Clinical trial NCT03343730: RetinaVue Diabetic Screening
Official title: Diabetic Retinopathy Screening With Non-mydriatic Color Fundus Camera in the Primary Care Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy
Lead sponsor: Bassett Healthcare
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Type II diabetes without documented diabetic retinopathy

Exclusion Criteria:

1. Documented ocular pathology that may interfere with image acquisition (i.e. high grade cataract)
2. Macular pathology (i.e. macular degeneration, cystoid macular edema, central serous retinopathy)
3. Inability to attain analyzable RetinaVue image due to ocular pathology or other conditions (such as tremors limiting ability to maintain stable head for image)
4. Acute or emergent ocular pathology that requires urgent assessment by an eye care professional as identified by the RetinaVue camera interpretation report
5. Seen within the last 11 months for a diabetic eye exam.

Primary outcomes:
measure: Rate of Diabetic Retinopathy Detection
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
Study officials:
affiliation: Bassett Medical Center
name: james Dalton, MD
role: PRINCIPAL_INVESTIGATOR
References: