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【ChiCTR2500104716】A novel deep learning-based three-dimensional retinal vascular analysis for progression risk stratification in glaucoma patients

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基本信息

登记号

ChiCTR2500104716

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-06-23

临床申请受理号

靶点

适应症

Glaucoma

试验通俗题目

A novel deep learning-based three-dimensional retinal vascular analysis for progression risk stratification in glaucoma patients

试验专业题目

A novel deep learning-based three-dimensional retinal vascular analysis for progression risk stratification in glaucoma patients

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

Aim 1 • To develop a novel deep learning-based 3D model for retinal vasculature analysis in glaucoma patients. Aim 2 • To integrate the novel biomarkers of our proposed 3D DL retinal vasculature system with clinical biomarkers for the establishment of a risk stratification model of glaucoma progression.

试验分类

试验类型

诊断试验诊断准确性

试验分期

其它

随机化

盲法

试验项目经费来源

Health and Medical Research Fund

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-07-01

试验终止时间

2027-04-30

是否属于一致性

入选标准

1. Older than 18 years 2. Best corrected visual acuity (BCVA) no less than 20/40. 3. No severe systemic disorders (i.e., those without clinical retinal involvement). 4. Glaucoma is defined when at least one eye had the presence of the structural and functional evidence of glaucoma, including glaucomatous optic disc cupping, RNFL damage, or neuroretinal rim loss, and minimal criteria for glaucomatous VF defect as per published standard (38): glaucoma hemifield test result outside normal limits, pattern standard deviation (PSD) with P < 0.05 or a cluster of 3 or more points in the pattern deviation plot in a single hemifield with P < 0.05, one of which must have P < 0.01. Any one of the preceding criteria, if repeatable, was considered sufficient evidence for the glaucomatous visual field (VF) defect.；

排除标准

1. Other ocular diseases that may cause retinal vascular change, such as diabetic retinopathy, hypertension retinopathy; or AMD. 2. Extremely myopia (i.e., axial length > 27.0 mm). 3. OCTA images with insufficient image quality.；

研究者信息

研究负责人姓名

试验机构

The Chinese University of Hong Kong

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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