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Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

NCT03112005 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 942

Last updated 2018-07-30

No results posted yet for this study

Summary

More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as 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 treatment 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.

EyeArt is an automated screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DED. This study is designed to assess the safety and efficacy of EyeArt.

Conditions

Interventions

PROCEDURE

Color fundus photography

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

DRUG

Mydriatic Agent

Subjects will be administered mydriatic medication to dilate their pupils.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Eyenuk, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2018-05-31
Completion
2018-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03112005 on ClinicalTrials.gov