Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic
A Pilot Study to Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic
1 other identifier
interventional
36
1 country
1
Brief Summary
The long-term goal for this study is to improve compliance of screening for diabetic retinopathy among subjects with diabetes. Researchers are also doing this research to determine the ability of appropriately trained family physicians to screen for and identify Diabetic Retinopathy using a retinal camera in addition to determining an overall patient perspective of the convenience and cost-effectiveness of retinal imaging within a primary care setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus
Started Jun 2019
Shorter than P25 for not_applicable diabetes-mellitus
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
January 16, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedStudy Start
First participant enrolled
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedDecember 2, 2020
November 1, 2020
9 months
January 16, 2019
November 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Family Physicians Screening for Diabetic Retinopathy - Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist
Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist. These photographs are obtained using retinal imaging and after the initial read by the family physicians trained to interpret the images, the images will be reviewed by the retinal specialist to determine if the interpreted results are accurate.
6 months.
Secondary Outcomes (1)
Screening Impact - Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging.
6 months
Other Outcomes (1)
Patient Satisfaction
6 months
Study Arms (1)
Single Arm Trial
OTHERIntervention includes screening eye exam using Optos technology
Interventions
Retinal imaging using Optos technology to identify Diabetic Retinopathy
Eligibility Criteria
You may qualify if:
- Patient ≥ 18 years of age
- Diabetes Mellitus Type I or II
- Patient is willing and able to provide informed written consent
You may not qualify if:
- Known Diabetic Retinopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Jacksonville, Florida, 32224, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bryan Farford, D.O.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 16, 2019
First Posted
February 4, 2019
Study Start
June 12, 2019
Primary Completion
March 15, 2020
Study Completion
March 15, 2020
Last Updated
December 2, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share