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

Diabetes Mellitus Clinical Trial

Official title:

A Pilot Study to Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03828890
• Other study ID #: 18-009449
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: November 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy

Intervention

Other:
• Screening eye exam using Optos technology
Retinal imaging using Optos technology to identify Diabetic Retinopathy

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction	Percentage change in patient satisfaction and how much are patients willing to pay out of pocket to screen for Diabetic Retinopathy using retinal imaging. Each patient will be surveyed and these questions will help determine patient satisfaction and their willingness to pay for this versus usual care. We will ask the following questions: Did you find the Retinal Imaging an easy/efficient way of screening for eye disease as a result of having diabetes? Yes/No; If you had to pay for this out-of-pocket what is the maximum amount you would be willing to pay?; $25; $50; $75; $100; >$100 This will help us determine the patient's level of satisfaction and their willingness to pay out of pocket for the service.	6 months
Primary	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	Screening Impact - Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging.	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%.	6 months

External Links

•   Mayo Clinic Clinical Trials