Complications, Adverse Events, and Additional Intraocular Surgery 1 Year After Cataract Surgery in the Infant Aphakia Treatment Study

Purpose To compare rates and severity of complications between infants undergoing cataract surgery with and without intraocular lens (IOL) implantation. Design Prospective, randomized clinical trial. Participants The Infant Aphakia Treatment Study (IATS) is a randomized, multicenter (n = 12) clinical trial comparing treatment of aphakia with a primary IOL or contact lens in 114 infants with unilateral congenital cataract. Intervention Infants underwent cataract surgery with or without placement of an IOL. Main Outcome Measures The rate, character, and severity of intraoperative complications (ICs), adverse events (AEs), and additional intraocular surgeries (AISs) during the first postoperative year in the 2 groups were analyzed. Results There were more patients with ICs (28% vs. 11%; P = 0.031), AEs (77% vs. 25%; P