CONVERGENCE INSUFFICIENCY TREATMENT TRIAL

Southern California College Of Optometry, Fullerton CA

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): This proposal is for the Southern California College of Optometry (SCCO) to serve as 1 of 9 clinical centers for the Convergence Insufficiency Treatment Trial (CITT). The CITT is a multi-center randomized trial designed to compare the effectiveness of 2 active treatment modalities for patients with convergence insufficiency (CI), a distinct disorder of [unreadable] binocular vision affecting approximately 5% of children and young adults in the United States. The treatments, pencil push-up therapy and vision therapy/orthoptics, are significantly different in cost and number of office visits required, with pencil push-ups being significantly less costly in time and money. [unreadable] In the proposed clinical trial, 392 patients with symptomatic CI between the ages of 9 and 30 years will be randomly assigned to: (1) office-based vision therapy/orthoptics, (2) a control (placebo office-based vision therapy/orthoptics), 3) standard home-based pencil push-up therapy, and 4) office-based pencil push-up therapy. Signs and symptoms of CI will be measured by a masked examiner at baseline and after every 4 weeks of treatment during a 12-week treatment phase. The primary outcome measure is the score from the CITT Symptom Survey at the end of the 12-week treatment phase. Secondary outcome measures are the near point of convergence and positive fusional vergence at near. [unreadable] Successfully treated patients will be followed for an additional 12 months to evaluate the long-term persistence of symptomatic relief and improved clinical findings. This application documents SCCO's ability to serve as a CITT Clinical Center and meet its objectives which include: (1) recruiting and enrolling at least 45 eligible patients within the 24-month recruitment period, (2) recruiting [unreadable] Hispanic/Latino and Asian patients to ensure ethnic/racial diversity, (3) following the CITT recruitment, randomization, examination, treatment, and follow-up protocols for each patient, (4) maintaining patient and examiner masking, and (5) striving for study visits to be completed within the visit windows, with no missed visits and no loss to follow up, and (6) retaining successfully treated patients for an additional 12 month follow-up period. In addition, documentation is contained herein that the SCCO Clinical Center has appropriate personnel, facilities, and equipment to conduct the study in accordance with the CITT Manual of Procedures. Complete details of the rationale, design, and methods are contained in the applications submitted by the Study Chair and Data Coordinating Center and the Manual of Procedures, which have been submitted separately. [unreadable] [unreadable] [unreadable] [unreadable]