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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility Study of Retinal Screening Using the RetinaVue 100 Hand- Held (Non-mydriatic) Camera in Outpatient Dialysis Centers

Conditions
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Kidney Failure, Chronic, Eye Diseases, Diabetic Retinopathy

Intervention / Treatment
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* Device: RetinaVue 100 camera


Participation Criteria
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Eligibility Criteria
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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: The subject is <18 years of age. No exclusions will be made on the basis of gender, ethnicity, or race.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RetinaVue 100 camera<br>Participants will have a retinal screening completed by study staff using the FDA-approved RetinaVue 100 hand-held camera | Device: RetinaVue 100 camera<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Retinopathy in a Dialysis Population | Number of participants found to have retinopathy in a dialysis population | 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. | 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. | Baseline and post retinal eye exam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal screening, outpatient dialysis