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NCT Number: NCT02823600

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

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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Key information

Conditions

Kidney Failure, Chronic Cardiovascular Diseases Chronic Disease Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Disease Attributes Endocrine System Diseases Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Retinal Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Ophthalmology

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RetinaVue 100 camera

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.

Primary outcomes

  1. Usability of the RetinaVue Hand-Held 100 Camera

    Time frame: 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 outcomes

  1. Overall Retinopathy in a Dialysis Population

    Time frame: Post retinal eye exam

    Number of participants found to have retinopathy in a dialysis population

  2. Participant Satisfaction

    Time frame: 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.

  3. Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Welch Allyn

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 6, 2016
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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