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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Clinical Equivalency Validation Protocol Eyenez v200 and Volk Pictor Ret1

Conditions
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Diabetes

Intervention / Treatment
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* Device: Eyenez Retinal Camera v200
* Device: Volk Pictor Ret 1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eyenez Retinal Camera v200<br>Retinal images from Eyenez Retinal Camera v200 of healthy and diseased subjects | Device: Eyenez Retinal Camera v200<br> <br> |
| Active Comparator: Volk Pictor Ret 1<br>Retinal images from Volk Pictor Ret 1 of healthy and diseased subjects | Device: Volk Pictor Ret 1<br> <br> * Other names: Optimed Smartscope M5 EY3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Evaluation of Retina Camera Images from both Healthy and Diseased Subjects | At least 90% of retinal camera images from both retinal cameras will be equivalent | up to 1 week |