Computer Detection of Diabetic Retinopathy Compared to Clinical Examination

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