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 #
5U10EY018810-04
Application #
8209128
Study Section
Special Emphasis Panel (ZEY1-VSN (03))
Program Officer
Everett, Donald F
Project Start
2009-01-01
Project End
2013-12-31
Budget Start
2012-01-01
Budget End
2012-12-31
Support Year
4
Fiscal Year
2012
Total Cost
$712,770
Indirect Cost
$240,737
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905
Hatt, Sarah R; Leske, David A; CastaƱeda, Yolanda S et al. (2018) Patient-derived questionnaire items for patient-reported outcome measures in pediatric eye conditions. J AAPOS 22:445-448.e22
Liebermann, Laura; Leske, David A; Hatt, Sarah R et al. (2018) Dose Effect and Stability of Postoperative Cyclodeviation After Adjustable Harada-Ito Surgery. Am J Ophthalmol 196:91-95
Pediatric Eye Disease Investigator Group; Writing Committee; Donahue, Sean P et al. (2018) A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia. Ophthalmology :
Shah, Saumya M; Martinez-Thompson, Jennifer M; Diehl, Nancy N et al. (2018) Adult-onset nonparalytic, small-angle hypertropia. J AAPOS 22:438-440
Liebermann, Laura; Leske, David A; Hatt, Sarah R et al. (2018) Test-retest variability of cyclodeviations measured using the double Maddox rod test. J AAPOS 22:146-148.e1
Manh, Vivian M; Holmes, Jonathan M; Lazar, Elizabeth L et al. (2018) A Randomized Trial of a Binocular iPad Game Versus Part-Time Patching in Children Aged 13 to 16 Years With Amblyopia. Am J Ophthalmol 186:104-115
Superstein, Rosanne; Dean, Trevano W; Holmes, Jonathan M et al. (2017) Relationship among clinical factors in childhood intermittent exotropia. J AAPOS 21:268-273
Wallace, David K; Kraker, Raymond T; Freedman, Sharon F et al. (2017) Assessment of Lower Doses of Intravitreous Bevacizumab for Retinopathy of Prematurity: A Phase 1 Dosing Study. JAMA Ophthalmol 135:654-656
Pediatric Eye Disease Investigator Group (2016) Home-Based Therapy for Symptomatic Convergence Insufficiency in Children: A Randomized Clinical Trial. Optom Vis Sci 93:1457-1465
Pediatric Eye Disease Investigator Group; Chen, Angela M; Holmes, Jonathan M et al. (2016) A Randomized Trial Evaluating Short-term Effectiveness of Overminus Lenses in Children 3 to 6 Years of Age with Intermittent Exotropia. Ophthalmology 123:2127-36

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