Convergence Insufficiency Treatment Trial

收敛不足治疗试验

• 批准号: 6954634
• 负责人: RACHEL Anastasia COULTER
• 金额: $ 15.88万
• 依托单位: NOVA SOUTHEASTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6954634
• 关键词: clinical research; clinical trials; cooperative study; disease /therapy duration; eye movement disorders; functional ability; human subject; human therapy evaluation; patient oriented research; physical therapy; sign /symptom; statistics /biometry; vision; vision tests

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 (CI). 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 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-ups, 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 after every 4 weeks of treatment during the 12-week treatment phase. Patients who are successful after 12 weeks of treatment will be followed for an additional 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 this Clinical Center will be to enroll at least 45 patients in the 24-month recruitment period. This application documents the ability of Nova Southeastern University 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 after completion of treatment. Documentation is also provided that the 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 centers with the Study Chair at the Pennsylvania College of Optometry and the Data Coordinating Center at the Ohio State University Optometry Coordinating Center.

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收敛功能不全(CI)患者的有效性。这项提议是为了让诺瓦东南验光学院(NSU)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，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，以及4)基于办公室的铅笔俯卧撑治疗。在12周的治疗阶段，CI的体征和症状将在基线上进行测量，并在每4周治疗后由蒙面检查员进行测量。治疗12周后成功的患者将再接受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。我们在这个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。 本申请证明诺瓦东南大学有能力在24个月的招聘期内招收至少45名患者，并在治疗结束后12周后留住成功的患者一年。还提供了文件，表明新东南大学验光学院拥有根据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。除了诺瓦东南大学验光学院外，还将有其他8个验光/眼科中心，其研究教席设在宾夕法尼亚大学验光学院和俄亥俄州立大学验光协调中心的数据协调中心。