Diabetic Retinopathy Clinical Trial
Official title:
Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
Verified date | July 2018 |
Source | Eyenuk, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 942 |
Est. completion date | May 31, 2018 |
Est. primary completion date | May 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - A diagnosis of diabetes mellitus; - Understanding of study and provision of written informed consent; and - 18 years of age or older. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Los Angeles Biomedical Research Institute | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Eyenuk, Inc. | National Eye Institute (NEI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subject eyes 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). | The performance of EyeArt will be evaluated using sensitivity and specificity measures. | 1 visit (1 day) | |
Primary | Number of subject eyes whose EyeArt results match the reading center grading for identifying vision threatening diabetic eye disease (severe NPDR or PDR or surrogate markers for CSME). | The performance of EyeArt will be evaluated using sensitivity and specificity measures. | 1 visit (1 day) |
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