DESCRIPTION (provided by applicant): Congenital cataracts are one of the leading causes of blindness among children. For children born with a unilateral cataract, early surgical intervention and consistent optical correction and patching therapy are critical to achieve good vision in this eye. Glaucoma continues to be one of the most serious long term complications in eyes undergoing cataract surgery during early infancy. The Infant Aphakia Treatment Study (IATS) was designed to compare the visual acuity of children after unilateral congenital cataract surgery randomized to either intraocular lens (IOL) or contact lens (CL) correction. Enrollment and randomized treatment of the target sample size of 114 patients (IOL, n=57; CL, n=57) began in December 2004 and was completed in January 2009. We found that the optotype acuity was not significantly different between the study eyes in the two treatment groups at age 41/2 years (p=.54). However, at the full clinical assessment performed at age 5 years, we found that significantly more study eyes in the IOL group had had at least 1 adverse event (p=.02) and at least 1 additional intraocular surgery (p<.001). We also noted that the cumulative incidence of a diagnosis of glaucoma was similar in study eyes in both treatment groups at age 5 years (IOL group, 19%; CL group, 16%). However, using the combined diagnosis glaucoma or glaucoma suspect status, there was a trend noted for more study eyes in the CL group to be affected between ages 1 and 5 years compared to the IOL group (IOL group, 28%; CL group, 35%). In this renewal application for years 13-16 of the IATS, we are proposing to examine these children one more time, in their 10th year (Phase 3), to further elucidate the relationship between initial optical correction, an IOL or a CL, and the incidence of glaucoma. In addition, we will better characterize the longer term myopic shift that occurs in the eyes randomized to primary IOL implantation.

PUBLIC HEALTH RELEVANCE: Congenital cataracts are one of the leading causes of blindness among children and glaucoma is one of the most serious adverse events that can develop after cataract surgery during infancy. This study will evaluate whether implantation of an intraocular lens during infantile cataract surgery is associated with a lower long-term incidence of glaucoma than leaving the eye aphakic.