RetinaVue Diabetic Screening
Diabetic Retinopathy Screening With Non-mydriatic Color Fundus Camera in the Primary Care Clinic
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
February 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJuly 11, 2018
July 1, 2018
7 months
November 13, 2017
July 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Diabetic Retinopathy Detection
This study will examine the rate of detection of diabetic retinopathy using an in-clinic retinal camera and standard referral to eye care professional for dilated eye exam
3 months
Study Arms (2)
Non-mydriatic color fundus photography
EXPERIMENTALAll 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).
Standard of Care (Control)
ACTIVE COMPARATORAll 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
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.
All patients will be given a referral to an eye care professional for a routine, dilated, diabetic eye exam.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Type II diabetes without documented diabetic retinopathy
You may not qualify if:
- Documented ocular pathology that may interfere with image acquisition (i.e. high grade cataract)
- Macular pathology (i.e. macular degeneration, cystoid macular edema, central serous retinopathy)
- Inability to attain analyzable RetinaVue image due to ocular pathology or other conditions (such as tremors limiting ability to maintain stable head for image)
- Acute or emergent ocular pathology that requires urgent assessment by an eye care professional as identified by the RetinaVue camera interpretation report
- Seen within the last 11 months for a diabetic eye exam.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bassett Medical Center
Cooperstown, New York, 13326, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
james Dalton, MD
Bassett Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician - Primary Care
Study Record Dates
First Submitted
November 13, 2017
First Posted
November 17, 2017
Study Start
February 27, 2018
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
July 11, 2018
Record last verified: 2018-07