Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Other: Screening eye exam using Optos technology

• Registration Number: NCT03828890
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Study Start: 2019-06-12
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patient ≥ 18 years of age
• Diabetes Mellitus Type I or II
• Patient is willing and able to provide informed written consent

Exclusion Criteria

• Known Diabetic Retinopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Trial	Screening eye exam using Optos technology	Intervention includes screening eye exam using Optos technology

Primary Outcome Measures

Name	Time	Method
Family Physicians Screening for Diabetic Retinopathy - Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist	6 months.	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.

Secondary Outcome Measures

Name	Time	Method
Screening Impact - Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging.	6 months	Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging using OPTOS when compared with the traditional dilated eye exam.The current screening rate is around 55%.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States