Convergence Insufficiency Treatment Trial

收敛不足治疗试验

• 批准号: 7117228
• 负责人: GLADYS L MITCHELL
• 金额: $ 35.32万
• 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/7117228
• 关键词: adolescence (12-20); binocular vision; clinical research; clinical trials; data management; disease /therapy duration; eye disorder diagnosis; health care facility; home health care; human subject; human therapy evaluation; longitudinal human study; middle childhood (6-11); patient oriented research; pediatrics; sign /symptom; therapy; vision disorders

DESCRIPTION (provided by applicant): This is the data coordinating center's grant proposal for the Convergence Insufficiency Treatment Trial (CITT). The data coordinating center will be housed in the Optometry Coordinating Center (OCC) at The Ohio State University. The CITT is a multi-center clinical trial designed to compare the effectiveness of two active treatment approaches for patients with convergence insufficiency (CI). CI is a prevalent and distinct vision disorder. Typical symptoms include double vision, eyestrain, headaches, and blurred vision while reading or doing near work. It affects approximately 5% of children and adults in the United States and may have a serious impact on an individual's performance in school or work, choice of jobs, and quality of life. Clinical signs of CI include exophoria that is greater at near than at far, a receded near point of convergence, and reduced positive fusional vergence at near. There is no consensus regarding the most effective treatment for CI. Two active treatments are Pencil Push-up therapy, which is the standard of care, and vision therapy/orthoptics. Significant differences exist between the two procedures in cost and number of office visits required, with Pencil Push-up therapy the less expensive alternative. There have been no well-designed studies that compare the effectiveness of these two treatments. A prospective, masked, placebo-controlled study is needed to determine the effectiveness of these active treatments for CI. In the proposed clinical trial, 208 patients between the ages of 9 and 18 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 collected at the eligibility examination and by masked examiners every 4 weeks during the 12 week treatment phase. Patients who are successful after 12 weeks of treatment (as defined by symptom score) will be followed for 12 additional months. The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey. Secondary measures will include the near point of convergence and postive fusional vergence at near. This application provides the rationale for the design of the clinical trial and a description of the goals and responsibilities of the data coordinating center. This proposal also includes some results from pilot studies performed by the core members of the CITT planning committee including the OCC.

描述(申请人提供)：这是数据协调中心对汇聚性功能不全治疗试验(CITT)的拨款提案。数据协调中心将设在俄亥俄州立大学的验光协调中心(OCC)。CITT是一项多中心临床试验，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。CI是一种普遍存在的明显的视力障碍。 典型的症状包括复视、眼睛疲劳、头痛和在阅读或在附近工作时视力模糊。它影响了大约5%的美国儿童和成年人，并可能对个人在学校或工作中的表现、工作选择和生活质量产生严重影响。脑梗塞的临床症状包括外隐斜度近大于远，近会聚点后退，近距离正融合收敛减弱。 对于脑梗塞最有效的治疗方法，目前还没有达成共识。两种有效的治疗方法是铅笔 俯卧撑疗法，这是护理的标准，以及视力疗法/矫形术。这两种手术在费用和所需就诊次数上存在显著差异，铅笔俯卧撑疗法是成本较低的替代疗法。目前还没有精心设计的研究来比较这两种疗法的有效性。需要一项前瞻性、隐蔽性、安慰剂对照研究来确定这些积极治疗脑梗塞的有效性。在拟议的临床试验中，208名年龄在9岁到18岁之间的患者将被随机分配到：1)基于办公室的视力疗法/矫形术，2)安慰剂基于办公室的视力疗法/矫形术，3)标准的家庭铅笔俯卧撑疗法，以及4)基于办公室的铅笔俯卧撑疗法。CI的体征和症状的测量将在资格考试中进行，并由蒙面检验员每4周收集一次 在12周的治疗阶段。治疗12周后成功的患者(根据症状评分)将再随访12个月。主要的结果衡量标准是融合不足症状调查的得分。次要度量将包括近处的汇聚点和近处的正融合收敛。 本申请为临床试验的设计提供了理论基础，并描述了数据协调中心的目标和职责。该提案还包括CITT规划委员会核心成员(包括OCC)进行的试点研究的一些结果。