Convergence Insufficiency Treatment Trial

收敛不足治疗试验

• 批准号: 7050267
• 负责人: RACHEL Anastasia COULTER
• 金额: $ 3.11万
• 依托单位: NOVA SOUTHEASTERN 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/7050267
• 关键词: Convergence; Insufficiency; Treatment; Trial

DESCRIPTION (provided by applicant): This proposal is for the Nova Southeastern College of Optometry (NSU) to serve as one of 9 clinical centers in the Convergence Insufficiency Treatment Trial (CITT). The CITT is a multi-center clinical trial designed to compare the effectiveness of two common treatment approaches for patients with convergence insufficiency (CO. In the proposed study, 249 patients between the ages of 9 and 30 years will be randomly assigned to 1) home-based pencil push-up treatment, 2) office-based vision therapy/orthoptics, or 3) placebo office-based vision therapy/orthoptics. Measurements of the signs and symptoms of CI will be made at baseline, and by masked examiners every 4 weeks during the 12-week treatment phase. Patients who are considered successfully treated (based on symptoms) at 12 weeks will be followed by an additional 12 months. The primary outcome variable will be the score on the Convergence Insufficiency Symptom Survey. Secondary measures will include the near point of convergence and positive fusional vergence at near. Our objective at this Clinical Center will be to randomize at least 30 patients in 18 months. This application documents the ability of Nova Southeastern University to recruit at least 30 patients within 18 months, and to retain patients who are successful after 12 weeks of treatment for one year after completion of treatment. Documentation is also provided that Nova Southeastern University College of Optometry has the personnel, equipment, and facilities to conduct the study in accordance with the CITT Manual of Procedures (MOP). Complete details of the CITT rationale, design, and methods are contained in the MOP, which is submitted separately with the Study Chair and Data Coordinating Center applications. In addition to the Nova Southeastern University College of Optometry, there will be 8 other optometric/ophthalmologic clinical centers with the Study Chair at the Pennsylvania College of Optometry and the Data Coordinating Center at The Ohio State University Optometry Data Coordinating Center.

描述（由申请人提供）：本提案旨在将Nova Southeastern College of Optometry（NSU）作为会聚不足治疗试验（CITT）的9个临床中心之一。CITT是一项多中心临床试验，旨在比较两种常见治疗方法对会聚功能不全患者的有效性 (CO.在拟定的研究中，249例年龄在9 - 30岁之间的患者将被随机分配至1）基于家庭的铅笔俯卧撑治疗，2）基于办公室的视力治疗/矫正，或3）安慰剂基于办公室的视力治疗/矫正。CI体征和症状的测量将在基线时进行，并在12周治疗期间由设盲的检查者每4周一次进行。在第12周时被认为成功治疗（基于症状）的患者将再随访12个月。主要结局变量将是会聚功能不全症状调查的评分。次要措施将包括近收敛点和近正融合聚散度。我们的目标是 该临床中心将在18个月内随机分配至少30名患者。 本申请文件证明了诺瓦东南大学招募至少30名患者的能力， 18个月，并保留12周治疗后成功的患者，在完成治疗后一年。还提供了证明Nova Southeastern University College of Optography拥有按照CITT程序手册（MOP）进行研究的人员、设备和设施的文件。 CITT原理、设计和方法的完整详细信息包含在MOP中，该MOP与研究主席和数据协调中心申请一起单独提交。除了Nova Southeastern University College of Optometry，还将有8个其他验光/眼科临床中心，其中宾夕法尼亚验光学院的研究主席和俄亥俄州州立大学验光数据协调中心的数据协调中心。