Diabetes
Conditions
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
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.
Interventions
DEVICEEyenez Retinal Camera v200
DEVICEVolk Pictor Ret 1
Sponsors
Eyenez LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Evaluation of Retina Camera Images from both Healthy and Diseased Subjects | up to 1 week | At least 90% of retinal camera images from both retinal cameras will be equivalent |
Outcome results
None listed