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

Clinical Equivalency Validation Protocol Eyenez v200 and Volk Pictor Ret1

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Eyenez Retinal Camera v200; Device: Volk Pictor Ret 1

Detailed Description

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
• Enrollment (Actual): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Optimed Smartscope M5 EY3

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eyenez LLC
• Investigators: Principal Investigator: Mark Kislinger, PhD MD, Eyenez LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Estimate): May 26, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 101 (Other Identifier: Hamilton Integrated Research Ethics Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 510k Submission