Comparison of the DRISTi -Artificial Intelligence System with Ophthalmologists’ Grading for Diabetic Retinopathy Detection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Primary outcome measures
研究概览
简要总结
India currently has 101 million people with diabetes, expected to rise to 134 million by 2045. Diabetic retinopathy affects about 35 percent of people with diabetes for over five years. Due to limited eye care access and few ophthalmologists, only a small percentage of diabetics receive regular screening. AI-based tools can help scale DR detection. This study aims to compare the diagnostic performance of Artificial Intelligence System ( called DRISTi) with that of expert ophthalmologists. The primary objective of the study is compare the sensitivity and specificity of DRISTi in detecting Referable Diabetic Retinopathy from fundus images versus ophthalmologist grading.The study is designed as a Retrospective observational study to be done over maximum Three months for data collection, analysis, and reporting. An estimated 2500 images from different non-mydriatic cameras (Crystal Vue, ) will be de-identified and anonymided .This data set will be secure ly stored and garded by both AI and the Ophthalmologist . The opthalmologist will be blinded to AI results. Statistical anlaysis will include snsitivity and specificity in detecting referable DR awith 95 percent confidence intervals .
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •patient visiting hospital for diabetic screening or retinal evaluation.
排除标准
- •Images of patients which are un-gradbale.
结局指标
主要结局
Primary outcome measures
时间窗: only at baseline since this is a cross sectional single observation study
1.Sensitivity and specificity of the DRISTi algorithm for detecting more than Mild DR and vision threartening DR compared to the reference standard
时间窗: only at baseline since this is a cross sectional single observation study
次要结局
未报告次要终点
研究者
Dr Jyothsna Rajagopal
ARTELUS-Artificial Learning Systems India Private Limited,
