Convergence Insufficiency Treatment Trial

收敛不足治疗试验

• 批准号: 6728074
• 负责人: MARJEAN T KULP
• 金额: $ 12.6万
• 依托单位: OHIO STATE 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/6728074
• 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 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.

描述（由申请人提供）：本提案旨在让俄亥俄州立大学视光学院 (TOSUCO) 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 岁至 30 岁之间的 CI 患者将被随机分配至：1) 办公室视觉治疗/矫正器，2) 安慰剂办公室视觉治疗/矫正器，3) 标准家庭视觉治疗/矫正器。基于办公室的铅笔俯卧撑疗法，或 4) 基于办公室的铅笔俯卧撑疗法。 CI 体征和症状的测量将在随机分组之前进行，并在 12 周治疗阶段期间每 4 周治疗后由蒙面检查员进行测量。成功的患者 （根据症状）治疗 12 周后，将进行另外 12 个月的随访（第 6 个月和第 12 个月进行隐蔽检查）。主要结果指标是收敛不足症状调查的得分。次要结果指标包括近点收敛和近点正融合收敛。我们 TOSUCO 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。 在此申请中，我们记录了我们在 24 个月招募期间招募至少 45 名患者的能力，并保留经过 12 周治疗成功的患者，并在治疗完成后进行一年的随访。还提供文件证明 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 基本原理、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单独提交。除了 TOSUCO 之外，美国还有其他 8 个验光/眼科诊所中心。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。