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

Diabetes Clinical Trial

Official title:

Clinical Equivalency Validation Protocol Eyenez v200 and Volk Pictor Ret1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783807
• Other study ID #: 101
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: May 25, 2016
• Start date: October 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Eyenez LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Eyenez Retinal Camera v200

• Volk Pictor Ret 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eyenez LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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