This proposal is for the establishment of a data coordinating center (DCC) at the Jaeb Center for Health Research for the Early Surgery for Congenital Esotropia Trial (ESCET) as well as for the establishment of the administrative structure for the cooperative Strabismus and Pediatric Ophthalmology Research Group (SPORG) to develop and ultimately conduct a series of additional clinical trials in pediatric ophthalmology and strabismus. The ESCET trial is designed to answer the following primary question: Do infants with congenital esotropia who have surgery at 11-18 weeks of age develop better binocular vision and have better ocular motor stability than infants who have surgery at 28-32 weeks of age? The study is a multicenter, randomized, controlled single-masked clinical trial. It has been designed as a simple trial with about 100 pediatric ophthalmologists as investigators that, other than the timing of surgery being determined through the randomization process, approximates standard clinical practice. There have been only two major NEI-supported multi-center clinical trials in pediatric ophthalmology (Cryotherapy for Retinopathy of Prematurity and the Prism Adaptation Study), and there is a remarkable paucity of prospectively-collected data on strabismus and other ocular conditions occurring in childhood, many of which occur fairly commonly in a pediatric ophthalmologist's practice. For a number of these disorders, for which there is no consensus as to the proper treatment, management issues can be addressed through fairly simple protocols incorporated into standard clinical practice. In conjunction with the establishment of the DCC for the ESCET trial, we are proposing that an investigator group be established to develop and ultimately conduct additional trials in pediatric ophthalmology and adult strabismus. Increased efficiency and considerable cost saving can be achieved by conducting a series of trials concurrently.
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