Preliminary Assessment of iCare RETCAD as an Automated Tool for Diabetic Retinopathy Screening

Centervue SpA0 个研究点目标入组 198 人开始时间: 2026年2月1日最近更新: 2026年2月11日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Centervue SpA
入组人数: 198
主要终点: Number of subjects whose results provided by the automatic AI-based tool match the reading center grading for the identification of referable diabetic eye disease (more than mild DR).

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is being done to evaluate the performance of a software that uses artificial intelligence to analyze photographs of the retina to help detect diabetic retinopathy. The study will also assess the safety of the software in combination with a fundus camera already available on the market. This software analyzes retinal photographs to detect more than mild diabetic retinopathy in adults with diabetes. The results will be compared to expert human evaluations.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Cross Sectional

入排标准

年龄范围: 22 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•22 years old or older
•diabetes or diabetic retinopathy
•understand the study information and able to sign a consent form

排除标准

•cannot tolerate eye imaging tests
•laser treatment or injections
•eye surgery, except for simple cataract surgery
•currently involved in another study
•cannot or do not want to have your eyes dilated
•photodynamic therapy within the last 90 days

结局指标

主要结局

Number of subjects whose results provided by the automatic AI-based tool match the reading center grading for the identification of referable diabetic eye disease (more than mild DR).

时间窗: 1-day visit

次要结局

percentage of eyes for which the AI-based automatic tool produced a result(1-day visit)

研究者

发起方

Centervue SpA

申办方类型

Industry

责任方

Sponsor

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