Convergence Insufficiency Treatment Trial

描述（由申请人提供）：本提案旨在将Nova Southeastern College of Optometry（NSU）作为会聚不足治疗试验（CITT）的9个临床中心之一。CITT是一项多中心临床试验，旨在比较会聚功能不全（CI）患者的两种常见治疗方法的有效性。 该提案旨在将Nova Southeastern College of Optometry（NSU）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，4）基于办公室的仰卧起坐俯卧撑治疗。 CI体征和症状的测量将在基线时进行，并在12周治疗期内每4周治疗后由设盲的检查者进行。治疗12周后成功的患者将接受额外12个月的随访。主要结果测量是在会聚不足症状调查中的得分。次要结局指标将包括近点会聚和近点正融合聚散度。我们在该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。 该申请记录了Nova Southeastern University在24个月的招募期内招募至少45名患者的能力，并在完成治疗后保留12周治疗成功的患者一年。还提供了证明Nova Southeastern University College of Optometry拥有按照CITT程序手册（MOP）进行研究的人员、设备和设施的文件。 CITT原理、设计和方法的完整详细信息包含在MOP中，MOP与研究主席和数据协调中心申请一起单独提交。除了Nova Southeastern University College of Optography，还有另外8个验光/眼科中心，宾夕法尼亚验光学院的研究主席和俄亥俄州州立大学验光协调中心的数据协调中心。

DESCRIPTION (provided by applicant): This proposal is for the Nova Southeastern College of Optometry (NSU) to serve as one of 9 clinical 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 for patients with convergence insufficiency (CI). This proposal is for the Nova Southeastern College of Optometry (NSU) 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 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, and 4) office-based Pencil Push-up therapy. Measurements of the signs and symptoms of CI will be made at baseline, and by masked examiners after every 4 weeks of treatment during the 12-week treatment phase. Patients who are successful after 12 weeks of treatment will be followed for an additional 12 months. The primary outcome measure is the score on the Convergence Insufficiency Symptom Survey. Secondary outcome measures will include the near point of convergence and positive fusional vergence at near. Our objective at this Clinical Center will be to enroll at least 45 patients in the 24-month recruitment period. This application documents the ability of Nova Southeastern University 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 after completion of treatment. Documentation is also provided that the Nova Southeastern University College of Optometry has the personnel, 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 the Nova Southeastern University College of Optometry, there will be 8 other optometric/ophthalmologic centers with the Study Chair at the Pennsylvania College of Optometry and the Data Coordinating Center at the Ohio State University Optometry Coordinating Center.