Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
Completed
Conditions studied: Diabetic Retinopathy, Diabetic Eye Problems, Diabetic Macular Edema
In brief
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic macular edema (DME) collectively known as 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 treatment 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. EyeArt is an automated screening device designed automatically analyze color fundus photographs of diabetic patients to identify patients with referable or vision threatening DED. This study is designed to assess the safety and efficacy of EyeArt.
Key facts
- Study ID
- NCT03112005
- Run by
- Eyenuk, Inc.
- People needed
- 942
- Starts
- 2017-04-17
- Expected to finish
- 2018-05-31
- Last updated by the study team
- 2018-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A diagnosis of diabetes mellitus;
- Understanding of study and provision of written informed consent; and
- 18 years of age or older.
You may not qualify if…
- Persistent visual impairment in one or both eyes;
- History of macular edema 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 clinical reference standard photographs.
Where it is running
- Los Angeles Biomedical Research Institute — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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