Multicenter trial re-analysis demonstrates robust reduction of visual loss with focal photocoagulation in diabetic macular edema, confirming findings despite single-clinic protocol deviations.
To the Editor. —In the December 1985 issue of theArchiveswe published data from the Early Treatment Diabetic Retinopathy Study (ETDRS) that demonstrated that focal photocoagulation of "clinically significant" diabetic macular edema substantially reduces the risk of visual loss.¹As part of the ongoing monitoring of the 23 clinics in this study, we discovered that one of our clinics was not carefully following the study protocol. As a consequence, their data cannot be considered comparable with data from the other clinics. No data from this clinic will be included in any future ETDRS analyses or publications. We have reproduced all of the figures and tables presented in the December 1985 article after deleting the data from this clinic and find essentially no changes in our published results (Table). For example, the Figure shows the comparison of the percentage of eyes that experienced visual loss of 15 or more letters
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Aiello et al. (1987) studied this question.
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