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A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02963441
Recruitment Status : Completed
First Posted : November 15, 2016
Results First Posted : May 28, 2021
Last Update Posted : May 28, 2021
The Emmes Company, LLC
Information provided by (Responsible Party):

Brief Summary:

Diabetes affects 30.3 million people or 9.3% of the population of the United States. Results of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes patients have some degree of diabetic retinopathy (DR) and that as many as 8% have severe, vision-threatening forms of DR. Early laser photocoagulation in high-risk proliferative diabetic retinopathy (PDR) has been shown to decrease the relative risk of vision loss by as much as 52%. Injections of anti-VEGF agents preserve and improve vision in people with PDR and/or diabetic macular edema. Despite effective treatment however, tens of thousands of people with diabetes are going blind each year largely because they don't undergo annual screening for retinopathy. Currently, less than 50%-60% of people with diabetes have a yearly eye exam and there may not be enough eye specialists to see the balance.

The IDx-DR System is intended for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.

Condition or disease
Diabetic Retinopathy

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 900 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Actual Study Start Date : January 2017
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Sensitivity Corrected for Enrichment [ Time Frame: Day 1 ]
    Sensitivity corrected for enrichment using logistic regression

  2. Specificity Corrected for Enrichment [ Time Frame: Day 1 ]
    Specificity corrected for enrichment using logistic regression

  3. Observed Sensitivity [ Time Frame: Day 1 ]
    The sensitivity observed without adjustment by logistic regression

  4. Observed Specificity [ Time Frame: Day 1 ]
    The specificity observed without adjustment by logistic regression

  5. Sufficient vs. Insufficient Image Quality Output From IDx-DR [ Time Frame: Day 1 ]
    Image-ability, defined as the percentage of participants with a completed reading center grading and a disease level output from the investigational device (IDx-DR)

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic - sampling method: non-probability sequential, invitation to volunteer

Inclusion Criteria:

  1. Documented diagnosis of diabetes mellitus, e.g.:

    1. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
    2. Hemoglobin A1c (HbA1c) ≥ 6.5%
    3. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
    4. Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water
    5. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
  2. Age 22 or older
  3. Understand the study and volunteer to sign the informed consent

Exclusion Criteria:

  1. Persistent vision loss, blurred vision, or floaters.
  2. Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
  3. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
  4. Currently participating in another investigational eye study and actively receiving investigational product for DR or DME.
  5. Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
  6. Participant is contraindicated for imaging by fundus imaging systems used in the study:

    • Participant is hypersensitive to light
    • Participant recently underwent photodynamic therapy (PDT)
    • Participant is taking medication that causes photosensitivity
  Study Documents (Full-Text)

Documents provided by IDx LLC:
Study Protocol  [PDF] August 17, 2017
Statistical Analysis Plan  [PDF] August 20, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IDx LLC
ClinicalTrials.gov Identifier: NCT02963441    
Other Study ID Numbers: IDx-DR1
First Posted: November 15, 2016    Key Record Dates
Results First Posted: May 28, 2021
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by IDx LLC:
Diabetic Retinopathy
Macular Edema
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases