Convergence Insuffiency Treatment Trial

收敛不足治疗试验

• 批准号: 6954166
• 负责人: MITCHELL M SCHEIMAN
• 金额: $ 67.41万
• 依托单位: SALUS 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/6954166
• 关键词: adolescence (12-20); binocular vision; clinical research; clinical trials; disease /therapy duration; experimental designs; eye disorder diagnosis; health care facility; home health care; human subject; human therapy evaluation; longitudinal human study; medical outreach /case finding; middle childhood (6-11); patient oriented research; pediatrics; sign /symptom; therapy; vision disorders

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.

描述（由申请人提供）：这是研究主席针对收敛不足治疗试验 (CITT) 的资助提案。 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不足 (CI) 儿童的有效性。 CI 是一种普遍且独特的双眼视觉障碍。典型症状包括复视、眼睛疲劳、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 的临床症状包括近处的外隐斜大于远处的外隐斜、近处会聚点后退以及近处的正融合聚散度降低。 关于 CI 最有效的治疗方法尚未达成共识。两种常用的积极治疗方法是铅笔俯卧撑疗法（这是护理标准）和视觉疗法/矫正光学疗法。 这两种治疗方式在费用和所需就诊次数方面存在显着差异，铅笔俯卧撑疗法更便宜，时间也更少。目前还没有精心设计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 岁至 18 岁的患者将被随机分配至：1) 办公室视觉治疗/矫正光学，2) 安慰剂办公室视觉治疗/矫正，3) 标准家庭铅笔俯卧撑治疗，以及 4) 办公室铅笔俯卧撑治疗。在 12 周的治疗阶段，每 4 周治疗一次后，将由蒙面检查员在资格检查时对 CI 的体征和症状进行测量。治疗12周后成功的患者将被随访12个月，以观察长期治疗效果。主要结果指标是收敛不足症状调查的得分。 其他结果指标包括近点收敛和近点正融合收敛。该研究主席拨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结果以及 CITT 程序手册。