This proposal is for the Pennsylvania College of Optometry at Salus University to serve as a clinical center for the Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART), a multicenter, randomized, placebo controlled, clinical trial designed to evaluate the effects of treatment for symptomatic convergence insufficiency (Cl) on measures of reading performance and attention in children. In this trial, 324 children aged 9 to <14 years with symptomatic Cl will be randomly assigned to 16 weeks of: 1) office-based vergence/ accommodative therapy with home-reinforcement or 2) office-based placebo therapy. After 16 weeks of treatment, the primary outcome measures of reading comprehension (Wechsler Individual Achievement test [WIAT-III] reading comprehension subtest score) and attention (Strengths and Weaknesses of ADHD Symptoms & Normal Behavior Scale [SWAN]) will be assessed by examiners masked to treatment group. The Gates MacGinitie-4 test, which uses a format similar to curriculum-based evaluation done in classrooms, will provide a secondary measure of reading comprehension. Reading fluency, another test of attention, the Cl Symptom Survey, and clinical measures of Cl (i.e., the near point of convergence, and positive fusional vergence at near) are other secondary outcome measures; also included are assessments of key reading and cognitive components that impact reading comprehension including pseudoword decoding, word reading, and listening comprehension. Long-term effects on reading achievement and attention are assessed 1-year post treatment. This application documents our site's ability to recruit at least 36 subjects and o retain them for 1 year after completion of treatment. Documentation is provided that our site has the appropriate personnel, equipment, and facilities to conduct the study in accordance with the CITT-ART Manual of Procedures (MOP). Complete details of the study rationale, design, and methods are contained in the Manual of Procedures (submitted with the Study Chair and Data Coordinating Center [DCC] applications). In addition to our center, there are 8 other optometric or ophthalmologic centers, the Study Chair at the Pennsylvania College of Optometry at Salus University, and the DCC at The Ohio State University Optometry Coordinating Center. Symptomatic Cl is a common vision disorder in children that is commonly associated with symptoms while reading (e.g. loss of place, loss of concentration, frequent re-reading, reading slowly, trouble remembering what was read). However, the effect of Cl treatment on reading and attention is unknown. The results of the proposed study will lead to a better understanding of these relationships and have important implications for educators, psychologists, and physicians who care for children with reading and attention problems. The findings will guide hypothesis development for future scientific investigations in children with vision disorders.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY022587-02
Application #
8838806
Study Section
Special Emphasis Panel (ZEY1-VSN (01))
Program Officer
Redford, Maryann
Project Start
2014-05-01
Project End
2019-04-30
Budget Start
2015-05-01
Budget End
2016-04-30
Support Year
2
Fiscal Year
2015
Total Cost
$176,193
Indirect Cost
$54,233
Name
Salus University
Department
Pediatrics
Type
Schools of Optometry/Ophthalmol
DUNS #
077069904
City
Elkins Park
State
PA
Country
United States
Zip Code
19027