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Trial record 26 of 181 for:    RET

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

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ClinicalTrials.gov Identifier: NCT02783807
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Eyenez LLC

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

Condition or disease Intervention/treatment Phase
Diabetes Device: Eyenez Retinal Camera v200 Device: Volk Pictor Ret 1 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Clinical Equivalency Validation Protocol Eyenez v200 and Volk Pictor Ret1
Study Start Date : October 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

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 Name: Optimed Smartscope M5 EY3




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783807


Sponsors and Collaborators
Eyenez LLC
Investigators
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Principal Investigator: Mark Kislinger, PhD MD Eyenez LLC

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Responsible Party: Eyenez LLC
ClinicalTrials.gov Identifier: NCT02783807     History of Changes
Other Study ID Numbers: 101
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 510k Submission