Convergence Insufficiency Treatment Trial(CITT)

State College Of Optometry, New York NY

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): This proposal is for SUNY, State College of Optometry (SUNYO) 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 benefits and costs of two commonly used treatment approaches for patients with convergence [unreadable] 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/orthopics. 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, and after 6 and 12-months of followup. The primary outcome variable will be the score on the Convergence Insufficiency Symptom Survey. [unreadable] 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 in 18 months. This application documents the ability of SUNYO to recruit at least 30 within 18 months, and to retain patients who are asymptomatic after 12 weeks of treatment for one year after completion of treatment. Documentation is also provided that SUNYO has the personnel, 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 Coordinating Center applications. In addition to SUNYO, there will be 8 other optometric/ophthalmologic clinical centers with the Study Chair in Philadelphia and the Coordinating Center at The Ohio State University Optometry Coordinating Center [unreadable] [unreadable]