This application is for a five-year extension of funding for the Pediatric Eye Disease Investigator Group (PEDIG) for the PEDIG Coordinating Center (CC). In tandem with this application, a separate application is being submitted for the PEDIG Chair's Office. PEDIG was formed to conduct clinical research in strabismus, amblyopia, and other eye disorders that affect children. 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. PEDIG's accomplishments were recognized by the Inventory and Evaluation of Clinical Research Networks (IECRN) as a part of the NIH's roadmap initiative. During its funding period since 1997, the network has conducted or is currently conducting two protocols in esotropia, 12 protocols in amblyopia, two protocols in nasolacrimal duct obstruction, and one protocol in myopia. In addition, several pilot studies have been conducted. By the time the funding specified in this application begins, it is expected that four new amblyopia protocols will have begun as well as a protocol in juvenile idiopathic arthritis and a protocol to determine normal corneal thickness in the pediatric population. Other accomplishments of the network include development of a standardized, computerized visual acuity testing protocol for children, a quality of life measurement instrument for treatment of amblyopia, and a quality of life instrument for nasolacrimal duct obstruction. The specific PEDIG aims for the next funding period include: (1) complete 6 protocols that are expected to be in progress at the time the funding period begins, (2) initiate approximately 10 new protocols in pediatric eye disorders, (3) continue to expand the PEDIG network by soliciting the participation of new investigators and new sites, and (4) continue to educate the pediatric ophthalmology and optometry communities on the principles of clinical trials and train selected pediatric ophthalmologists and optometrists to be leaders in clinical trials. The Coordinating Center plays a key role in the Network's ability to achieve these goals.

National Institute of Health (NIH)
National Eye Institute (NEI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZEY1-VSN (03))
Program Officer
Everett, Donald F
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Jaeb Center for Health Research, Inc.
United States
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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
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 :
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
Pediatric Eye Disease Investigator Group; Christiansen, Stephen P; Chandler, Danielle L et al. (2016) Tonic pupil after botulinum toxin-A injection for treatment of esotropia in children. J AAPOS 20:78-81
Chen, Angela M; Cotter, Susan A (2016) The Amblyopia Treatment Studies: Implications for Clinical Practice. Adv Ophthalmol Optom 1:287-305
Mohney, Brian G; Cotter, Susan A; Chandler, Danielle L et al. (2016) Reply. Ophthalmology 123:e22
Repka, Michael X; Dean, Trevano W; Lazar, Elizabeth L et al. (2016) Cataract Surgery in Children from Birth to Less than 13 Years of Age: Baseline Characteristics of the Cohort. Ophthalmology 123:2462-2473

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