Assessment of EyeArt Performance With Retinal Imaging Devices

NCT ID: NCT04302012

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-18

Study Completion Date

2020-02-27

Brief Summary

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

Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Color fundus photography

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

Intervention Type PROCEDURE

Mydriatic Agent

Subjects may be administered mydriatic medication to dilate their pupils.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eyenuk, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lundquist Institute

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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EN-01a

Identifier Type: -

Identifier Source: org_study_id

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