Clinical Equivalency Validation Protocol Clinical Equivalency Eyenez Retina Camera v200 and Optomed Smartscope M5 EY3

Overview

This prospective equivalency study compares the performance of two Ophthalmic Cameras, the Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained technicians will take pictures of the same patients' retinas and the quality of the photos will be evaluated. The study includes healthy patients and patients with a spectrum of retinal diseases. The study requires that technicians take pictures of the retinas of adult patients between 18 and 80 years of age using both the OC and OP. The pictures will be reviewed and compared by a central reader/Ophthalmologist, who will determine if the OC is equivalent to the OP, based on the quality of the images

Subjects (patients) will be recruited via word of mouth. The study duration will be approximately 1-2 weeks, assuming a recruitment rate of 15 subjects per week. The images will be recorded within 15 minutes and will involve minimal disruption to the clinical workflow. In the Study Environment setting (Foothill Medical Offices), the User Interface will be evaluated by comparing retinal pictures taken with subject device OC and predicate device OP. Patient subjects will be given an Information and Consent Form to complete prior to the study The technicians employed by Foothill Eye Clinic will operate the device on patient participants by taking a retinal picture using OC. The technicians will use the predicate device OP to take retinal pictures. The Ophthalmologist will compare the results with the pictures taken by OC and OP. The Ophthalmologist will be blinded to what picture was taken by which camera and record his assessment of the quality for each picture. Patient subjects will receive a standard of care exam with or without dilation.