Convergence Insufficiency Treatment Trial (CITT)

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DESCRIPTION (provided by applicant): This proposal is for the Bascom Palmer Eye Institute of the University of Miami, School of Medicine to serve as a clinical center 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 for patients with convergence insufficiency (CI). In the proposed study, 249 patients between the ages of 9 and 30 years will be randomly assigned to: 1) home-based pencil push-up treatment, 2) office-based vision therapy/orthoptics, or 3) placebo office-based vision therapy/orthoptics. Measurements of the signs and symptoms of CI will be made at baseline, and by masked examiners every 4 weeks during the 12-week treatment phase. Patients who are considered successfully treated (based on symptoms) at 12 weeks wilt be followed for an additional 12 months. The primary outcome variable will be the score on the Convergence Insufficiency Symptom Survey. Secondary measures will include the near point of convergence and positive fusional vergence at near. Our objective at the Bascom Palmer Eye Institute is to identify, screen and evaluate potential study participants and to enroll eligible patients in the Convergence Insufficiency Treatment Trial. This application documents the ability of Bascom Palmer Eye Institute to recruit at least 30 patients within 18 months, and to retain each successfully treated patient for one year after completion of treatment. Documentation included confirms the applicant site, the Bascom Palmer Eye Institute, has the personnel, equipment, facilities and clinical trials experience 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 the Bascom Palmer Eye Institute, there will be 8 other clinical centers with the Study Chair at the Pennsylvania College of Optometry and the Data Coordinating Center at The Ohio State University.