Computer Detection of Diabetic Retinopathy Compared to Clinical Examination

Completed

Conditions studied: Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT01625598

Run by

Digital Diagnostics, Inc.

People needed

600

Starts

2012-04-01

Expected to finish

2014-04-01

Last updated by the study team

2014-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States
• Barnet Dulaney Perkins Eye Center — Phoenix, Arizona, United States
• Iowa Eye Center — Cedar Rapids, Iowa, United States
• University of Iowa Department of Ophthalmology and Visual Sciences — Iowa City, Iowa, United States
• Retina Consultants of Houston — Houston, Texas, United States
• Robert Cizik Eye Clinic - University of Texas Houston — Houston, Texas, United States
• Retina Consultants of Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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