Recruiting

RetinaVue

Sponsor:

Bassett Healthcare

Code:

NCT03343730

Conditions

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-mydriatic color fundus photography with the RetinaVue camera

Referral for dilated eye exam with an eye care professional

Study Details

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.

Conditions

Diabetic Retinopathy

Study ID

NCT03343730

Start date

Feb 27, 2018

Status verified date

Jul, 2018

Completion date

Oct 1, 2018

Anticipated

Primary completion date

Oct 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 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).

active comparator: 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.

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.

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.

Primary outcome measure

  • Rate of Diabetic Retinopathy Detection [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

jennifer Victory, RN

6075476965jennifer.victory@bassett.org

Julie Tirrell, RN

6075476563julie.tirrel@bassett.org

Locations

Bassett Medical Center

Recruiting

Cooperstown, New York, United States, 13326

Contacts

jennifer Victory, RN

607-547-6965jennifer.victory@bassett.org

Principal Investigator:

james dalton, MD

More Information

Sponsor

Bassett Healthcare

Last update posted

Jul 11, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bassett Healthcare on 2018-07-11.