跳至主要内容
临床试验/NCT07471971
NCT07471971已完成不适用

Assessment of Hypertensive Retinopathy Using Keith Wagener Barker's Classification, Based on Neural Network "RetinAIcheck"

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 755 人开始时间: 2021年3月11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
入组人数
755
试验地点
1
主要终点
Accuracy

研究概览

简要总结

The current study is aimed at estimating the diagnostic effectiveness of a developed neural network "RetinAIcheck" in grading the severity of hypertensive retinopathy in patients of the Russian population.

The training data set was obtained from an open source and relabeled by seven independent retina specialists, the sample size was 30,000 fundus photographs. The test sample included 755 patients (1374 eyes). Among the 1.374 eyes, 94 were without HR (class 0), 330 had class 1, 660 had class 2, 280 had class 3, and 10 had class 4 HR.The reference standard was the result of independent grading of HR stage by two ophthalmologists, controversial clinical cases were evaluated with the involvement of a third ophthalmologist.

研究设计

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

入排标准

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

入选标准

  • - Patients with and without a diagnosis of arterial hypertension, based on medical records

排除标准

  • anophthalmia,
  • optic nerve atrophy,
  • eyeball injuries,
  • age-related macular degeneration,
  • central serous chorioretinopathy,
  • central serous chorioretinitis,
  • clouding of the optical media of the eye, which affects the quality of the image.

研究组 & 干预措施

Class 0 without signs of hypertensive retinopathy

干预措施: Convolutional neural network "RetinAIcheck" (Diagnostic Test)

Class 1 hypertensive retinopathy

干预措施: Convolutional neural network "RetinAIcheck" (Diagnostic Test)

Class 2 hypertensive retinopathy

干预措施: Convolutional neural network "RetinAIcheck" (Diagnostic Test)

Class 3 hypertensive retinopathy

干预措施: Convolutional neural network "RetinAIcheck" (Diagnostic Test)

Class 3+4 hypertensive retinopathy

干预措施: Convolutional neural network "RetinAIcheck" (Diagnostic Test)

结局指标

主要结局

Accuracy

时间窗: The ability to correctly identify the presence or absence of condition

The ability of a test to correctly identify the proportion of true positive cases

次要结局

  • Positive predictive value(February 2026)
  • Negative predictive value(February 2026)
  • AUROC, area under the ROC curve (one-versus-rest)(February 2026)
  • Quadratically weighted kappa(February 2026)
  • Sensitivity(February 2026)
  • Specificity(February 2026)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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