This application is for a five-year extension of funding for the Pediatric Eye Disease Investigator Group (PEDIG). PED is supported through a single grant to the PEDIG Coordinating Center (CC), which funds all 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. During its funding period since 1997, the network has conducted or is currently conducting one protocol in congenital esotropia and six protocols in amblyopia. 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 and one new strabismus protocol will have begun. The network has developed a standardized, computerized visual acuity testing protocol for children and a quality of life measurement instrument for treatment of amblyopia, which have been used in the PEDIG protocols and which will be a resource for other investigators. ? ? 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 as described in B2. 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. The structure is not intended to support studies requiring complex procedures requiring extensive site training and/or expensive equipment with limited availability. ? ?

National Institute of Health (NIH)
National Eye Institute (NEI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Application #
Study Section
Special Emphasis Panel (ZEY1-VSN (09))
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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