Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

NCT03112005 | Completed FDA Device

• 3 other identifiers: EN-019SB1EY0272412R44EY026864
• Study Type: observational
• Target: 942
• 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 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.

Conditions

Diabetic Retinopathy; Diabetic Eye Problems; Diabetic Macular Edema

Keywords

Diabetic Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects will be enrolled at eye care practices and primary/diabetes care practices

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 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.

Sponsors & Collaborators

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

Study Sites (1)

Los Angeles Biomedical Research Institute

Los Angeles, California, 90502, 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: April 7, 2017
• First Posted: April 13, 2017
• Study Start: April 17, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

US (1)