This is the Chairman's grant proposal for the Convergence insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART), a randomized, placebo controlled, clinical trial designed to test the effects of convergence insufficiency (CI) treatment on measures of reading performance and attention. 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 Chairman's grant proposal provides the significance, innovation, and approach for the clinical trial including the results of preliminary studies, and the budget for th Study Chairman's office and functions. Accompanying documents include the CITT-ART Manuals of Procedures, and grant proposals from the CITT-ART Data Coordinating Center and 9 participating Clinical Centers.
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, and trouble remembering what was read). However, the effect of CI treatment on reading and attention is unknown. Results from the proposed study 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.