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OpenTrials
Completed

NCT Number: NCT03828890

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening eye exam using Optos technology

Other

Retinal imaging using Optos technology to identify Diabetic Retinopathy

Primary outcomes

  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 outcomes

  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 outcomes

  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:

    • 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2019
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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