Computer Detection of Diabetic Retinopathy Compared to Clinical Examination



Status:Completed
Conditions:Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:April 2012
End Date:September 2012

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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

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.

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.

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
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Cedar Rapids, Iowa 52403
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Cedar Rapids, IA
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Iowa City, IA
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Mesa, Arizona 85206
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Mesa, AZ
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Phoenix, Arizona 85016
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Phoenix, AZ
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