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

NCT02783807 | Completed

• 1 other identifier: 101
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Eyenez Retinal Camera v200

EXPERIMENTAL

Retinal images from Eyenez Retinal Camera v200 of healthy and diseased subjects

Device: Eyenez Retinal Camera v200

Volk Pictor Ret 1

ACTIVE COMPARATOR

Retinal images from Volk Pictor Ret 1 of healthy and diseased subjects

Device: Volk Pictor Ret 1

Interventions

Eyenez Retinal Camera v200 DEVICE

Eyenez Retinal Camera v200

Volk Pictor Ret 1 DEVICE

Also known as: Optimed Smartscope M5 EY3

Volk Pictor Ret 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written Informed Consent
• Male or female
• Age ≥ 18 years and ≤80 years
• Normal Retina

You may not qualify if:

• 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
• Written Informed Consent
• Male or female
• Age ≥ 18 years and ≤80 years
• Spectrum of retinal diseases
• 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

Sponsors & Collaborators

• Eyenez LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mark Kislinger, PhD MD

  Eyenez LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 26, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 26, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share