Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF injections if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. This study is designed to assess the performance of EyeArt, an automated DR screening tool.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Procedure: Color fundus photography; Drug: Mydriatic Agent

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • LAC+USC Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study subjects will be enrolled at a primary care center

Description

Inclusion Criteria:

• 18 years of age or older;
• a diagnosis of diabetes mellitus; and
• understanding of study and provision of written informed consent.

Exclusion Criteria:

• Persistent visual impairment or sudden vision loss in one or both eyes;
• History of uncorrected media opacity in one or both eyes;
• History of retinal vascular disease other than diabetic eye disease;
• History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract;
• Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
• Subject is currently enrolled in an interventional study of an investigational device/drug; or
• Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or result in ungradable 4-wide field stereoscopic mydriatic fundus photographs.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME).	The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures.	1 visit

Collaborators and Investigators

• Sponsor: Eyenuk, Inc.
• Collaborators: National Eye Institute (NEI)

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2017
• Primary Completion (Actual): April 24, 2017
• Study Completion (Actual): April 24, 2017

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Mydriatics
• Other Study ID Numbers: EN-01p; 9SB1EY027241 (U.S. NIH Grant/Contract); 2R44EY026864 (U.S. NIH Grant/Contract)