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）：该提案是针对俄亥俄州立大学验光学院（Tosuco）作为收敛性不足治疗试验（CITT）的9个诊所中心之一。 CITT是一项多中心临床试验，旨在将两种常见的收敛性不足（CI）与安慰剂的有效性进行比较。 在拟议的研究中，将249名9至30岁的CI患者随机分配给：1）家庭铅笔俯卧撑疗法，2）基于办公室的视力疗法/正t，或3）基于安慰剂办公室的视力疗法/正t。在12周治疗阶段，在随机分组前和戴掩盖的检查员进行CI的体征和症状的测量。此外，在12周治疗阶段成功治疗（基于症状）的患者将持续12个月（在6个月和12个月时进行掩盖检查）。主要结果变量是 在收敛性功能不全症状调查中得分。次要措施包括近乎收敛的近点和正融合的阳性。我们在这个诊所中心的目标是在18个月内至少将至少30名患者随机分配。 在此应用中，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一年的随访检查。 还规定，托索科（Tosuco）具有人员，经验，设备和设施，可以按照CITT手册（MOP）进行研究。 CITT理由，设计和方法的完整详细信息包含在MOP中，该拖把与研究主席和数据协调中心应用程序分别提交。除Tosuco外，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）。