The purpose of this research study is to look at retinal abnormalities in outpatient renal dialysis patients using the FDA approved RetinaVue 100 hand-held (non-mydriatic) camera.
There are no studies evaluating (diabetic or non-diabetic) retinopathy in the renal dialysis patient population (\~300,000 Americans). Approximately 50% of this population has End-stage Retinal Disease (ESRD) due to diabetes. Dialysis patients are among the most debilitated patients, and thus, have even more barriers to receiving their recommended annual retinal evaluation. The advent of the RetinaVue hand-held retinal camera holds great promise in this population, as dialysis patients access medical care 3 times a week, for several hours at a time at their dialysis clinic.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
68
Images of the subject's eye will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit.
UNC Ophthalmology
Chapel Hill, North Carolina, United States
Usability of the RetinaVue Hand-Held 100 Camera
Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images.
Time frame: baseline visit
Overall Retinopathy in a Dialysis Population
Number of participants found to have retinopathy in a dialysis population
Time frame: Post retinal eye exam
Participant Satisfaction
Participant satisfaction survey data to be collected following the completion of retinal eye exam. Participants will be assessed on participant satisfaction measures such as comfort of experience, recovery time, and time invested in undergoing procedure vs. traditional retinal exam methods. The survey utilized a five-point Likert scale with the following responses: (1) strongly agree, (2) agree, (3) neutral, (4) disagree, (5) strongly disagree. The outcome measure is reported percentages for each of the six survey components.
Time frame: Post retinal eye exam
Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population
Changes in eye exam rates of the diabetic subset of total population from baseline (i.e. study entry) and post-enrollment in study. Baseline data were to be obtained from the UNC electronic medical record (EMR) as the number of participants with eye exams within the past year and post data would consist of the number of participants completing a study exam.
Time frame: Baseline and post retinal eye exam
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