NCT02823600

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Kidney Failure, Chronic
• Eye Diseases
• Diabetic Retinopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-07-06
• Last updated: 2018-07-20
• Results posted: 2018-07-20

Locations

1 site across 1 country: United States