Convergence Insufficiency Treatment Trial (CITT)

描述（由申请人提供）：本提案是为迈阿密大学医学院巴斯科姆帕尔默眼科研究所作为会聚功能不全治疗试验（CITT）的临床中心。CITT是一项多中心随机临床试验，旨在比较收敛功能不全（CI）患者两种积极治疗方法的有效性。在拟议的随机临床试验中，392名年龄在9岁至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/正视镜，2)安慰剂办公室视力治疗/正视镜，3)标准家庭铅笔俯卧撑治疗，4)办公室铅笔俯卧撑治疗。CI的体征和症状将在基线时进行测量，并在12周的治疗阶段每4周由蒙面检查人员进行测量。12周治疗成功的患者将被随访12个月。主要结局指标是收敛不足症状调查得分。次要结果测量将包括近收敛点和正融合收敛点。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会聚功能不全治疗试验。该申请证明了巴斯科姆帕尔默眼科研究所在24个月的招募期内招募至少45名患者的能力，并在治疗完成后将每名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有人员、设备、设施和临床试验经验，可以按照CITT程序手册（MOP）进行研究。CITT基本原理、设计和方法的完整细节包含在MOP中，该MOP与研究主席和数据协调中心的申请一起单独提交。除了巴斯科姆·帕尔默眼科研究所外，宾夕法尼亚大学视光学院和俄亥俄州立大学数据协调中心的研究主席还将成立其他8个临床中心。

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.