Infant Aphakia Treatment Study

The Infant Aphakia Treatment Study (IATS) is a multicenter randomized clinical trial comparing IOL and CL correction for monocular aphakia. Infants will be eligible for the study who are less than 7 months of age and have a visually significant cataract in one eye. Cataract surgery will be performed in a standardized fashion by a surgeon who has been certified for the study. All patients will undergo a lensecto-my, posterior capsulotomy, and anterior vitrectomy. Infants will be randomized at the time of surgery to either IOL implantation or CL correction. Infants randomized to the IOL group will have an IOL implanted into the capsular bag. Spectacles will be used to correct the residual refractive error. Infants randomized to the CL group will be fit with a CL immediately after surgery. All children will be examined by investigators at fixed intervals using standard protocols with the primary outcome being resolution acuity using Teller acuity card, assessed at 12 months of age by a traveling tester. It is anticipated that a second primary outcome examination will be performed on these children when they are 4years of age using optotype visual acuity. Secondary outcomes will include the number of complications requiring reopera-tions, the incidence of cosmetically significant strabismus, the magnitude of the myopic shift, and the stress experienced by the parents of these children.

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