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OpenTrials
Completed

NCT Number: NCT04984200

Assessment of EyeArt Performance With Retinal Cameras

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

Rocky Mountain Diabetes Center

Idaho Falls, Idaho, 83404, 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 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

retinal imaging

Procedure

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

Mydriatic Agent

Drug

Subjects will be administered mydriatic medication to dilate their pupils.

Primary outcomes

  1. Overall agreement between the results from multiple EyeArt operations

    Time frame: 1 visit (1 day)

    Overall agreement is defined as the fraction of cases where the multiple EyeArt operation results agree with each other.

Sponsors and collaborators

Lead sponsor

Eyenuk, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 30, 2021
Registry last updated
Nov 9, 2022

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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