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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03828890
Collaborator
(none)
36
Enrollment
1
Location
1
Arm
9.1
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Screening eye exam using Optos technology
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
A Pilot Study to Assess Screening for Diabetic Retinopathy Using Retinal Camera in Family Medicine Clinic
Actual Study Start Date :
Jun 12, 2019
Actual Primary Completion Date :
Mar 15, 2020
Actual Study Completion Date :
Mar 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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%.

Other Outcome Measures

  1. Patient Satisfaction [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: 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Jacksonville Florida United States 32224

Sponsors and Collaborators

  • Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bryan Farford, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03828890
Other Study ID Numbers:
  • 18-009449
First Posted:
Feb 4, 2019
Last Update Posted:
Dec 2, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetic Retinopathy

Study Results

No Results Posted as of Dec 2, 2020