Assessment of EyeArt Performance With Retinal Cameras

NCT ID: NCT04984200

Last Updated: 2022-11-09

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

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-13

Study Completion Date

2022-08-19

Brief Summary

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The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras 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

Study Groups

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AB

Retinal imaging

Intervention Type PROCEDURE

Subjects will undergo retinal imaging before and/or after administration of mydriatic agent

Mydriatic Agent

Intervention Type DRUG

Subjects will be administered mydriatic medication to dilate their pupils.

Interventions

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Retinal imaging

Subjects will undergo retinal imaging before and/or 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

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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 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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Rocky Mountain Diabetes Center

Idaho Falls, Idaho, United States

Site Status

Countries

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United States

Other Identifiers

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EN-01b

Identifier Type: -

Identifier Source: org_study_id

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