Convergence Insufficiency Treatment Trial (CITT)

描述（由申请人提供）：本提案旨在将迈阿密大学医学院的巴斯科姆帕尔默眼科研究所作为会聚不足治疗试验（CITT）的临床中心。CITT是一项多中心随机临床试验，旨在比较会聚功能不全（CI）患者的两种积极治疗方法的有效性。 在拟定的随机临床试验中，392例年龄在9 - 30岁之间的患者将被随机分配至：1）基于办公室的视力治疗/矫正，2）基于办公室的安慰剂视力治疗/矫正，3）标准基于家庭的铅笔俯卧撑治疗，和4）基于办公室的铅笔俯卧撑治疗。CI体征和症状的测量将在基线时进行，并在12周治疗期间由设盲的检查者每4周一次进行。治疗12周后成功的患者将接受12个月的随访。主要结果测量是在会聚不足症状调查中的得分。次要结局指标将包括近点会聚和近点正融合聚散度。 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，并招募合格的患者参加会聚不足治疗试验。本申请记录了巴斯科姆帕尔默眼科研究所在24个月招募期内招募至少45例患者，并在治疗完成后保留每例成功治疗的患者一年的能力。还提供了文件，以确认巴斯科姆帕尔默眼科研究所拥有按照CITT程序手册（MOP）开展研究的人员、设备、设施和临床试验经验。CITT原理、设计和方法的完整详细信息包含在MOP中，该MOP与研究主席和数据协调中心申请一起单独提交。除了巴斯科姆帕尔默眼科研究所外，还将有8个其他临床中心，其中包括宾夕法尼亚验光学院的研究主席和俄亥俄州州立大学的数据协调中心。

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.