A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
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ClinicalTrials.gov Identifier: NCT02963441 |
Recruitment Status :
Completed
First Posted : November 15, 2016
Results First Posted : May 28, 2021
Last Update Posted : May 28, 2021
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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 |
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Diabetic Retinopathy |

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 |

- Sensitivity Corrected for Enrichment [ Time Frame: Day 1 ]Sensitivity corrected for enrichment using logistic regression
- Specificity Corrected for Enrichment [ Time Frame: Day 1 ]Specificity corrected for enrichment using logistic regression
- Observed Sensitivity [ Time Frame: Day 1 ]The sensitivity observed without adjustment by logistic regression
- Observed Specificity [ Time Frame: Day 1 ]The specificity observed without adjustment by logistic regression
- 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)

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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 |
Inclusion Criteria:
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Documented diagnosis of diabetes mellitus, e.g.:
- Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
- 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
- Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
- Age 22 or older
- Understand the study and volunteer to sign the informed consent
Exclusion Criteria:
- Persistent vision loss, blurred vision, or floaters.
- Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
- History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
- Currently participating in another investigational eye study and actively receiving investigational product for DR or DME.
- 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).
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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
Documents provided by IDx LLC:
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 |
Diabetic Retinopathy Macular Edema |
Retinal Diseases Diabetic Retinopathy Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |