Pennsylvania College of Optometry, 1200 West Godfrey Ave, Philadelphia, PA 19141, USA.
Ophthalmic Epidemiol. 2008 Jan-Feb;15(1):24-36. doi: 10.1080/09286580701772037.
This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. We also report the clinical and demographic characteristics of patients.
We prospectively randomized children 9 to 17 years of age to one of four treatment groups: 1) home-based pencil push-ups, 2) home-based computer vergence/accommodative therapy and pencil push-ups, 3) office-based vergence/accommodative therapy with home reinforcement, 4) office-based placebo therapy. Outcome data on the Convergence Insufficiency Symptom Survey (CISS) score (primary outcome), near point of convergence (NPC), and positive fusional vergence were collected after 12 weeks of active treatment and again at 6 and 12 months posttreatment.
The CITT enrolled 221 children with symptomatic CI with a mean age of 12.0 years (SD = +2.3). The clinical profile of the cohort at baseline was 9Delta exophoria at near (+/- 4.4) and 2Delta exophoria (+/-2.8) at distance, CISS score = 30 (+/-9.0), NPC = 14 cm (+/- 7.5), and near positive fusional vergence break = 13 Delta (+/- 4.6). There were no statistically significant nor clinically relevant differences between treatment groups with respect to baseline characteristics (p > 0.05).
Hallmark features of the study design include formal definitions of conditions and outcomes, standardized diagnostic and treatment protocols, a placebo treatment arm, masked outcome examinations, and the CISS score outcome measure. The baseline data reported herein define the clinical profile of those enrolled into the CITT.
本报告描述了集合不足治疗试验（CITT）的设计和方法，这是首个评估儿童集合不足（CI）治疗方法的大规模、安慰剂对照、随机临床试验。我们还报告了患者的临床和人口统计学特征。
我们将9至17岁的儿童前瞻性地随机分为四个治疗组之一：1）家庭式铅笔俯卧撑训练；2）家庭式电脑集合/调节训练及铅笔俯卧撑训练；3）办公室式集合/调节训练并辅以家庭强化训练；4）办公室式安慰剂治疗。在积极治疗12周后以及治疗后6个月和12个月时，收集集合不足症状调查（CISS）评分（主要结局）、集合近点（NPC）和正融合性集合的结局数据。
CITT招募了221名有症状的CI儿童，平均年龄为12.0岁（标准差=+2.3）。该队列在基线时的临床特征为近距9棱镜度外斜视（±4.4）、远距离2棱镜度外斜视（±2.8），CISS评分为30（±9.0），NPC为14厘米（±7.5），近距正融合性集合破裂为13棱镜度（±4.6）。各治疗组在基线特征方面无统计学显著差异，也无临床相关差异（p>0.05）。
该研究设计的标志性特征包括对疾病和结局的正式定义、标准化的诊断和治疗方案、一个安慰剂治疗组、盲法结局检查以及CISS评分结局指标。本文报告的基线数据定义了纳入CITT的患者的临床特征。
