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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-05-31

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.

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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.

Conditions

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Kidney Failure, Chronic Eye Diseases Diabetic Retinopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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RetinaVue 100 camera

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

Group Type OTHER

RetinaVue 100 camera

Intervention Type DEVICE

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.

Interventions

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RetinaVue 100 camera

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.

Intervention Type DEVICE

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.