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

NCT02963441 | Completed Results

• 1 other identifier: IDx-DR1, version 03
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Retinopathy

Keywords

Diabetic Retinopathy; Diabetic Macular Edema; Center-involved Diabetic Macular Edema; Clinically Significant Diabetic Macular Edema

Outcome Measures

Primary Outcomes (5)

• Sensitivity Corrected for Enrichment

  Sensitivity corrected for enrichment using logistic regression

  Day 1

• Specificity Corrected for Enrichment

  Specificity corrected for enrichment using logistic regression

  Day 1

• Observed Sensitivity

  The sensitivity observed without adjustment by logistic regression

  Day 1

• Observed Specificity

  The specificity observed without adjustment by logistic regression

  Day 1

• Sufficient vs. Insufficient Image Quality Output From IDx-DR

  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)

  Day 1

Study Arms (1)

DME

Center-involved macular edema based on WRC of macular Optical Coherence Tomography images Clinically Significant macular edema based on WRC grading of widefield stereo color fundus photographs. Sample Size: \~45 subjects with DME

Device: LumineticsCore (formerly IDX-DR)

Interventions

LumineticsCore (formerly IDX-DR) DEVICE

Prospective analysis on an existing subgroup of subjects in the US pivotal study, version 01 and version 02.

DME

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic - sampling method: non-probability sequential, invitation to volunteer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Digital Diagnostics, Inc.: lead

Related Publications (1)

• Abramoff MD, Lavin PT, Birch M, Shah N, Folk JC. Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices. NPJ Digit Med. 2018 Aug 28;1:39. doi: 10.1038/s41746-018-0040-6. eCollection 2018.

  PMID: 31304320 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: IDx President, Dr. Michael Abramoff
• Organization: IDx LLC

info@eyediagnosis.net

319-248-5620

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 15, 2016
• Study Start: January 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 7, 2024
• Results First Posted: May 28, 2021

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share