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.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY011751-15
Application #
8013817
Study Section
Special Emphasis Panel (ZEY1-VSN (03))
Program Officer
Everett, Donald F
Project Start
1997-05-01
Project End
2013-12-31
Budget Start
2011-01-01
Budget End
2011-12-31
Support Year
15
Fiscal Year
2011
Total Cost
$6,266,326
Indirect Cost
Name
Jaeb Center for Health Research, Inc.
Department
Type
DUNS #
957043193
City
Tampa
State
FL
Country
United States
Zip Code
33647
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
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 (2016) Clinical factors associated with moderate hyperopia in preschool children with normal stereopsis and visual acuity. J AAPOS 20:455-457
Holmes, Jonathan M; Manh, Vivian M; Lazar, Elizabeth L et al. (2016) Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial. JAMA Ophthalmol 134:1391-1400
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
Mohney, Brian G; Cotter, Susan A; Chandler, Danielle L et al. (2016) Reply. Ophthalmology 123:e22
Pediatric Eye Disease Investigator Group; Mohney, Brian G; Cotter, Susan A et al. (2015) A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age. Ophthalmology 122:1718-25
Leske, David A; Holmes, Jonathan M; Melia, B Michele et al. (2015) Evaluation of the Intermittent Exotropia Questionnaire using Rasch analysis. JAMA Ophthalmol 133:461-5
Pediatric Eye Disease Investigator Group; Wallace, David K; Lazar, Elizabeth L et al. (2015) A randomized trial of adding a plano lens to atropine for amblyopia. J AAPOS 19:42-8

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