Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

NCT ID: NCT03078231

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-17
• Study Completion Date: 2017-04-24

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.

Conditions

Diabetic Retinopathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Color fundus photography

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

Intervention Type: PROCEDURE

Mydriatic Agent

Subjects will be administered mydriatic medication to dilate their pupils.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Eyenuk, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LAC+USC Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

9SB1EY027241

Identifier Type: NIH

Identifier Source: secondary_id

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2R44EY026864

Identifier Type: NIH

Identifier Source: secondary_id

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EN-01p

Identifier Type: -

Identifier Source: org_study_id