American Diabetes Association
IRISDRPredBlind_DiabetCare_Wykoff_FINALb_Online-Only_Suppl_Materials.pdf (220.3 kB)

Risk of Blindness Among Patients With Diabetes and Newly Diagnosed Diabetic Retinopathy

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posted on 2021-01-20, 17:27 authored by Charles C. Wykoff, Rahul N. Khurana, Quan Dong Nguyen, Scott P. Kelly, Flora Lum, Rebecca Hall, Ibrahim M. Abbass, Anna M. Abolian, Ivaylo Stoilov, Tu My To, Vincent Garmo

To evaluate association between initial diabetic retinopathy (DR) severity/risk of blindness in patients with newly diagnosed DR/good vision in the U.S.


Retrospective cohort study of adult patients with good vision (20/40 or better)/newly diagnosed DR between 1 January 2013 and 31 December 2017 (index date) in the American Academy of Ophthalmology’s IRIS® Registry. Primary exposure of interest, DR severity at index: mild nonproliferative DR (NPDR), moderate NPDR, severe NPDR, proliferative DR (PDR). Main outcome measure: development of sustained blindness (SB), defined as study eyes with Snellen visual acuity readings of 20/200 or worse at two separate visits ≥3 months apart that did not improve beyond 20/100.


Among 53,535 eligible eyes (mean follow-up, 662.5 days), 678 (1.3%) eyes developed SB. Eyes with PDR at index represented 10.5% (5,629/53,535) of the analysis population but made up 26.5% (180/678) of eyes that developed SB. Kaplan-Meier analysis revealed that eyes with moderate NPDR, severe NPDR, and PDR at index were 2.6, 3.6, and 4.0 times more likely, respectively, to develop SB after 2 years of DR diagnosis versus eyes with mild DR at index. In a Cox proportional hazards model adjusted for index characteristics/development of ocular conditions during follow-up, eyes with PDR had an increased risk of developing SB versus eyes with mild NPDR at index (hazard ratio, 2.26; 95% CI, 2.09−2.45).


In this longitudinal ophthalmologic registry population involving eyes with good vision, more advanced DR at first diagnosis was a significant risk factor for developing SB.


Funding for the study was provided by Genentech, Inc., South San Francisco, CA. Genentech, Inc. employees participated in design and conduct of the study; analysis and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. Third-party writing assistance was provided by Betsy C. Taylor, PhD, CMPP, of Envision Pharma Group and funded by Genentech, Inc.


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