Assessment of EyeArt Performance With Retinal Imaging Devices

• Sponsor: Eyenuk, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04302012
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 26.6

Study Details

Study Description

Brief Summary

The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using multiple retinal imaging devices and operators.

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

Study Design

• Study Type: Observational
• Actual Enrollment: 62 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Assessment of EyeArt Performance With Retinal Imaging Devices
• Actual Study Start Date: Dec 18, 2019
• Actual Primary Completion Date: Feb 27, 2020
• Actual Study Completion Date: Feb 27, 2020

Outcome Measures

Primary Outcome Measures

1. Agreement between multiple EyeArt operations [1 visit (1 day)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• A diagnosis of diabetes mellitus;

• Understanding of study and provision of written informed consent; and

• 22 years of age or older.

Exclusion Criteria:

• Persistent visual impairment in one or both eyes;

• History of macular edema, severe non-proliferative retinopathy, proliferative retinopathy, or retinal vascular (vein or artery) occlusion;

• History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;

• Subject is contraindicated for fundus photography (for example, has light sensitivity);

• 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 or 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 may result in ungradable dilated fundus photographs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lundquist Institute	Los Angeles	California	United States	90502

Sponsors and Collaborators

• Eyenuk, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eyenuk, Inc.
• ClinicalTrials.gov Identifier: NCT04302012
• Other Study ID Numbers: EN-01a
• First Posted: Mar 10, 2020
• Last Update Posted: Jul 8, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Diabetic Retinopathy; Mydriatics

Study Results

No Results Posted as of Jul 8, 2021