RetinaVue Diabetic Screening

NCT ID: NCT03343730

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2018-10-01

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.

Conditions

Diabetic Retinopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Non-mydriatic color fundus photography

All participants will receive Non-mydriatic color fundus photography with the RetinaVue camera at an already scheduled annual physical exam or follow up clinic visit with their primary care provider (PCP).

Group Type: EXPERIMENTAL

Non-mydriatic color fundus photography with the RetinaVue camera

Intervention Type: DIAGNOSTIC_TEST

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.

Standard of Care (Control)

All patients will also receive a referral for a dilated eye exam with an eye care professional. A yearly dilated exam as referred by the PCP.

Group Type: ACTIVE_COMPARATOR

Referral for dilated eye exam with an eye care professional

Intervention Type: DIAGNOSTIC_TEST

All patients will be given a referral to an eye care professional for a routine, dilated, diabetic eye exam.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bassett Healthcare

OTHER

Sponsor Role: lead

Responsible Party

James Dalton

Attending Physician - Primary Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

james Dalton, MD

Role: PRINCIPAL_INVESTIGATOR

Bassett Medical Center

Locations

Bassett Medical Center

Cooperstown, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

jennifer Victory, RN

Role: CONTACT

jennifer.victory@bassett.org

6075476965

Julie Tirrell, RN

Role: CONTACT

julie.tirrel@bassett.org

6075476563

Facility Contacts

jennifer Victory, RN

Role: primary

jennifer.victory@bassett.org

607-547-6965

Other Identifiers

2078

Identifier Type: -

Identifier Source: org_study_id