Convergence Insuffiency Treatment Trial

收敛不足治疗试验

• 批准号: 6869737
• 负责人: MITCHELL M SCHEIMAN
• 金额: $ 64.2万
• 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/6869737
• 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）：这是研究主席对收敛功能不全治疗试验（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功能不全（CI）儿童的有效性。CI是一种常见而独特的双目视力障碍。典型症状包括重影、眼疲劳、头痛和阅读时视力模糊。在美国，它影响了大约5%的儿童，并可能对个人在学校的表现、工作的选择和生活质量产生严重影响。CI的临床征象包括近处远处大于近处的外斜视，近处收敛点缩小，近处正性融合减弱。