This application is one of paired applications requesting a five-year extension of funding for the Pediatric Eye Disease Investigator Group (PEDIG). This application specifically requests funding of the Network Chair's Office and the Procedures Development and Operation Center. PEDIG would then be supported through two grants, this Chair's grant and a parallel PEDIG Coordinating Center (CC) grant, which funds all other aspects of the group either directly or through subcontracts. PEDIG was formed to conduct clinical research in strabismus, amblyopia, and other eye disorders that affect children. Since the last competitive renewal in 2003, PEDIG has completed 4 randomized clinical trials, 4 prospective observational studies, and 2 pilot studies. As of April 1, 2007, 4 randomized trials and 3 observational studies are active, and all close to completion of enrollment. Six new protocols are nearing the end of development and will be launched prior to the end of the current funding cycle. We plan to complete these 6 protocols and we plan to initiate approximately 10 new protocols in amblyopia, strabismus, and other pediatric eye disorders. The rationale for a network such as PEDIG is that efficiency is enhanced and costs reduced by having a single ongoing infrastructure that is able to conduct multiple concurrent and consecutive studies. The start-up time to implement a new trial from the inception of the concept for the trial to initiation of recruitment is greatly shortened. The primary focus of PEDIG involves studies that can be conducted through simple protocols with limited data collection and implemented by both university-based and community-based pediatric eye care practitioners as part of their routine practice. The investigator group includes both pediatric ophthalmologists and pediatric optometrists in an open network. This structure also provides for the opportunity to prospectively collect data using a standardized protocol outside of randomized trials. This includes common conditions for which natural history data are not available and uncommon conditions and/or treatments for which meaningful data could only be collected by a large number of investigators each contributing a few patients. PEDIG has addressed, and will continue to address, important questions in children's eye care that will continue to improve treatments for childhood eye diseases.
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