Convergence Insufficiency Treatment Trial (CITT)

University Of Alabama At Birmingham, Birmingham AL

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Abstract

[unreadable] DESCRIPTION (provided by applicant): This proposal is for University of Alabama at Birmingham School of Optometry (UABSO) to serve as one of 9 clinical centers in the Convergence Insufficiency Treatment Trial (CITT). The CITT is a multi-center clinical trial designed to compare the efficacy of two commonly used treatment approaches for patients with [unreadable] convergence insufficiency (Cl). 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) office-based placebo Vision Therapy/Orthoptics. Measurements of the signs and symptoms of CI will be made at baseline, and by masked examiners even/4 weeks during the 12-week treatment phase, and after 6 and 12-months of follow-up. 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 this Clinical Center will be to randomize at least 30 patients over an eighteen month period of time. This application documents the ability of UABSO to recruit at least 30 patients within 18 months, and to retain each patient for one year after completion of treatment. Documentation is also provided that UABSO has the personnel, equipment, and facilities to conduct the study in accordance with the C6TT Manual of [unreadable] 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 Coordinating Center applications, in addition to UABSO, there will be 8 other optometric/ophthalmological clinical centers with the Study Chair in Philadelphia and the Coordinating Center at The Ohio State University Optometry Coordinating Center. [unreadable] [unreadable]