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Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03078231
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : July 30, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Eyenuk, Inc.

Brief Summary:
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF injections if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. This study is designed to assess the performance of EyeArt, an automated DR screening tool.

Condition or disease Intervention/treatment
Diabetic Retinopathy Procedure: Color fundus photography Drug: Mydriatic Agent

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
Actual Study Start Date : February 17, 2017
Actual Primary Completion Date : April 24, 2017
Actual Study Completion Date : April 24, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Color fundus photography
    Subjects will undergo fundus photography before and after administration of mydriatic agent.
  • Drug: Mydriatic Agent
    Subjects will be administered mydriatic medication to dilate their pupils.


Primary Outcome Measures :
  1. Number of subjects whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME). [ Time Frame: 1 visit ]
    The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study subjects will be enrolled at a primary care center
Criteria

Inclusion Criteria:

  • 18 years of age or older;
  • a diagnosis of diabetes mellitus; and
  • understanding of study and provision of written informed consent.

Exclusion Criteria:

  • Persistent visual impairment or sudden vision loss in one or both eyes;
  • History of uncorrected media opacity in one or both eyes;
  • History of retinal vascular disease other than diabetic eye disease;
  • History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract;
  • 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/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 result in ungradable 4-wide field stereoscopic mydriatic fundus photographs.

Information from the National Library of Medicine

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): NCT03078231


Locations
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United States, California
LAC+USC Medical Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Eyenuk, Inc.
National Eye Institute (NEI)
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Responsible Party: Eyenuk, Inc.
ClinicalTrials.gov Identifier: NCT03078231    
Other Study ID Numbers: EN-01p
9SB1EY027241 ( U.S. NIH Grant/Contract )
2R44EY026864 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
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