Assessment of EyeArt Performance With Retinal Imaging Devices
1 other identifier
observational
62
1 country
1
Brief Summary
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using multiple retinal imaging devices and operators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2020
CompletedFirst Submitted
Initial submission to the registry
March 6, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedJuly 8, 2021
July 1, 2021
2 months
March 6, 2020
July 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Agreement between multiple EyeArt operations
1 visit (1 day)
Interventions
Subjects will undergo fundus photography before and/or after administration of mydriatic agent
Subjects may be administered mydriatic medication to dilate their pupils.
Eligibility Criteria
Study subjects will be enrolled at primary care and/or eye care centers
You may qualify if:
- A diagnosis of diabetes mellitus;
- Understanding of study and provision of written informed consent; and
- years of age or older.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eyenuk, Inc.lead
Study Sites (1)
Lundquist Institute
Los Angeles, California, 90502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2020
First Posted
March 10, 2020
Study Start
December 18, 2019
Primary Completion
February 27, 2020
Study Completion
February 27, 2020
Last Updated
July 8, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share