RetinaVue Diabetic Screening

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.

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.