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

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening eye exam using Optos technology
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm Trial

Arm Description

Intervention includes screening eye exam using Optos technology

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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%.

Full Information

First Posted
January 16, 2019
Last Updated
November 30, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03828890
Brief Title
Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic
Official Title
A Pilot Study to Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm Trial
Arm Type
Other
Arm Description
Intervention includes screening eye exam using Optos technology
Intervention Type
Other
Intervention Name(s)
Screening eye exam using Optos technology
Intervention Description
Retinal imaging using Optos technology to identify Diabetic Retinopathy
Primary Outcome Measure Information:
Title
Family Physicians Screening for Diabetic Retinopathy - Number of photographs that are interpreted accurately by the family physicians when compared to the retinal specialist
Description
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.
Time Frame
6 months.
Secondary Outcome Measure Information:
Title
Screening Impact - Percentage increase in the screening rates for Diabetic Retinopathy using retinal imaging.
Description
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%.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Patient Satisfaction
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Farford, D.O.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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