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 9 clinical centers in the Convergence Insufficiency Treatment Trial (CITT). The CITT is a multi-center randomized clinical trial designed to compare the effectiveness of two active treatment approaches for patients with convergence insufficiency (CI). In the proposed randomized clinical trial, 392 CI patients between the ages of 9 and 30 years will be randomly assigned to: 1) office-based vision therapy/orthoptics, 2) placebo office-based vision therapy/orthoptics, 3) standard home-based Pencil Push-ups, or 4) office-based Pencil Push-up therapy. Measurements of the signs and symptoms of CI will be made prior to randomization, and by masked examiners after every 4 weeks of treatment during the 12-week treatment phase. Patients who are successful (based on symptoms) after 12 weeks of treatment will be followed for an additional 12 months (with masked examinations at 6 and 12 months). The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey. Secondary outcome measures include the near point of convergence and positive fusional vergence at near. Our objective at TOSUCO Clinical Center will be to enroll at least 45 patients in the 24-month recruitment period. In this application, we document our ability to recruit at least 45 patients during the 24-month recruitment period, and to retain patients who are successful after 12 weeks of treatment for one year of follow-up 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 centers across the U.S. The Study Chair is located at the Pennsylvania College of Optometry and the national Data Coordinating Center is located at The Ohio State University Optometry Coordinating Center.