NCT01625598

Computer Detection of Diabetic Retinopathy Compared to Clinical Examination

A Multicenter Masked Study to Compare Analysis of the Detection Program IDx-DR Against Standard of Care Clinical Examination by Ophthalmologists to Differentiate Levels of Diabetic Retinopathy and Diabetic Macular Edema

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Digital Diagnostics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis is that computer detection of the severity of diabetic retinopathy including the presence of clinically significant macular edema is not inferior to the detection using a dilated eye examination by a Board-certified ophthalmologist.

Detailed description

The project is a multicenter, observational study to compare the accuracy of the IDX-DR computer detection system to board certified ophthalmologists performing dilated eye examination at identifying between no or mild NPDR without clinically significant diabetic macular edema from more than mild NPDR with or without CSDME. Approximately 400-600 persons with diabetes will be recruited through 5 clinical centers. The ophthalmologist who examines the patient will evaluate and record the status of the eye based on his/her clinical examination. The study subjects will then have two fundus photographs taken of each eye. The photographic images will be transferred to a central Reading Center at the University of Pennsylvania and interpreted by professional graders. The Reading Center will then transfer the images to IDx-DR, the computer detection system. IDx-LLC, the Sponsor of this study, will have no access to the images. Data from the Reading Center interpretation will be considered the "gold standard". The results of the clinical examination and IDX-DR will be compared against this gold standard as well as against each other.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
PROCEDURE	Photography of the retina	Every subject will undergo photography of the retina in both eyes
PROCEDURE	Retinal photography	Device Subjects will have photography of both eyes

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-06-21
• Last updated: 2014-04-22

Locations

7 sites across 1 country: United States