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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823600
• Other study ID #: 16-1116
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• The subject is <18 years of age.

• No exclusions will be made on the basis of gender, ethnicity, or race.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Eye Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	UNC Ophthalmology	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Welch Allyn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Retinopathy in a Dialysis Population	Number of participants found to have retinopathy in a dialysis population	Post retinal eye exam
Secondary	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
Secondary	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