Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

NCT03078231 | Completed

• 3 other identifiers: EN-01p9SB1EY0272412R44EY026864
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (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).

  The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures.

  1 visit

Interventions

Color fundus photography PROCEDURE

Subjects will undergo fundus photography before and after administration of mydriatic agent.

Mydriatic Agent DRUG

Subjects will be administered mydriatic medication to dilate their pupils.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study subjects will be enrolled at a primary care center

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eyenuk, Inc.: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Mydriatics

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

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 2, 2017
• First Posted: March 13, 2017
• Study Start: February 17, 2017
• Primary Completion: April 24, 2017
• Study Completion: April 24, 2017
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

US (1)