Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

• Sponsor: Eyenuk, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03078231
• Collaborator: National Eye Institute (NEI) (NIH)
• Enrollment: 52
• Location: 1
• Actual Duration (Months): 2.2
• Patients Per Site Per Month: 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Procedure: Color fundus photography; Drug: Mydriatic Agent

Study Design

• Study Type: Observational
• Actual Enrollment: 52 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
• Actual Study Start Date: Feb 17, 2017
• Actual Primary Completion Date: Apr 24, 2017
• Actual Study Completion Date: Apr 24, 2017

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LAC+USC Medical Center	Los Angeles	California	United States	90033

Sponsors and Collaborators

• Eyenuk, Inc.
• National Eye Institute (NEI)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eyenuk, Inc.
• ClinicalTrials.gov Identifier: NCT03078231
• Other Study ID Numbers: EN-01p; 9SB1EY027241; 2R44EY026864
• First Posted: Mar 13, 2017
• Last Update Posted: Jul 30, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Mydriatics

Study Results

No Results Posted as of Jul 30, 2018