CONVERGENCE INSUFFICIENCY TREATMENT TRIAL

该NEI计划拨款提案支持多中心临床试验程序的发展和完善，该试验旨在比较目前接受的两种治疗收敛功能不全（CI）患者的治疗方法的收益和成本。CI是一种非常常见和独特的双目视力障碍。它影响了美国大约5%的儿童和成人，它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的临床症状包括近处远处大于近处的外斜视，近会聚点缩小，正性会聚减弱。常见症状包括重影、眼疲劳、头痛和阅读时视力模糊。对于CI最有效的治疗方法尚无共识。最常见的两种治疗方法是“铅笔俯卧撑”和视力治疗/矫正。这两种手术在费用和就诊次数上存在显著差异，铅笔俯卧撑是更便宜的选择。需要一项前瞻性、隐蔽性、对照研究来确定这些被广泛接受的治疗方法的相对收益和成本。在拟议的研究中，会聚功能不全治疗试验（CITT），年龄在9到30岁之间的患者将被随机分配到：1)家庭铅笔俯卧撑治疗，或2)办公室视力治疗。CI的体征和症状将由蒙面检查人员在基线、12周治疗阶段和12个月随访后进行测量。主要结果变量将是根据体征（近收敛点和正融合收敛点）和症状的改善程度，将患者分为“成功”、“改善”或“失败”治疗类别的人数。在进行这项多中心临床试验之前，需要进行大量的前期工作。规划赠款将允许CITT研究小组进行试点研究，以展示招募潜力，评估治疗依从性，确定样本量，完善资格和结果的类别和措施，并制定程序手册。

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.