Convergence Insufficiency Treatment Trial

收敛不足治疗试验

• 批准号: 6954632
• 负责人: MARJEAN T KULP
• 金额: $ 15.72万
• 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/6954632
• 关键词: clinical research; clinical trials; cooperative study; disease /therapy duration; eye movement disorders; functional ability; human subject; human therapy evaluation; patient oriented research; physical therapy; sign /symptom; statistics /biometry; vision; vision tests

DESCRIPTION (provided by applicant): This proposal is for The Ohio State University College of Optometry (TOSUCO) to serve as one of 9 clinical centers in the Convergence Insufficiency Treatment Trial (CITT). The CITT is a multi-center randomized clinical trial designed to compare the effectiveness of two active treatment approaches for patients with convergence insufficiency (CI). In the proposed randomized clinical trial, 392 CI patients between the ages of 9 and 30 years will be randomly assigned to: 1) office-based vision therapy/orthoptics, 2) placebo office-based vision therapy/orthoptics, 3) standard home-based Pencil Push-ups, or 4) office-based Pencil Push-up therapy. Measurements of the signs and symptoms of CI will be made prior to randomization, and by masked examiners after every 4 weeks of treatment during the 12-week treatment phase. Patients who are successful (based on symptoms) after 12 weeks of treatment will be followed for an additional 12 months (with masked examinations at 6 and 12 months). The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey. Secondary outcome measures include the near point of convergence and positive fusional vergence at near. Our objective at TOSUCO Clinical Center will be to enroll at least 45 patients in the 24-month recruitment period. In this application, we document our ability to recruit at least 45 patients during the 24-month recruitment period, and to retain patients who are successful after 12 weeks of treatment for one year of follow-up 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 centers across the U.S. The Study Chair is located at the Pennsylvania College of Optometry and the national Data Coordinating Center is located at The Ohio State University Optometry Coordinating Center.

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是一项多中心随机临床试验，旨在比较会聚功能不全（CI）患者的两种积极治疗方法的有效性。 在拟议的随机临床试验中，392名年龄在9岁至30岁之间的CI患者将被随机分配到：1）基于办公室的视力治疗/矫正，2）基于办公室的安慰剂视力治疗/矫正，3）标准基于家庭的仰卧起坐俯卧撑，或4）基于办公室的仰卧起坐俯卧撑治疗。 CI的体征和症状将在随机化前进行测量，并在12周治疗期内每4周治疗后由设盲检查者进行测量。成功的患者 治疗12周后，将再随访12个月（在6个月和12个月时进行盲态检查）。主要结果测量是在会聚不足症状调查中的得分。次要结果测量包括近会聚点和近正融合聚散度。我们在TOSUCO临床中心的目标是在24个月的招募期内招募至少45例患者。 在本申请中，我们记录了我们在24个月招募期内招募至少45名患者的能力，并保留治疗12周后成功的患者，在完成治疗后进行一年的随访。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之外，美国还有其他8家验光/眼科诊所中心。 宾夕法尼亚验光学院和国家数据协调中心位于俄亥俄州州立大学验光协调中心。