This application is for a 5-year extension of funding for the Pediatric Eye Disease Investigator Group (PEDIG) Coordinating Center (CC). Since its inception in 1997, PEDIG has conducted 4 protocols in strabismus, 19 protocols in amblyopia, 3 protocols in nasolacrimal duct obstruction, 2 protocols in myopia/hyperopia, &several pilot studies. By the time the funding requested in this application would begin, it is expected that 3 new protocols will have started: a randomized trial to evaluate treatment for convergence insufficiency, a randomized trial to compare botulinum toxin with incisional surgery for esotropia, and a clinical disease registry to evaluate uveitis incidence in children with juvenile idiopathic arthritis. Despite these accomplishments, many important questions and controversies remain in pediatric eye care and strabismus. PEDIG has developed, or will be developing, clinical trials to address many of these questions. These include (1) treatment strategies for children with a visual deficit despite maximal amblyopia treatment, (2) the effect of prescribing versus not prescribing spectacles for hyperopia in young children, (3) the best surgical and non-surgical treatments for intermittent exotropia, (4) risk factors for complications after cataract surgery, ad (5) the optimal treatment for convergence insufficiency.
Specific aims for the next 5-year funding period for PEDIG are to: (1) complete the 7 protocols that are expected to be in progress at the time the funding period begins, (2) initiate 10 new protocols in common pediatric eye disorders where the current management does not have a proven rationale, (3) continue to expand the PEDIG network by soliciting the participation of new sites and encouraging the involvement of young investigators, (4) continue to educate pediatric ophthalmologists, pediatric optometrists, and clinical research coordinators on the principles of clinical trials and good research practices (5) train pediatric ophthalmologists and pediatric optometrists to be leaders in clinical trials an clinical research, and (6) develop new methods and outcome measures needed to conduct future amblyopia and strabismus trials as described in the parallel MCPDOC grant proposal. The Coordinating Center plays a key role in the Network's ability to achieve these goals.

Public Health Relevance

This project will have a significant impact on pediatric eye care and on quality of life of children. Much of pediatric eye care practice is based on clinical impression or limited evidence, and conducting the proposed studies will provide the high-level evidence needed to guide the management of common childhood eye diseases such as amblyopia, strabismus, cataract, intraocular inflammation, and refractive error.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10EY011751-18
Application #
8474230
Study Section
Special Emphasis Panel (ZEY1-VSN (05))
Program Officer
Everett, Donald F
Project Start
1997-05-01
Project End
2018-12-31
Budget Start
2014-01-01
Budget End
2014-12-31
Support Year
18
Fiscal Year
2014
Total Cost
$2,763,504
Indirect Cost
$781,781
Name
Jaeb Center for Health Research, Inc.
Department
Type
DUNS #
957043193
City
Tampa
State
FL
Country
United States
Zip Code
33647
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
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
Lee, Katherine A; Chandler, Danielle L; Repka, Michael X et al. (2013) A comparison of treatment approaches for bilateral congenital nasolacrimal duct obstruction. Am J Ophthalmol 156:1045-50
Weise, Katherine K; Kaminski, Brett; Melia, Michele et al. (2013) Intraobserver reliability of contact pachymetry in children. J AAPOS 17:144-8
Lyon, Don W; Hopkins, Kristine; Chu, Raymond H et al. (2013) Feasibility of a clinical trial of vision therapy for treatment of amblyopia. Optom Vis Sci 90:475-81
Writing Committee for the Pediatric Eye Disease Investigator Group; Cotter, Susan A; Foster, Nicole C et al. (2012) Optical treatment of strabismic and combined strabismic-anisometropic amblyopia. Ophthalmology 119:150-8
Bradfield, Yasmin S; Kaminski, Brett M; Repka, Michael X et al. (2012) Comparison of Tono-Pen and Goldmann applanation tonometers for measurement of intraocular pressure in healthy children. J AAPOS 16:242-8
Holmes, Jonathan M; Lazar, Elizabeth L; Melia, B Michele et al. (2011) Effect of age on response to amblyopia treatment in children. Arch Ophthalmol 129:1451-7
Pediatric Eye Disease Investigator Group (PEDIG) Writing Committee; Wallace, David K; Kraker, Raymond T et al. (2011) Randomized trial to evaluate combined patching and atropine for residual amblyopia. Arch Ophthalmol 129:960-2

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