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

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.

Healthy subjects Inclusion Criteria:

• Written Informed Consent
• Male or female
• Age ≥ 18 years and ≤80 years
• Normal Retina

Healthy subjects Exclusion Criteria:

• Glaucoma
• Limited Ability for Agreement
• Spectrum of retinal diseases
• Subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit

Diseased subjects Inclusion Criteria:

• Written Informed Consent
• Male or female
• Age ≥ 18 years and ≤80 years
• Spectrum of retinal diseases

Diseased subjects Exclusion Criteria:

• Normal Retina
• Limited Ability for Agreement
• Subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit