Convergence Insuffiency Treatment Trial

描述(由申请人提供)：这是研究主席对汇聚性功能不全治疗试验(CITT)的拨款建议。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症状性收敛功能不全(CI)儿童的疗效。CI是一种常见且明显的双眼视觉障碍。典型的症状包括复视、眼睛疲劳、头痛和阅读时视力模糊。它影响了大约5%的美国儿童，并可能对个人在学校的表现、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。两种常用的主动疗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。这两种治疗方式在费用和所需就诊次数方面存在显著差异，铅笔推送疗法成本较低，时间密集度较低。目前还没有精心设计的研究来比较这两种疗法的有效性。需要一项随机临床试验来评估这些治疗脑梗塞的疗效。 在CITT中，208名年龄在9至18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治疗，以及4)办公室铅笔俯卧撑治疗。CI的体征和症状将在资格审查时进行测量，并由蒙面检查员在12周的治疗阶段中每4周治疗一次后进行测量。治疗12周后成功的患者将被随访12个月，以跟踪观察长期治疗效果。主要的结果衡量标准是融合不足症状调查的得分。 其他结果指标包括NEAR汇聚点和NEAR的正融合收敛。这项研究主席拨款提案为临床试验提供了理论基础和设计。它包括研究主席办公室的预算、临床中心的修订预算、由NEI临床试验计划补助金资助的先导研究的结果，以及CITT程序手册。

DESCRIPTION (provided by applicant): This is the Study Chair's grant proposal for 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 children with symptomatic convergence insufficiency (CI). CI is a prevalent and distinct binocular vision disorder. Typical symptoms include double vision, eyestrain, headaches, and blurred vision while reading. It affects approximately 5% of children in the United States, and may have a serious impact on an individual's performance in school, 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 commonly prescribed active treatments are Pencil Push-up therapy, which is the standard of care, and Vision Therapy/Orthoptics. Significant differences exist between these two treatment modalities in cost and number of office visits required, with Pencil Pushup therapy being less expensive and less time intensive. There have been no well-designed studies that compare the effectiveness of these two treatments. A randomized clinical trial is needed to evaluate the effectiveness of these treatments for CI. In the CITT, 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 made at the eligibility examination and by masked examiners following every 4 weeks of treatment during the 12-week treatment phase. Patients who are successful after 12 weeks of treatment will be followed for 12 months to follow the long-term treatment effects. The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey. Additional outcome measures include the near point of convergence and positive fusional vergence at near. This Study Chair grant proposal provides the rationale and design for the clinical trial. It includes the budget for the Study Chair's office, revised budgets for the clinical centers, the results of pilot studies funded by an NEI Clinical Trial Planning Grant, and the CITT Manual of Procedures.