This proposal is for the establishment of a data coordinating center (DCC) at the Jaeb Center for Health Research for the Early Surgery for Congenital Esotropia Trial (ESCET) as well as for the establishment of the administrative structure for the cooperative Strabismus and Pediatric Ophthalmology Research Group (SPORG) to develop and ultimately conduct a series of additional clinical trials in pediatric ophthalmology and strabismus. The ESCET trial is designed to answer the following primary question: Do infants with congenital esotropia who have surgery at 11-18 weeks of age develop better binocular vision and have better ocular motor stability than infants who have surgery at 28-32 weeks of age? The study is a multicenter, randomized, controlled single-masked clinical trial. It has been designed as a simple trial with about 100 pediatric ophthalmologists as investigators that, other than the timing of surgery being determined through the randomization process, approximates standard clinical practice. There have been only two major NEI-supported multi-center clinical trials in pediatric ophthalmology (Cryotherapy for Retinopathy of Prematurity and the Prism Adaptation Study), and there is a remarkable paucity of prospectively-collected data on strabismus and other ocular conditions occurring in childhood, many of which occur fairly commonly in a pediatric ophthalmologist's practice. For a number of these disorders, for which there is no consensus as to the proper treatment, management issues can be addressed through fairly simple protocols incorporated into standard clinical practice. In conjunction with the establishment of the DCC for the ESCET trial, we are proposing that an investigator group be established to develop and ultimately conduct additional trials in pediatric ophthalmology and adult strabismus. Increased efficiency and considerable cost saving can be achieved by conducting a series of trials concurrently.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10EY011751-01
Application #
2020258
Study Section
Special Emphasis Panel (ZEY1-VSN (01))
Project Start
1997-05-01
Project End
2002-04-30
Budget Start
1997-05-01
Budget End
1998-04-30
Support Year
1
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Jaeb Center for Health Research, Inc.
Department
Type
DUNS #
957043193
City
Tampa
State
FL
Country
United States
Zip Code
33647
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
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 (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

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