Retinal hemorrhage in retinopathy of prematurity associated with tocopherol treatment.

Two hundred eighty-seven infants were enrolled in a double masked, randomized, placebo controlled trial of early parenteral tocopherol given from day one. Among the 232 survivors with ophthalmologic follow-up, retinal hemorrhages occurred more frequently in the tocopherol group (16/111; 14.4%) than in the placebo group (8/121; 6.6%). The development of retinal hemorrhages correlated strongly with plasma tocopherol levels from three weeks to three months (P less than 0.05). Future studies of tocopherol should be aware of potential bleeding diatheses, and study this prospectively.