NCT03343730

RetinaVue Diabetic Screening

Diabetic Retinopathy Screening With Non-mydriatic Color Fundus Camera in the Primary Care Clinic

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Bassett Healthcare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

the purpose of this study is to examine whether the deployment of a non-mydriatic color fundus camera in a rural prime care setting is feasible and improves the detection rate of diabetic retinopathy in patients where adherence rates with recommended ophthalmology screening is low.

Detailed description

The Centers for Disease Control and Prevention (CDC) have estimated that 25.6 million Americans aged 20 years or older have either been diagnosed or undiagnosed with diabetes mellitus. As such, it is crucial for patients to receive routine eye exams during their annual health assessment or diabetes follow-up visit with their primary care physician to check for diabetic retinopathy (DR). Of those Type 2 patients with a known duration of diabetes of less than 5 years, DR was diagnosed in 40% of patients taking insulin and 24% of patients not taking insulin. These percentages are especially concerning since data presented by Schoenfeld and colleagues indicates that approximately 35% of Americans with diabetes mellitus do not receive timely and recommended eye care to detect and treat their DR.10 Reasons for noncompliance include transfer to a retinal specialist, limited personal mobility, and insurance. In addition, patients regularly fail to follow-up with their ophthalmologist or optometrist due to the lack of visual symptoms-the lack of symptoms does not exclude the possibility of early diabetic retinopathy. Per the American Diabetes Association (ADA) guidelines, it is recommended that all Type 2 patients receive annual dilated eye exams. These eye exams must be completed by a knowledgeable and experienced eye care professional (i.e. ophthalmologist or optometrist). Early detection of DR and the preventative effects of therapy is an important aspect for long term vision outcomes. The long-term goal is to improve the detection of diabetic retinopathy through better-quality measures of patient compliance and screening protocols in the prime care clinic. It is hypothesized that in type II diabetic patients without documented retinal pathology, a hand-held non-mydriatic fundus camera is superior to a referred dilated eye exams for the screening and detection of DR.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Non-mydriatic color fundus photography with the RetinaVue camera	This hand-held device allows the primary care physician to capture an image of the patient's retina and transmit the image to a board-certified ophthalmologist for interpretation.
DIAGNOSTIC_TEST	Referral for dilated eye exam with an eye care professional	All patients will be given a referral to an eye care professional for a routine, dilated, diabetic eye exam.

Timeline

• Start date: 2018-02-27
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2017-11-17
• Last updated: 2018-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study