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

November 30, 2020 updated by: Bryan Farford, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm Trial
Intervention includes screening eye exam using Optos technology
Other: Screening eye exam using Optos technology
Retinal imaging using Optos technology to identify Diabetic Retinopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family Physicians Screening for Diabetic Retinopathy - Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist
Time Frame: 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.
6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening Impact - Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging.
Time Frame: 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%.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 6 months

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:

  1. Did you find the Retinal Imaging an easy/efficient way of screening for eye disease as a result of having diabetes? Yes/No

  2. If you had to pay for this out-of-pocket what is the maximum amount you would be willing to pay?

    1. $25
    2. $50
    3. $75
    4. $100
    5. >$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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Bryan Farford, D.O., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Actual)

March 15, 2020

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

January 16, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-009449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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