Convergence Insufficiency Treatment Trial

收敛不足治疗试验

• 批准号: 6868392
• 负责人: GLADYS L MITCHELL
• 金额: $ 41.15万
• 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/6868392
• 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（由申请人提供）：这是数据协调中心对会聚不足治疗试验（CITT）的资助提案。数据协调中心将设在俄亥俄州州立大学的验光协调中心（OCC）。 CITT是一项多中心临床试验，旨在比较会聚功能不全（CI）患者的两种积极治疗方法的有效性。CI是一种常见的视觉障碍。 典型的症状包括在阅读或近距离工作时出现复视、眼疲劳、头痛和视力模糊。它影响了美国大约5%的儿童和成人，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。CI的临床体征包括近侧比远侧更大的外隐斜、近侧会聚点后退和近侧正融合聚散度降低。 关于CI的最有效治疗方法尚未达成共识。两种积极的治疗方法是 俯卧撑治疗，这是护理标准，以及视力治疗/矫正。这两种手术在成本和所需的门诊次数方面存在显着差异，其中仰卧起坐疗法是较便宜的选择。目前还没有设计良好的研究来比较这两种治疗方法的有效性。需要一项前瞻性、设盲、安慰剂对照研究来确定这些活性治疗对CI的有效性。 在拟议的临床试验中，208名9至18岁的患者将被随机分配到：1）基于办公室的视力治疗/矫正，2）安慰剂基于办公室的视力治疗/矫正，3）标准基于家庭的仰卧起坐俯卧撑治疗，4）基于办公室的仰卧起坐俯卧撑治疗。CI体征和症状的测量值将在资格检查时由设盲检查员每4周收集一次 在12周的治疗阶段。治疗12周后成功的患者（根据症状评分定义）将再接受12个月的随访。主要结局指标是会聚不足症状调查的评分。次要测量将包括近会聚点和近会聚点处的正融合聚散度。 本申请提供了临床试验设计的依据，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（包括OCC）核心成员进行的试点研究的一些结果。