ASPIRIN EFFECTS ON THE DEVELOPMENT OF CATARACTS IN PATIENTS WITH DIABETES-MELLITUS - EARLY TREATMENT DIABETIC-RETINOPATHY STUDY REPORT .16.

The Early Treatment Diabetic Retinopathy Study, a randomized clinical trial supported by the National Eye Institute, was designed to assess the effect of photocoagulation and aspirin in 3711 patients with mild to severe nonproliferative or early proliferative diabetic retinopathy. Although the primary goal of the study was to evaluate the effect of photocoagulation and aspirin on diabetic retinopathy, the study also provided an opportunity to evaluate the effects of aspirin on the development of cataract. No evidence showed that aspirin use reduced the risk of development of cataract requiring extraction (4.1% vs 4.3% in patients assigned to aspirin or placebo treatment, respectively; Mantel-Cox P = .77; relative risk, 1.05; 99% confidence interval, 0.73 to 1.51). Aspirin use also did not reduce the risk of less extensive but visually significant lens opacities developing (29.6% vs 28.3%; Mantel-Cox P = .76; relative risk, 0.99; 99% confidence interval, 0.85 to 1.15). Early Treatment Diabetic Retinopathy Study results do not support the hypothesis that aspirin (at a dose of 650 mg/d) reduces the risk of cataract development in this diabetic population.