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

University of North Carolina (UNC)

Status: Completed

Conditions: Eye Diseases; Kidney Failure, Chronic; Diabetic Retinopathy

Treatments: Device: RetinaVue 100 camera

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02823600

16-1116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

68 participants in 1 patient group

RetinaVue 100 camera

Other group

Description:

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

Treatment:

Device: RetinaVue 100 camera