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<0.0001), and AISs (63% vs. 12%; P<0.0001) in the IOL group than the contact lens group. Iris prolapse was the most common IC. The most common AE was visual axis opacification, and the most common additional intraocular reoperation was a clearing of visual axis opacification. Conclusions: The rates of ICs, AEs, and AISs 1 year after surgery were numerically higher in the IOL group, but their functional impact does not clearly favor either treatment group.
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