gas (i.e., C3F8) will be ineligible.
  • •Data with poor image quality, such as incomplete images, inverted images, blurred or cracked images and images with a very weak signal (i.e., vitreous haemorrhage), will be ineligible.

结局指标

主要结局

receiver operating characteristic(ROC) curve of the algorithm

时间窗: approximately 1 year

It is also called sensitivity curve. The ROC curve shows how sensitive the algorithm model is to automatically detect the desired output.

Area under the ROC curve(AUC)

时间窗: approximately 1 year

It shows the operating value of the algorithm model, which can represent the effect of the model.

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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