Complications in the First 5 Years Following Cataract Surgery in Infants With and Without Intraocular Lens Implantation 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. Methods A total of 114 infants were enrolled in the Infant Aphakia Treatment Study, a randomized, multi-center (12) clinical trial comparing the treatment of unilateral aphakia in patients under 7 months of age with a primary IOL implant or contact lens. The rate, character, and severity of intraoperative complications, adverse events, and additional intraocular surgeries during the first 5 postoperative years in the 2 groups were examined. Results There were more patients with intraoperative complications (28% vs 11%, P = .031), adverse events (81% vs 56%, P = .008), and more additional intraocular surgeries (72% vs 16%, P Conclusion The increased rate of complications, adverse events, and additional intraocular surgeries associated with IOL implantation in infants