Eye Hospital and School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, Zhejiang, China.
National Clinical Research Center for Ocular Diseases, Wenzhou, Zhejiang, China.
Trials. 2022 Apr 11;23(1):289. doi: 10.1186/s13063-022-06246-4.
Intermittent exotropia (IXT) is the most common type of exotropia in China. Surgery is usually required to align the eye deviation to maintain or obtain better binocular visual function. However, there is a high rate of exodrift or recurrence in surgically treated patients. Orthoptic therapy is sometimes recommended for IXT patients after surgery. However, there is a lack of high-quality randomized controlled trials to prove that orthoptic therapy could be an effective supplement to surgical treatment for IXT patients. The main purpose of this study is to test the clinical effectiveness of orthoptic therapy in long-term stabilization of postoperative IXT patient. This report describes the design and methodology of the Intermittent Exotropia Postoperative Treatment Clinical Trial, which is the first large-sample, blank-controlled, randomized clinical trial.
A total of 136 IXT patients (aged 7 to 17 years) will be enrolled and assigned to the orthoptic therapy group or blank control group according to a simple randomization scheme. Patients in the orthoptic therapy group will receive at least 2 months of orthoptic therapy, such as anti-suppression, vergence, and accommodation training. Patients in the blank control group will receive only refractive correction. All enrolled patients will need regular follow-up observation until 24 months after surgery. The primary outcome will be the proportion of participants meeting suboptimal surgical outcomes in this 24-month follow-up, which is defined as (1) exodeviation of 10 prism diopters (PD) at distance or near using the simultaneous prism and cover test (SPCT) or (2) loss of 2 or more octaves of stereoacuity from baseline, at any masked follow-up visit examination. The secondary outcomes will be the exodeviation at distance and near using the simultaneous prism and alternate cover test (PACT), magnitude of fusional convergence, stereoacuity, and accommodation. Measurements will be taken at baseline and at the 6-, 12-, 18-, and 24-month follow-ups.
To the best of our knowledge, this will be the first prospective, randomized controlled study of orthoptic training in IXT patients after surgery. The aim of this work is to confirm the efficacy of orthoptic therapy in reducing the proportion of recurrence among IXT patients after surgery and improving binocular vision function.
Chinese Clinical Trial Registry ChiCTR1900026891 . Registered on 25 October 2019.
间歇性外斜视（IXT）是中国最常见的外斜视类型。手术通常用于矫正眼位以维持或获得更好的双眼视觉功能。然而，接受手术治疗的患者斜视复发率较高。斜视手术后有时会建议进行斜视矫正治疗。然而，目前缺乏高质量的随机对照试验来证明斜视矫正治疗对 IXT 患者的手术治疗是一种有效的补充。本研究的主要目的是检验斜视矫正治疗对术后 IXT 患者长期稳定的临床效果。本报告介绍了间歇性外斜视术后治疗临床试验的设计和方法，这是第一项大样本、空白对照、随机临床试验。
共纳入 136 例 IXT 患者（7 至 17 岁），根据简单随机分组方案将其分为斜视矫正治疗组或空白对照组。斜视矫正治疗组患者将接受至少 2 个月的斜视矫正治疗，如抑制、聚散和调节训练。空白对照组患者仅接受屈光矫正。所有入组患者均需要定期随访观察，直至术后 24 个月。主要结局为 24 个月随访时满足手术效果不佳的患者比例，定义为：（1）使用同视机三棱镜遮盖法（SPCT）时，远距或近距斜视 10 棱镜度（PD）；或（2）任意随访检查时，与基线相比，立体视锐度损失 2 个或更多 octaves。次要结局为使用同视机交替遮盖法（PACT）时的远距和近距斜视、融合聚散度、立体视锐度和调节幅度。测量将在基线以及 6、12、18 和 24 个月随访时进行。
据我们所知，这将是第一项关于斜视矫正训练对斜视手术后患者的前瞻性、随机对照研究。本研究的目的是确认斜视矫正治疗在降低斜视手术后患者复发率和改善双眼视觉功能方面的疗效。
中国临床试验注册中心 ChiCTR1900026891，于 2019 年 10 月 25 日注册。
