Convergence Insuffiency Treatment Trial

描述（由申请人提供）：这是研究主席对收敛不足治疗试验（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会聚功能不全（CI）儿童的有效性。CI是一种常见的双眼视觉障碍。典型的症状包括复视、眼疲劳、头痛和阅读时视力模糊。它影响了美国大约5%的儿童，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。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。两种常用的处方活性治疗是标准护理的俯卧撑疗法和视力治疗/矫正。 这两种治疗方式在成本和所需的办公室访问次数方面存在显着差异，其中Pushup疗法更便宜，时间更少。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。需要进行随机临床试验来评估这些治疗方法对CI的有效性。 在CITT中，208名9至18岁的患者将被随机分配到：1）基于办公室的视觉治疗/矫形，2）基于办公室的安慰剂视觉治疗/矫形，3）标准家庭铅笔俯卧撑治疗，和4）基于办公室的铅笔俯卧撑治疗。在12周治疗期内，将在合格性检查时测量CI的体征和症状，并由设盲的检查者在治疗后每4周一次进行测量。治疗12周后成功的患者将被随访12个月，以跟踪长期治疗效果。主要结果测量是在会聚不足症状调查中的得分。 其他结果测量包括近会聚点和近正融合聚散度。本研究主席赠款提案提供了临床试验的基本原理和设计。它包括研究主席办公室的预算，临床中心的修订预算，由NEI临床试验计划拨款资助的试点研究的结果，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.