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Thomas P. Karnowski et al.

minimal disease). Category 2 validation should be able to accurately determine if sight-threatening DR including any level of macular edema, ETDRS level 53 (or worse), or proliferative DR is present. Category 2 validation distinguishes patients with sight-threatening DR who require prompt referral for possible laser surgery. Category 3 validation applies to a system that can distinguish ETDRS-defined levels of nonproliferative DR (mild, moderate, or severe), proliferative DR (early, high-risk), and macular edema with accuracy sufficient to determine appropriate follow-up and treatment strategies (equivalent to a retinal examination through dilated pupils). Category 4 validation applies to a system that matches or exceeds the ability of the ETDRS photos to determine levels of DR. Ultimately, we believe that the CBIR method has the potential to perform at a Category 3 validation level to stratify and effectively manage DR at an expert level using nonmydriatic images taken in the primary care setting.

Acknowledgments

These studies were supported in part by grants from Oak Ridge National Laboratory, the National Eye Institute (EY017065), the Health Resources and ServicesAdministration, by an unrestricted UTHSC Departmental grant from Research to Prevent Blindness, New York, NY, Fight for Sight, New York, NY, and by The Plough Foundation, Memphis, TN.

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