Convergence Insufficiency Treatment Trial

描述(由申请人提供)：这项建议是为了让诺瓦东南验光学院(NSU)成为汇聚性功能不全治疗试验(CITT)的9个临床中心之一。CITT是一项多中心临床试验，旨在比较两种常见治疗方法对汇聚功能不全患者的疗效 (公司：在这项拟议的研究中，249名年龄在9岁到30岁之间的患者将被随机分配到1)家庭铅笔俯卧撑治疗，2)办公室视力治疗/矫形术，或3)安慰剂办公室视力治疗/矫形术。在12周的治疗阶段，将在基线上测量CI的体征和症状，并由蒙面检查员每4周进行一次测量。12周后(根据症状)被认为治疗成功的患者将再接受12个月的治疗。主要结果变量将是收敛不足症状调查的得分。次要指标将包括近距离收敛点和近距离正融合收敛。我们的目标是 这个临床中心将在18个月内随机选择至少30名患者。这份申请证明了诺瓦东南大学有能力在 18个月，并在治疗结束后保留治疗12周后成功的患者一年。文件还提供了诺瓦东南大学验光学院根据CITT程序手册(MOP)进行研究的人员、设备和设施。CITT的理论基础、设计和方法的完整细节载于《议定书》，该文件与研究主席和数据协调中心的申请书一起单独提交。除了新东南大学验光学院，还将有其他8个验光/眼科临床中心，其研究教席设在宾夕法尼亚视光学院和俄亥俄州立大学验光数据协调中心的数据协调中心。

DESCRIPTION (provided by applicant): This proposal is for the Nova Southeastern College of Optometry (NSU) 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 effectiveness of two common treatment approaches for patients with convergence insufficiency (CO. 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 will be followed by 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 this Clinical Center will be to randomize at least 30 patients in 18 months. This application documents the ability of Nova Southeastern University to recruit at least 30 patients within 18 months, and to retain patients who are successful after 12 weeks of treatment for one year after completion of treatment. Documentation is also provided that Nova Southeastern University College of Optometry 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 Data Coordinating Center applications. In addition to the Nova Southeastern University College of Optometry, there will be 8 other optometric/ophthalmologic clinical centers with the Study Chair at the Pennsylvania College of Optometry and the Data Coordinating Center at The Ohio State University Optometry Data Coordinating Center.