N/A
N=900
A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT02963441 ↗Enrolled (actual)
900
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Sensitivity Corrected for Enrichment — 87.2 percentage of true positives
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- LumineticsCore (formerly IDX-DR) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Digital Diagnostics, Inc.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity Corrected for Enrichment |
87.2 | — |
| PRIMARY Specificity Corrected for Enrichment |
90.7 | — |
| PRIMARY Observed Sensitivity |
87.4 | — |
| PRIMARY Observed Specificity |
89.5 | — |
| PRIMARY Sufficient vs. Insufficient Image Quality Output From IDx-DR |
96.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
- 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
Data sourced from ClinicalTrials.gov (NCT02963441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.