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

May 25, 2016 updated by: Eyenez LLC

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: up to 1 week
At least 90% of retinal camera images from both retinal cameras will be equivalent
up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyenez LLC

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Hamilton Integrated Research Ethics Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

510k Submission

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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