RetinaVue Diabetic Screening

NCT03343730 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-07-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Bassett Healthcare

    lead OTHER

Principal Investigators

  • james Dalton, MD · Bassett Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2018-10-01
Completion
2018-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03343730 on ClinicalTrials.gov