Convergence Insufficiency Treatment Trial (CITT)

描述(由申请人提供)：本提案是迈阿密大学医学院巴斯科姆帕尔默眼科研究所作为汇聚性功能不全治疗试验(CITT)的临床中心。CITT是一项多中心随机临床试验，旨在比较两种积极治疗方法对收敛功能不全(CI)患者的有效性。在拟议的随机临床试验中，392名年龄在9岁到30岁之间的患者将被随机分配到：1)基于办公室的视力治疗/矫形术，2)安慰剂基于办公室的视力治疗/矫形术，3)标准的家庭铅笔俯卧撑治疗，以及4)基于办公室的铅笔俯卧撑治疗。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。治疗12周后成功的患者将接受12个月的随访。主要的结果衡量标准是融合不足症状调查的得分。次要结果指标将包括NEAR汇聚点和NEAR的正融合收敛。我们在巴斯科姆帕尔默眼科研究所的目标是识别、筛选和评估潜在的研究参与者，并招募符合条件的患者参加融合功能不全治疗试验。本申请证明巴斯科姆·帕尔默眼科研究所有能力在24个月的招募期内招收至少45名患者，并在治疗完成后将每个成功治疗的患者保留一年。还提供了文件，以确认巴斯科姆帕尔默眼科研究所拥有根据CITT程序手册(MOP)进行研究的人员、设备、设施和临床试验经验。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。除了巴斯科姆·帕尔默眼科研究所外，还将有其他8个临床中心担任宾夕法尼亚验光学院和俄亥俄州立大学数据协调中心的研究教席。

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 randomized clinical trial designed to compare the effectiveness of two active treatment approaches for patients with convergence insufficiency (CI). In the proposed randomized clinical trial 392 patients between the ages of 9 and 30 years will be randomly assigned to: 1) office-based vision therapy/orthoptics, 2) placebo office-based vision therapy/orthoptics, 3) standard home-based pencil push-up therapy, and 4) office-based pencil push-up therapy. 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 successful after 12 weeks of treatment will be followed for 12 months. The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey. Secondary outcome 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 enroll at least 45 patients within the 24 month recruitment period, and to retain each successfully treated patient for one year after completion of treatment. Documentation is also provided to confirm 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.