Convergence Insufficiency Treatment Trial

描述(由申请人提供)：这项建议是俄亥俄州立大学验光学院(TOSUCO)作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，年龄在9岁到30岁之间的392名CI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，或4)基于办公室的铅笔俯卧撑治疗。在随机化之前，将对CI的体征和症状进行测量，并在12周的治疗阶段中，由蒙面检查员在每4周治疗后进行测量。成功的病人 (根据症状)治疗12周后，将再随访12个月(6个月和12个月进行蒙面检查)。主要的结果衡量标准是融合不足症状调查的得分。次要结果指标包括NEAR的汇聚点和NEAR的正融合收敛。我们在TOSUCO临床中心的目标是在24个月的招募期间招募至少45名患者。在这份申请中，我们证明了我们有能力在24个月的招募期间招募至少45名患者，并在治疗完成后保留12周后成功的患者进行一年的随访。文件还规定，TOSUCO拥有根据CITT程序手册(MOP)进行研究的人员、经验、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TOSUCO，美国还有其他8个视光/眼科诊所。研究主席位于 宾夕法尼亚验光学院和国家数据协调中心位于俄亥俄州立大学验光协调中心。

DESCRIPTION (provided by applicant): This proposal is for The Ohio State University College of Optometry (TOSUCO) to serve as one of 9 clinical centers 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 CI 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-ups, or 4) office-based Pencil Push-up therapy. Measurements of the signs and symptoms of CI will be made prior to randomization, and by masked examiners after every 4 weeks of treatment during the 12-week treatment phase. Patients who are successful (based on symptoms) after 12 weeks of treatment will be followed for an additional 12 months (with masked examinations at 6 and 12 months). The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey. Secondary outcome measures include the near point of convergence and positive fusional vergence at near. Our objective at TOSUCO Clinical Center will be to enroll at least 45 patients in the 24-month recruitment period. In this application, we document our ability to recruit at least 45 patients during the 24-month recruitment period, and to retain patients who are successful after 12 weeks of treatment for one year of follow-up after completion of treatment. Documentation is also provided that TOSUCO has the personnel, experience, 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 TOSUCO, there are 8 other optometric/ophthalmologic clinic centers across the U.S. The Study Chair is located at the Pennsylvania College of Optometry and the national Data Coordinating Center is located at The Ohio State University Optometry Coordinating Center.