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

July 19, 2018 updated by: University of North Carolina, Chapel Hill

A Feasibility Study of Retinal Screening Using the RetinaVue 100 Hand- Held (Non-mydriatic) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline visit

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Welch Allyn

Investigators

  • Principal Investigator: Seema Garg, MD, PhD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (ESTIMATE)

July 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-1116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eye Diseases

Clinical Trials on RetinaVue 100 camera

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe