This is the data coordinating center's grant proposal for the Convergence Insufficiency Treatment Trial- Attention and Reading Trial (CITT-ART). The Data Coordinating Center (DCC) will be housed in the College of Optometry at The Ohio State University. The CITT-ART is a multi-center randomized clinical trial designed to evaluate the effects of treatment for symptomatic convergence insufficiency (Cl) on reading performance and attention in children. In this trial, 324 children aged 9 to <14 years with symptomatic convergence insufficiency 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 provides the rationale for the design of the clinical trial ad a description of the goals and responsibilities of the DCC. This proposal also includes some results from previous studies performed by the core members of the CITT planning committee including personnel from the DCC. Symptomatic CI 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, and trouble remembering what was read). However, the effect of CI 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.
|CITT-ART Investigator Group; Scheiman, Mitchell; Mitchell, G Lynn et al. (2015) Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART): Design and Methods. Vis Dev Rehabil 1:214-228|