Convergence Insufficiency Treatment Trial

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DESCRIPTION (provided by applicant): This proposal is for The Ohio State University College of Optometry (TOSUCO) to serve as one of the 9 clinic centers in the Convergence Insufficiency Treatment Trial (CITT). The CITT is a multi-center clinical trial designed to compare the effectiveness of two common treatment approaches to convergence insufficiency (CI) to placebo. In the proposed study, 249 CI patients between the ages of 9 and 30 years are randomly assigned to: 1) home based pencil push-up therapy, 2) office based vision therapy/orthoptics, or 3) placebo office-based vision therapy/orthoptics. Measurements of the signs and symptoms of CI are made before randomization and by masked examiners every 4 weeks during the 12-week treatment phase. In addition, patients who are successfully treated (based on symptoms) after the 12-week treatment phase will be followed for an additional 12 months (with masked examinations at 6 and 12 months). The primary outcome variable is the score on the Convergence Insufficiency Symptom Survey. Secondary measures include the near point of convergence and positive fusional vergence at near. Our objective at this Clinic Center is to randomize at least 30 patients in 18 months. In this application, we document our ability to recruit more than 30 patients within 18 months, and to retain each patient in the study for one year of follow-up examinations after completion of treatment. Documentation is also provided that TOSUCO has the personnel, experience, equipment, and facilities to conduct the study in accordance with the CITT Manual of Procedures (MOP). Complete details of the CITT rationale, design, and methods are contained in the MOP, which is submitted separately with the Study Chair and Data Coordinating Center applications. In addition to TOSUCO, there are 8 other optometric/ophthalmologic clinic sites across the U.S., Study Chair (Philadelphia) and the national Coordinating Center (also located at TOSUCO).