Convergence Insufficiency Treatment Trial (CITT)

收敛不足治疗试验 (CITT)

• 批准号: 7050269
• 负责人: SUSANNA M TAMKINS
• 金额: $ 3.64万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 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/7050269
• 关键词: Convergence; Insufficiency; Treatment; Trial; CITT

DESCRIPTION (provided by applicant): This proposal is for the Bascom Palmer Eye Institute of the University of Miami, School of Medicine to serve as a clinical center 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 for patients with convergence insufficiency (CI). In the proposed study, 249 patients between the ages of 9 and 30 years will be randomly assigned to: 1) home-based pencil push-up treatment, 2) office-based vision therapy/orthoptics, or 3) placebo office-based vision therapy/orthoptics. Measurements of the signs and symptoms of CI will be made at baseline, and by masked examiners every 4 weeks during the 12-week treatment phase. Patients who are considered successfully treated (based on symptoms) at 12 weeks wilt be followed for an additional 12 months. The primary outcome variable will be the score on the Convergence Insufficiency Symptom Survey. Secondary measures will include the near point of convergence and positive fusional vergence at near. Our objective at the Bascom Palmer Eye Institute is to identify, screen and evaluate potential study participants and to enroll eligible patients in the Convergence Insufficiency Treatment Trial. This application documents the ability of Bascom Palmer Eye Institute to recruit at least 30 patients within 18 months, and to retain each successfully treated patient for one year after completion of treatment. Documentation included confirms the applicant site, the Bascom Palmer Eye Institute, has the personnel, equipment, facilities and clinical trials experience 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 the Bascom Palmer Eye Institute, there will be 8 other clinical centers with the Study Chair at the Pennsylvania College of Optometry and the Data Coordinating Center at The Ohio State University.

描述(由申请人提供)：本提案是迈阿密大学医学院巴斯科姆帕尔默眼科研究所作为汇聚性功能不全治疗试验(CITT)的临床中心。CITT是一项多中心临床试验，旨在比较两种常见治疗方法对趋同患者的疗效 功能不全(CI)。在这项拟议的研究中，249名年龄在9岁到30岁之间的患者将被随机分配到：1)家庭铅笔俯卧撑治疗，2)办公室视力治疗/矫形术，或3)安慰剂办公室视力治疗/矫形术。在12周的治疗阶段，将在基线上测量CI的体征和症状，并由蒙面检查员每4周进行一次测量。12周后被认为治疗成功(根据症状)的患者将再接受12个月的随访。主要结果变量将是收敛不足症状调查的得分。次要措施将包括接近汇聚点和 在NEAR有正的融合收敛。 我们在巴斯科姆帕尔默眼科研究所的目标是识别、筛选和评估潜在的研究参与者，并招募符合条件的患者参加融合功能不全治疗试验。这份申请证明了巴斯科姆·帕尔默眼科研究所有能力在18个月内招募至少30名患者，并在治疗完成后将每个成功治疗的患者保留一年。随附的文件确认了申请地点--Bascom 帕尔默眼科研究所拥有根据CITT程序手册(MOP)进行这项研究的人员、设备、设施和临床试验经验。CITT的理论基础、设计和方法的完整细节载于《议定书》，该文件与研究主席和数据协调中心的申请书一起单独提交。除了巴斯科姆·帕尔默眼科研究所外，还将有其他8个临床中心设有研究主席 在宾夕法尼亚验光学院和俄亥俄州立大学的数据协调中心。