Computer Detection of Diabetic Retinopathy Compared to Clinical Examination (CDDR)

Digital Diagnostics

Status: Completed

Conditions: Diabetic Retinopathy

Treatments: Procedure: Retinal photography; Procedure: Photography of the retina

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01625598

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• a diagnosis of diabetes mellitus
• subject understands study and has signed informed consent
• no history of any other retinal vascular disease, glaucoma, or other disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed);
• other than cataract surgery, no history of intraocular surgery, ocular laser treatments for any retinal disease, or ocular injections for diabetic macular edema or proliferative disease
• no media opacity precluding good retinal photography
• age 18 or older

Exclusion criteria

• no diagnosis of diabetes mellitus
• potential subject cannot understand study or informed consent
• a history of retinal vascular disease other than due to diabetic retinopathy, glaucoma, or other disease that may affect the appearance of the retina or optic disc
• previous intraocular surgery other than cataract; previous laser to the retina; or previous intraocular injections for the treatment of diabetic retinopathy
• a media opacity in either eye that is severe enough to preclude good retinal photography

Trial design

600 participants in 1 patient group

People with diabetes

Description:

People with diabetes who are referred to an ophthalmologist for a dilated eye examination

Treatment:

Procedure: Photography of the retina

Procedure: Retinal photography