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

NCT02783807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-05-26

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

Eyenez Retinal Camera v200

DEVICE

Volk Pictor Ret 1

Sponsors & Collaborators

  • Eyenez LLC

    lead INDUSTRY

Principal Investigators

  • Mark Kislinger, PhD MD · Eyenez LLC

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-03-31
Completion
2016-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02783807 on ClinicalTrials.gov