This proposal is for the Southern California College of Optometry (SCCO) to serve as a clinical center for the Convergence Insufficiency Treatment Trial - Attention &Reading Trial (CITT-ART), a multicenter randomized, placebo controlled, clinical trial designed to evaluate the effects of treatment for symptomatic convergence insufficiency (CI) on reading performance and attention in children. In this trial, 324 children aged 9 to <14 years with symptomatic CI will be randomly assigned to: 1) office-based vergence/accommodative therapy with home-reinforcement or 2) office-based placebo therapy with home reinforcement. After 16 weeks of treatment, examiners masked to treatment group assignment will administer the primary outcome measures for: 1) reading comprehension (Wechsler Individual Achievement test [WIAT-III]) reading comprehension subtest and 2) attention (Strengths &Weaknesses of ADHD Symptoms &Normal Behavior Scale [SWAN]). 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. Other secondary outcome measures include: a test of reading fluency (WIATT III), the SNAP test of attention, the CI Symptom Survey, clinical measures of CI (i.e., near point of convergence and positive fusional vergence at near), and assessments of key reading and cognitive components that impact reading comprehension (pseudo word decoding, word reading, and listening comprehension). Long-term effects on reading achievement and attention will be assessed 1-year post treatment. This application documents our site's ability to recruit at least 36 subjects and to retain them for 1 year after completion of treatment. We document 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 clinical 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 CI is a common childhood vision disorder frequently 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 CI treatment on reading and attention is unknown. Results from the proposed trial will lead to a better understanding of these relationships and have important implications for educators, psychologists, eye professionals, and other health care providers 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 #
1U10EY022595-01A1
Application #
8609332
Study Section
Special Emphasis Panel (ZEY1-VSN (01))
Program Officer
Redford, Maryann
Project Start
2014-05-01
Project End
2019-04-30
Budget Start
2014-05-01
Budget End
2015-04-30
Support Year
1
Fiscal Year
2014
Total Cost
$238,666
Indirect Cost
$89,500
Name
Southern California College of Optometry
Department
Ophthalmology
Type
Schools of Optometry/Ophthalmol
DUNS #
073596710
City
Fullerton
State
CA
Country
United States
Zip Code
92831