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）：本提案旨在让新星东南视光学院 (NSU) 作为融合不足治疗试验 (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不足 (CI) 患者的有效性。 该提案旨在让诺瓦东南视光学院 (NSU) 作为融合不足治疗试验 (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不足 (CI) 患者的有效性。 在拟议的随机临床试验中，392 名年龄在 9 至 30 岁之间的患者将被随机分配至：1) 办公室视觉治疗/矫正，2) 安慰剂办公室视觉治疗/矫正，3) 标准家庭铅笔俯卧撑，4) 办公室铅笔俯卧撑治疗。 CI 体征和症状的测量将在基线时进行，并在 12 周治疗阶段每 4 周治疗后由蒙面检查者进行测量。治疗 12 周后成功的患者将被额外随访 12 个月。主要结果指标是收敛不足症状调查的得分。次要结果指标将包括近点收敛和近点的正融合收敛。我们该临床中心的目标是在 24 个月的招募期内招募至少 45 名患者。 该申请记录了诺瓦东南大学有能力在24个月的招募期内招募至少45名患者，并将经过12周治疗成功的患者保留至治疗完成后一年。还提供的文件表明，诺瓦东南大学视光学院拥有根据 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申请单独提交。除诺瓦东南大学验光学院外，还将设立其他 8 个验光/眼科中心，研究主席设在宾夕法尼亚验光学院，数据协调中心设在俄亥俄州立大学验光协调中心。