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Assessment of EyeArt Performance With Retinal Cameras

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ClinicalTrials.gov Identifier: NCT04984200
Recruitment Status : Completed
First Posted : July 30, 2021
Last Update Posted : November 9, 2022
Sponsor:
Information provided by (Responsible Party):
Eyenuk, Inc.

Study Description
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Brief Summary:
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.

Condition or disease Intervention/treatment
Diabetic Retinopathy Procedure: Retinal imaging Drug: Mydriatic Agent

Study Design
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Study Type : Observational
Actual Enrollment : 246 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of EyeArt Performance With Retinal Cameras
Actual Study Start Date : July 13, 2021
Actual Primary Completion Date : August 19, 2022
Actual Study Completion Date : August 19, 2022

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Groups and Cohorts
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Group/Cohort Intervention/treatment
AB Procedure: Retinal imaging
Subjects will undergo retinal imaging before and/or after administration of mydriatic agent

Drug: Mydriatic Agent
Subjects will be administered mydriatic medication to dilate their pupils.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study subjects will be enrolled at primary care and/or eye care centers
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984200


Locations
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United States, Idaho
Rocky Mountain Diabetes Center
Idaho Falls, Idaho, United States, 83404
Sponsors and Collaborators
Eyenuk, Inc.
More Information
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Responsible Party: Eyenuk, Inc.
ClinicalTrials.gov Identifier: NCT04984200    
Other Study ID Numbers: EN-01b
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs