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-basedand 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.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY018810-05
Application #
8403608
Study Section
Special Emphasis Panel (ZEY1-VSN (03))
Program Officer
Everett, Donald F
Project Start
2009-01-01
Project End
2014-12-31
Budget Start
2013-01-01
Budget End
2014-12-31
Support Year
5
Fiscal Year
2013
Total Cost
$712,770
Indirect Cost
$331,493
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905
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Martinez-Thompson, Jennifer M; Diehl, Nancy N; Holmes, Jonathan M et al. (2014) Incidence, types, and lifetime risk of adult-onset strabismus. Ophthalmology 121:877-82
Holmes, Jonathan M (2014) Screening, confirming, and treating amblyopia based on binocularity. JAMA Ophthalmol 132:820-2
Repka, Michael X; Kraker, Raymond T; Holmes, Jonathan M et al. (2014) Atropine vs patching for treatment of moderate amblyopia: follow-up at 15 years of age of a randomized clinical trial. JAMA Ophthalmol 132:799-805
Pediatric Eye Disease Investigator Group; Cotter, Susan A; Mohney, Brian G et al. (2014) A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia. Ophthalmology 121:2299-310
Hatt, Sarah R; Leske, David A; Liebermann, Laura et al. (2014) Associations between health-related quality of life and the decision to perform surgery for childhood intermittent exotropia. Ophthalmology 121:883-8
Saunte, Jon Peiter; Holmes, Jonathan M (2014) Sustained improvement of reading symptoms following botulinum toxin A injection for convergence insufficiency. Strabismus 22:95-9
Liebermann, Laura; Hatt, Sarah R; Leske, David A et al. (2014) Improvement in specific function-related quality-of-life concerns after strabismus surgery in nondiplopic adults. J AAPOS 18:105-9
Miller, Aaron M; Chandler, Danielle L; Repka, Michael X et al. (2014) Office probing for treatment of nasolacrimal duct obstruction in infants. J AAPOS 18:26-30
Hatt, Sarah R; Leske, David A; Liebermann, Laura et al. (2014) Depressive symptoms associated with poor health-related quality of life in adults with strabismus. Ophthalmology 121:2070-1

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