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）：本提案旨在让俄亥俄州立大学视光学院 (TOSUCO) 作为融合不足治疗试验 (CITT) 的 9 个临床中心之一。 CITT 是一项多中心临床试验，旨在比较两种常见的收敛不足 (CI) 治疗方法与安慰剂的有效性。 在拟议的研究中，249 名年龄在 9 岁至 30 岁之间的 CI 患者被随机分配至：1) 家庭铅笔俯卧撑治疗，2) 办公室视觉治疗/矫正，或 3) 安慰剂办公室视觉治疗/矫正。 CI 体征和症状的测量是在随机分组前进行的，在 12 周的治疗阶段，由蒙面检查者每 4 周进行一次。此外，在 12 周治疗阶段后成功治疗（根据症状）的患者将被额外随访 12 个月（在第 6 个月和第 12 个月进行隐蔽检查）。主要结果变量是 收敛不足症状调查的得分。次要测量包括近点会聚和近处的正融合聚散度。我们该临床中心的目标是在 18 个月内对至少 30 名患者进行随机分组。 在此申请中，我们记录了我们在 18 个月内招募超过 30 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。 还提供文件证明 TOSUCO 拥有根据 CITT 程序手册 (MOP) 进行研究的人员、经验、设备和设施。 CITT 基本原理、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。除托苏科外，美国还有其他 8 个验光/眼科诊所、研究主席（费城）和国家协调中心（也位于托苏科）。