A Study to Evaluate the Clinical Performance of VeriSee GLC for Screening of Glaucoma Suspect Using Color Fundus Images
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 773
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the VeriSee GLC for screening glaucoma suspects
研究概览
简要总结
The goal of this observational study is to evaluate the clinical performance of VeriSee GLC for identifying glaucoma suspects using color fundus images in adult participants. The main questions it aims to answer are:
- What are the sensitivity and specificity of VeriSee GLC for detecting glaucoma suspects based on fundus images?
- How does the performance of VeriSee GLC compare with the reference standard defined by the majority consensus of three independent evaluators?
Researchers will compare the screening results generated by VeriSee GLC with the reference standard to assess its diagnostic performance.
This retrospective study will use previously collected fundus images. VeriSee GLC performs automated image analysis to identify glaucomatous signs, including retinal nerve fiber layer (RNFL) defects, vertical cup-to-disc ratio (VCDR) enlargement, and rim-to-disc ratio (RDR) changes. The output is intended to assist healthcare professionals in identifying glaucoma suspects for referral, rather than providing a definitive diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The adult color fundus image (aged 20 and above)
- •The requirements of color fundus image
- •The resolution of image is 1024 × 1024 pixels or higher;
- •The angle view of image is 45-or 50-degree.
- •Images captured from eyes with myopia not exceeding -10 diopters.
- •The color fundus image includes the optic disc and RNFL areas, and one of these areas is evaluable, as judged by the healthcare professionals.
排除标准
- •The color fundus images previously used by VeriSee GLC during the development process and pre-clinical test.
- •A color fundus image of patients with cataracts, acute angle closure glaucoma or those who have undergone retinal laser surgery.
- •The optic disc and RNFL areas in the color fundus images is invisible to determine the disease condition as judged by the healthcare professionals.
结局指标
主要结局
Sensitivity and specificity of the VeriSee GLC for screening glaucoma suspects
时间窗: 1 Day
The primary outcome is the sensitivity and specificity of the VeriSee GLC in identifying glaucoma suspects based on color fundus images, compared against the reference standard defined by the majority consensus of three independent evaluators.
次要结局
- Positive predictive value (PPV), negative predictive value (NPV), and accuracy of VeriSee GLC for screening glaucoma suspects(1 Day)
- Accuracy of detection for 3 glaucomatous signs(1 Day)
- Dice coefficient of disc and cup contours(1 Day)