Feasibility Study of Retinal Screening Using the RetinaVue 100 Camera in Outpatient Dialysis Centers

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

The subject must currently be seeking treatment for end-stage renal disease (ESRD) at one of the specified dialysis clinics.
The subject must be ≥ 18 years of age.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
RetinaVue 100 camera	RetinaVue 100 camera	Participants will have a retinal screening completed by study staff using the FDA-approved RetinaVue 100 hand-held camera

Primary Outcome Measures

Name	Time	Method
Usability of the RetinaVue Hand-Held 100 Camera	baseline visit	Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images.

Secondary Outcome Measures

Name	Time	Method
Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population	Baseline and post retinal eye exam	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.
Overall Retinopathy in a Dialysis Population	Post retinal eye exam	Number of participants found to have retinopathy in a dialysis population
Participant Satisfaction	Post retinal eye exam	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.