Convergence Insufficiency Treatment Trial

收敛不足治疗试验

• 批准号: 7050261
• 负责人: MARJEAN T KULP
• 金额: $ 3.25万
• 依托单位: OHIO STATE 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/7050261
• 关键词: Convergence; Insufficiency; Treatment; Trial

DESCRIPTION (provided by applicant): This proposal is for The Ohio State University College of Optometry (TOSUCO) to serve as one of the 9 clinic 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 to convergence insufficiency (CI) to placebo. In the proposed study, 249 CI patients between the ages of 9 and 30 years are randomly assigned to: 1) home based pencil push-up therapy, 2) office based vision therapy/orthoptics, or 3) placebo office-based vision therapy/orthoptics. Measurements of the signs and symptoms of CI are made before randomization and by masked examiners every 4 weeks during the 12-week treatment phase. In addition, patients who are successfully treated (based on symptoms) after the 12-week treatment phase will be followed for an additional 12 months (with masked examinations at 6 and 12 months). The primary outcome variable is the score on the Convergence Insufficiency Symptom Survey. Secondary measures include the near point of convergence and positive fusional vergence at near. Our objective at this Clinic Center is to randomize at least 30 patients in 18 months. In this application, we document our ability to recruit more than 30 patients within 18 months, and to retain each patient in the study for one year of follow-up examinations after completion of treatment. Documentation is also provided that TOSUCO has the personnel, experience, 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 TOSUCO, there are 8 other optometric/ophthalmologic clinic sites across the U.S., Study Chair (Philadelphia) and the national Coordinating Center (also located at TOSUCO).

描述（由申请人提供）：本提案旨在将俄亥俄州州立大学视光学学院（TOSUCO）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（CI）与安慰剂的有效性。 在拟定的研究中，249名9至30岁的CI患者被随机分配至：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的体征和症状的测量在随机化之前进行，并且在12周的治疗阶段期间由设盲的检查者每4周进行一次。此外，在12周治疗期后成功治疗（基于症状）的患者将额外随访12个月（在6个月和12个月进行设盲检查）。主要结果变量是 聚合不足症状调查的评分。次要措施包括近收敛点和近正融合聚散度。我们在该临床中心的目标是在18个月内随机分配至少30名患者。 在本申请中，我们记录了我们在18个月内招募30多名患者的能力，并在完成治疗后将每位患者保留在研究中进行一年的随访检查。 还应提供文件证明TOSUCO拥有按照CITT程序手册（MOP）开展研究所需的人员、经验、设备和设施。 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TOSUCO，在美国还有8个其他验光/眼科诊所，研究主席（费城）和国家协调中心（也位于TOSUCO）。