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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Color Fundus Photography

Procedure

Subjects will undergo fundus photography before and after administration of mydriatic agent.

Mydriatic Agent

Drug

Subjects will be administered mydriatic medication to dilate their pupils.

Primary outcomes

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).

Time frame: 1 visit

The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures.

Sponsors and collaborators

Lead sponsor

Eyenuk, Inc.

Industry

Collaborators

National Eye Institute (NEI)

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Mar 13, 2017
Registry last updated: Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed