Objective-To compare the visual outcomes and adverse events of contact lens to primary intraocular lens (IOL) correction of monocular aphakia during infancy.Methods-In a randomized, multicenter (12 sites) clinical trial, 114 infants with a unilateral congenital cataract were assigned to undergo cataract surgery between 1 to 6 months of age either with or without primary IOL implantation. Contact lenses were used to correct aphakia in patients who did not receive IOLs. Grating visual acuity was tested at 1 year of age by a masked traveling examiner Main Outcome Measures-Grating visual acuity at 1 year of age.Results-The median logMAR visual acuity was not significantly different between the treated eyes in the two groups (CL = 0.80, IOL = 0.97, p =.20). More patients in the IOL group underwent one or more additional intraocular surgeries than patients in the CL group (63% vs 12%; p <. 0001). Most of these additional surgeries were performed to clear lens reproliferation and pupillary membranes from the visual axis.Conclusions-There was no statistically significant difference in grating visual acuity at age 1 year between the IOL and CL groups; however, additional intraocular surgeries were performed more frequently in the IOL group.Application to Clinical Practice-Until longer term follow-up data are available, caution should be exercised when performing IOL implantation in children 6 months of age or younger given the higher incidence of adverse events and the absence of an improved short-term visual outcome compared to contact lens use.