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How Many Steps of Progression of Diabetic Retinopathy Are Meaningful?
The Wisconsin Epidemiologic Study of Diabetic Retinopathy
Arch Ophthalmol. 2001;119:547-553.
Objective To determine whether a 1-step or more or 2-step or more progression
on the Early Treatment Diabetic Retinopathy Study retinopathy severity scale
over a 4-year period is meaningful in predicting the subsequent incidence
of proliferative diabetic retinopathy (PDR) and clinically significant macular
edema (CSME) over the following 6 years.
Design Population-based study of diabetic persons with 10 years of follow-up.
Setting and Patients Eleven-county area in southern Wisconsin. There were 1025 persons with
diabetes who had fundus photographs at baseline and at 4- and 10-year follow-up
examinations.
Main Outcome Measures Incidence of PDR or CSME between the 4- and 10-year follow-up examinations
as determined by masked grading of color stereoscopic fundus photographs of
7 standard fields.
Results In a univariate analysis, those with 1 or more steps of progression
(n = 551) over the first 4 years of the study were significantly (P<.0001) more likely to develop PDR over the next 6 years than those
with no progression (n = 474) (26% vs 4%) (relative risk, 5.85; 95% confidence
interval, 4.05-8.47). Similarly, those with 2 or more (n = 364) (33%) or 3
or more (n = 231) (41%) steps of progression over the first 4 years of the
study were significantly (P<.0001) more likely
to develop PDR over the next 6 years than those with lesser progression (n
= 661 [7%] and n = 794 [9%], respectively) (relative risk, 5.10; 95% confidence
interval, 3.83-6.80; and relative risk, 4.61; 95% confidence interval, 3.57-5.99,
respectively). Similar associations were apparent at every level of retinopathy,
duration of diabetes, and glycosylated hemoglobin, and by type of diabetes
at baseline. There were also associations between retinopathy progression
and incidence of CSME.
Conclusions It seems that 1 or more or 2 or more steps of progression of retinopathy
over a 4-year period strongly predict the development of PDR over the next
6 years. Therefore, using these end points of progression would result in
the need for fewer subjects or shorter follow-up in some clinical trials.
Ronald Klein, MD;
Barbara E. K. Klein, MD;
Scot E. Moss, MA
From the Department of Ophthalmology and Visual Sciences, University
of Wisconsin Medical School, Madison.
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