Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device

Summary

Participation Requirements

Description

This study is a prospective, multicenter, observational study to assess the safety and efficacy of RETINA-AI Galaxy in screening for diabetic retinopathy in the primary care setting. The study design conforms to an Intent to Screen (ITS) paradigm [1]. The Galaxy is a software medical device designed...

This study is a prospective, multicenter, observational study to assess the safety and efficacy of RETINA-AI Galaxy in screening for diabetic retinopathy in the primary care setting. The study design conforms to an Intent to Screen (ITS) paradigm [1]. The Galaxy is a software medical device designed to analyze digital color fundus photographs and rapidly screen for the presence of more than mild diabetic retinopathy or vision-threatening diabetic retinopathy in the primary care setting. The study will enroll 360 subjects after exclusions. Subjects who meet eligibility criteria will be recruited from three sites staffed by primary care providers. Eligibility will be assessed and informed consent obtained, after which digital color fundus photographs will be taken using U.S. Food and Drug Administration (FDA) cleared non-mydriatic fundus cameras, by an operator using the Galaxy photography manual. There will be a total of 5 non-mydriatic robotic screening cameras used in the AI system protocol part of the study. There will be a dedicated validation camera used in the Validation Reading Center Protocol part of the study. Primary care clinical staff (e.g. medical assistant) with no prior professional ophthalmic photography experience and only a 4 hour training will operate the RETINA-AI Galaxy device and the screening cameras. The Retina Reading Center - certified professional ophthalmic photographers will operate the validation fundus cameras according the the 4W-D stereo protocol.

Tracking Information