Convergence Insufficiency Treatment Trial

收敛不足治疗试验

• 批准号: 6728074
• 负责人: MARJEAN T KULP
• 金额: $ 12.6万
• 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/6728074
• 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）：本提案为俄亥俄州立大学视光学院（TOSUCO）作为会聚功能不全治疗试验（CITT）的9个临床中心之一。CITT是一项多中心随机临床试验，旨在比较收敛功能不全（CI）患者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/正视镜，2)安慰剂办公室视力治疗/正视镜，3)标准家庭铅笔俯卧撑，或4)基于办公室的铅笔俯卧撑治疗。CI的体征和症状将在随机化之前进行测量，并在12周治疗阶段的每4周治疗后由蒙面检查人员进行测量。成功的病人