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临床试验/CTRI/2025/10/096073
CTRI/2025/10/096073尚未招募不适用

Comparison of the DRISTi -Artificial Intelligence System with Ophthalmologists’ Grading for Diabetic Retinopathy Detection

Artelus Pvt Ltd1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2025年11月1日最近更新:

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

发起方
Artelus Pvt Ltd
申办方类型
Other [Med Tech company]
责任方
Principal Investigator
主要研究者

Dr Jyothsna Rajagopal

ARTELUS-Artificial Learning Systems India Private Limited,

研究点 (1)

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