Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

Diabetic Retinopathy Clinical Trial

Official title:

Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078231
• Other study ID #: EN-01p
• Secondary ID: 9SB1EY0272412R44
• Status: Completed
• Start date: February 17, 2017
• Est. completion date: April 24, 2017

Study information

• Verified date: July 2018
• Source: Eyenuk, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 24, 2017
• Est. primary completion date: April 24, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	LAC+USC Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Eyenuk, Inc.	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures.	1 visit