A single-center, single-arm, retrospective pivotal trial to evaluate the efficacy of artificial intelligence-based fundus photography analysis software ‘VUNO Med – Fundus AI’

Vuno0 个研究点目标入组 1,713 人开始时间: 待定最近更新: 2020年4月21日

试验速览

暂无简介。

•1) Adults at the age 19 or above who received the fundus examination within the period from July 2016 to June 2018
•2) When an abnormal finding in the fundus image can be confirmed based on the physical examination result or medical records
•*If the subject received the fundus examination more than 2 times, only the first examination result is included.
•- Up to 1713 images [269 images without an abnormal finding and 1444 images with an abnormal finding (including those with 2 or more abnormal findings)]
•-When the clinical study is conducted, the actual number of fundus images collected will not exceed the maximum number since the fundus image database will be built per abnormal finding type. That is, a fundus image without a certain abnormal finding type can be included as a fundus image without other abnormal findings except the certain finding.

•1) When a fundus image is not suitable for reading because there are serious cataracts or corneal opacities in the eye from which the fundus image was taken
•2) Those who are otherwise considered by the investigator to be not suitable for participating in the study

发起方

Vuno