Clinical Equivalency Validation Protocol Clinical Equivalency Eyenez Retina Camera v200 and Optomed Smartscope M5 EY3
|ClinicalTrials.gov Identifier: NCT02783807|
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : May 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Device: Eyenez Retinal Camera v200 Device: Volk Pictor Ret 1||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Equivalency Validation Protocol Eyenez v200 and Volk Pictor Ret1|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||May 2016|
Experimental: Eyenez Retinal Camera v200
Retinal images from Eyenez Retinal Camera v200 of healthy and diseased subjects
Device: Eyenez Retinal Camera v200
Active Comparator: Volk Pictor Ret 1
Retinal images from Volk Pictor Ret 1 of healthy and diseased subjects
Device: Volk Pictor Ret 1
Other Name: Optimed Smartscope M5 EY3
- Clinical Evaluation of Retina Camera Images from both Healthy and Diseased Subjects [ Time Frame: up to 1 week ]At least 90% of retinal camera images from both retinal cameras will be equivalent
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783807
|Principal Investigator:||Mark Kislinger, PhD MD||Eyenez LLC|