Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT03078231
• Lead Sponsor: Eyenuk, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-17
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Primary Completion: 2017-04-24
• Study Completion: 2017-04-24
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-26
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	1 visit	The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures.

Trial Locations

Locations (1)

LAC+USC Medical Center; 🇺🇸 Los Angeles, California, United States