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

NCT02823600 | Completed Results

• 1 other identifier: 16-1116
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Failure, Chronic; Eye Diseases; Diabetic Retinopathy

Keywords

retinal screening; outpatient dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Retinopathy in a Dialysis Population

  Post retinal eye exam

• Participant Satisfaction

  Post retinal eye exam

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

  Baseline and post retinal eye exam

Study Arms (1)

RetinaVue 100 camera

OTHER

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

Device: RetinaVue 100 camera

Interventions

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.

RetinaVue 100 camera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The subject is \<18 years of age.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Welch Allyn: collaborator

Study Sites (1)

UNC Ophthalmology

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Eye Diseases; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations included small sample size which led to low power.

Results Point of Contact

• Title: Seema Garg, MD, PhD
• Organization: University of North Carolina at Chapel Hill

sgarg@med.unc.edu, ashton.madison@alumni.duke.edu

919-966-5296

Study Officials

• Seema Garg, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 20, 2018
• Results First Posted: July 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)