Intraocular lenses (IOLs) are now the accepted treatment following cataract surgery in older children and are being used increasingly in younger children and infants, but little is known about the safety or efficacy of IOLs for a rapidly growin eye. The objective of the Infant Aphakia Treatment Study (IATS) is to compare the relative efficacy and safety of IOL correction versus contact lens correction in infants with a unilateral congenital cataract removed between the ages of 1 to 7 months. We enrolled 114 patients in IATS between December 2004 and January 2009. Phase 1 of the IATS involved following all patients to one year of age so that grating acuity could be assessed with Teller Acuity cards and was completed in January 2010. Phase 2 of IATS involved following all patients to 5 years of age and assessing optotype acuity with the HOTV test at age 4 1/2 years test and was completed in early 2014. We are now requesting additional funding to perform one more clinical examination of these patients at age 10 years so that the incidence of glaucoma after a longer- term follow-up can be compared between the two treatment groups. In addition, we will characterize myopic shift by 10 years in IOL group and identify baseline risk factors such as age of cataract surgery and axial length and other factors that arise during childhood, such as amblyopia and glaucoma, that are associated with a larger than expected myopic shift. The public health importance of this clinical trial not only impacts the approximately 400 children born each year in the United States with a unilateral congenital cataract, but also the 200,000 children worldwide who are blind from cataracts. Phases 1 and 2 of the IATS are funded through two grants, one for the Chairman's Office and one for the Data Coordinating Center (DCC). The purpose of this grant application is to request the additional funding for the DCC for Phase 3. The DCC will carry out the following aspects of IATS: study design, data management, adverse event and patient safety monitoring, statistical reporting and analysis, clinical center monitoring, patient tracking, and trial administration.
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.
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