CONVERGENCE INSUFFICIENCY TREATMENT TRIAL

收敛不足治疗试验

• 批准号: 6191434
• 负责人: MITCHELL M SCHEIMAN
• 金额: $ 10.78万
• 依托单位: SALUS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2002-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6191434
• 关键词: binocular vision; clinical research; clinical trials; exercise; experimental designs; extraocular muscle; eye coordination disorder; eye movements; eye refraction disorder; health economics; human subject; human therapy evaluation; longitudinal human study; outcomes research; outpatient care; quality of life; therapy compliance; vision disorders; vision tests

This NEI planning grant proposal supports the development and refinement of procedures for a multi-center clinical trial that will be designed to compare the benefits and costs of two currently accepted treatment approaches for patients with convergence insufficiency (CI). CI is a very common and distinct binocular vision disorder. It affects approximately 5 percent of children and adults in the United States, and it 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. Common symptoms include double vision, eyestrain, headaches, and blurred vision while reading. There is no consensus regarding the most effective treatment for CI. The two most common treatments are "pencil push-ups" and vision therapy/orthoptics. Significant differences exist between the two procedures in cost and number of visits required, with pencil push-ups the less expensive alternative. A prospective, masked, controlled study is needed to determine the relative benefits and costs of these widely accepted treatments. In the proposed study, Convergence Insufficiency Treatment Trial (CITT), patients between the ages of 9 and 30 years will be randomly assigned to: 1) home-based pencil push-up treatment, or 2) office-based vision therapy. Measurements of the signs and symptoms of CI will be made by masked examiners at baseline, during the 12-week treatment phase, and after 12-months of follow-up. The primary outcome variable will be the number of patients classified into treatment categories "success," "improvement," or "failure," based on the level of improvement in the signs (near point of convergence and positive fusional vergence) and symptoms. Significant preliminary work needs to be performed before undertaking this multi-center clinical trial. The planning grant award will allow the CITT Study Group to conduct pilot studies to demonstrate recruitment potential, assess adherence with treatments, determine sample size, refine categories and measures for eligibility and outcomes, and develop the manual of procedures.

该NEI计划拨款提案支持多中心临床试验程序的开发和完善，该临床试验旨在比较两种目前接受的会聚功能不全（CI）患者治疗方法的获益和成本。 CI是一种非常常见和独特的双眼视觉障碍。 它影响了美国大约5%的儿童和成年人，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、近会聚点后退和正融合聚散度降低。常见的症状包括复视、眼疲劳、头痛和阅读时视力模糊。关于CI的最有效治疗方法尚未达成共识。 两种最常见的治疗方法是“铅笔俯卧撑”和视力治疗/矫正。 这两种手术在费用和所需就诊次数方面存在显着差异，铅笔俯卧撑是较便宜的选择。 需要一项前瞻性、设盲、对照研究来确定这些广泛接受的治疗的相对效益和成本。在拟议的研究中，会聚不足治疗试验（CITT），年龄在9岁至30岁之间的患者将被随机分配到：1）基于家庭的铅笔俯卧撑治疗，或2）基于办公室的视力治疗。 在基线、12周治疗期间和12个月随访后，将由设盲的检查者测量CI的体征和症状。 主要结局变量将是根据体征（近会聚点和融合性聚散阳性）和症状的改善水平，分为治疗类别“成功”、“改善”或“失败”的患者数量。在开展这项多中心临床试验之前，需要进行大量的前期工作。 计划补助金将允许CITT研究小组进行试点研究，以证明招募潜力，评估治疗依从性，确定样本量，细化类别和资格和结果的衡量标准，并制定程序手册。