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OpenTrials
Completed

NCT Number: NCT04302012

Assessment of EyeArt Performance With Retinal Imaging Devices

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

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lundquist Institute

Los Angeles, California, 90502, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Color Fundus Photography

Procedure

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

Mydriatic Agent

Drug

Subjects may be administered mydriatic medication to dilate their pupils.

Primary outcomes

  1. Agreement between multiple EyeArt operations

    Time frame: 1 visit (1 day)

Sponsors and collaborators

Lead sponsor

Eyenuk, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2020
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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