跳至主要内容
临床试验/CTRI/2025/10/095657
CTRI/2025/10/095657尚未招募不适用

Automated vs. Manual Screening of Eye Images: A Comparative Study of Artificial Intelligence-Based Diabetic Retinopathy Detection

Divyajyoti Trust1 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2025年10月20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
15,000
试验地点
1
主要终点
The primary outcome of the study appears to be a comparison of the rapidity, quality, and cost of screening fundus photography using two different modalities:

研究概览

简要总结

This is only an observational study. There is no intervention taking place

Hence, safety is not a concern at all

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients above the age of 40 years residing in Umarpada taluka.

排除标准

  • Media opacity Patient denies examination.

结局指标

主要结局

The primary outcome of the study appears to be a comparison of the rapidity, quality, and cost of screening fundus photography using two different modalities:

时间窗: Time PointsThe study will assess these outcomes at specific time points: | 1. Baseline: Initial assessment | 2. 4 weeks: Follow-up assessment | 3. 8 weeks: Final assessment

1. AI-based imaging tool

时间窗: Time PointsThe study will assess these outcomes at specific time points: | 1. Baseline: Initial assessment | 2. 4 weeks: Follow-up assessment | 3. 8 weeks: Final assessment

2. Manual grading by a grader

时间窗: Time PointsThe study will assess these outcomes at specific time points: | 1. Baseline: Initial assessment | 2. 4 weeks: Follow-up assessment | 3. 8 weeks: Final assessment

次要结局

  • 1. Diagnostic Accuracy: Comparison of true positives, false positives, true negatives, & false negatives between AI-based imaging tool & manual grading.(2. Grader Agreement: Inter-grader reliability & agreement between AI-based tool & manual grading.)

研究者

发起方
Divyajyoti Trust
申办方类型
Other [ngo]
责任方
Principal Investigator
主要研究者

Dr Uday Gajiwala

Divyajyoti Trust

研究点 (1)

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