Assessment of EyeCheckup as an Automated Diabetic Retinopathy Screening Tool

Summary

Participation Requirements

Description

This is a prospective study to assess the safety and efficacy of EyeCheckup in screening for DR. This study is a single-center observational study with primary endpoints to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy in the primary care setting. After exclusions, ...

This is a prospective study to assess the safety and efficacy of EyeCheckup in screening for DR. This study is a single-center observational study with primary endpoints to determine the sensitivity and specificity of EyeCheckup to diabetic retinopathy in the primary care setting. After exclusions, this study will enroll up to 900 subjects who are diagnosed with diabetes by the endocrinology polyclinic and meet the eligibility criteria. Participants who meet the eligibility criteria will be recruited after obtaining written informed consent from primary health care providers. Subjects will undergo fundus photography per, Food and Drug Administration (FDA) cleared, ophthalmic cameras (product code: HKI). Images will be taken according to a specific EyeCheckup imaging protocol provided to the ophthalmic camera operator and then analyzed by the EyeCheckup device. The photography protocol consists of two images of the ocular fundus (one optic disc nerve centered, one macula centered), obtained from both eyes of enrolled participants. After the retinal images taken from ophthalmic cameras (product code: HKI), images are analyzed with EyeCheckup and a scan report is prepared. If it is necessary to enlarge the pupils, eye enlarging eye drops are applied and wait 15-30 minutes. This information is noted. DR is diagnosed by examination by a retina specialist with the captured images. EyeCheckup success rate is calculated by comparing both reports. The secondary purposes of the study are to prove that our product detects the presence of diabetic retinopathy.

Tracking Information