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

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ClinicalTrials.gov Identifier: NCT03828890
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bryan Farford, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diagnostic Test: Screening eye exam using Optos technology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Estimated Study Start Date : February 28, 2019
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single Arm Trial
Intervention includes screening eye exam using Optos technology
Diagnostic Test: Screening eye exam using Optos technology
Retinal imaging using Optos technology to identify Diabetic Retinopathy




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 [ 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.


Secondary Outcome Measures :
  1. 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%.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


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Responsible Party: Bryan Farford, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03828890     History of Changes
Other Study ID Numbers: 18-009449
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications