Hassan Shoaib, Haridas Anjana, Sundaram Venki
University Hospital of Wales, Heath Park, Cardiff, UK, CF14 4XW.
Cochrane Database Syst Rev. 2018 Mar 12;3(3):CD004240. doi: 10.1002/14651858.CD004240.pub4.
Strabismus, or squint, can be defined as a deviation from perfect ocular alignment and can be classified in many ways according to its aetiology and presentation. Treatment can be broadly divided into medical and surgical options, with a variety of surgical techniques being available, including the use of adjustable or non-adjustable sutures for the extraocular muscles. There exists an uncertainty as to which of these techniques produces a better surgical outcome, and an opinion that the adjustable suture technique may be of greater benefit in certain situations.
To determine if either an adjustable suture or non-adjustable suture technique is associated with a more accurate long-term ocular alignment and to identify specific situations in which it would be of benefit to use a particular method.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 5); Ovid MEDLINE; Ovid Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and the ICTRP. The date of the search was 13 June 2017. We contacted experts in the field for further information.
We included only randomised controlled trials (RCTs) comparing adjustable to non-adjustable sutures for strabismus surgery.
We used standard procedures recommended by Cochrane. Two review authors independently screened search results and extracted data. We graded the certainty of the evidence using the GRADE approach.
We identified one RCT comparing adjustable and non-adjustable sutures in primary horizontal strabismus surgeries in 60 children aged less than 12 years in Egypt. The study was not masked and we judged it at high risk of detection bias. Ocular alignment was defined as orthophoria or a horizontal tropia of 8 prism dioptres (PD) or less at near and far distances. At six months, there may be a small increased chance of ocular alignment with adjustable sutures compared with non-adjustable sutures clinically, however, the confidence intervals (CIs) were wide and were compatible with an increased chance of ocular alignment in the non-adjustable sutures group, so there was no statistical difference (risk ratio (RR) 1.18, 95% CI 0.91 to 1.53). We judged this to be low-certainty evidence, downgrading for imprecision and risk of bias. At six months, 730 per 1000 children in the non-adjustable sutures group had ocular alignment. The study authors reported that there were no complications during surgery. The trials did not assess patient satisfaction and resource use and costs.
AUTHORS' CONCLUSIONS: We could reach no reliable conclusions regarding which technique (adjustable or non-adjustable sutures) produced a more accurate long-term ocular alignment following strabismus surgery or in which specific situations one technique is of greater benefit than the other, given the low-certainty and chance with just the one study. More high-quality RCTs are needed to obtain clinically valid results and to clarify these issues. Such trials should ideally 1. recruit participants with any type of strabismus or specify the subgroup of participants to be studied, for example, thyroid, paralytic, non-paralytic, paediatric; 2. randomise all consenting participants to have either adjustable or non-adjustable surgery prospectively; 3. have at least six months of follow-up data; and 4. include reoperation rates as an outcome measure.
斜视，即斜眼，可定义为眼位未能完全对齐，可根据其病因和表现以多种方式分类。治疗方法大致可分为药物治疗和手术治疗，有多种手术技术可供选择，包括用于眼外肌的可调节或不可调节缝线。目前尚不确定哪种技术能产生更好的手术效果，有一种观点认为可调节缝线技术在某些情况下可能更有益。
确定可调节缝线技术或不可调节缝线技术是否与更准确的长期眼位对齐相关，并确定使用特定方法有益的具体情况。
我们检索了Cochrane对照试验中心注册库（CENTRAL）（其中包含Cochrane眼科和视力试验注册库）（2017年第5期）；Ovid MEDLINE；Ovid Embase；LILACS；国际标准随机对照试验编号注册库；ClinicalTrials.gov和国际临床试验平台。检索日期为2017年6月13日。我们联系了该领域的专家以获取更多信息。
我们仅纳入了比较斜视手术中可调节缝线与不可调节缝线的随机对照试验（RCT）。
我们采用了Cochrane推荐的标准程序。两位综述作者独立筛选检索结果并提取数据。我们使用GRADE方法对证据的确定性进行分级。
我们在埃及一项针对60名12岁以下儿童的原发性水平斜视手术中，发现了一项比较可调节缝线与不可调节缝线的RCT。该研究未设盲，我们判定其存在较高的检测偏倚风险。眼位对齐定义为在近距离和远距离时为正位视或水平斜视度为8棱镜度（PD）或更小。在6个月时，与不可调节缝线相比，可调节缝线在临床上使眼位对齐的几率可能略有增加，然而，置信区间（CI）较宽，且与不可调节缝线组眼位对齐几率增加的情况相符，因此无统计学差异（风险比（RR）1.18，95%CI 0.91至1.53）。我们判定这是低确定性证据，因不精确性和偏倚风险而降级。在6个月时，不可调节缝线组每1000名儿童中有730名眼位对齐。研究作者报告手术期间无并发症。这些试验未评估患者满意度、资源使用和成本。
鉴于仅有一项研究且确定性较低且存在偶然性，我们无法就斜视手术后哪种技术（可调节或不可调节缝线）能产生更准确的长期眼位对齐，或在哪些具体情况下一种技术比另一种技术更有益得出可靠结论。需要更多高质量的RCT以获得临床有效的结果并阐明这些问题。此类试验理想情况下应：1. 招募任何类型斜视的参与者或指定要研究的参与者亚组，例如，甲状腺相关、麻痹性、非麻痹性、儿童斜视；2. 将所有同意参与的参与者前瞻性地随机分配接受可调节或不可调节手术；3. 至少有6个月的随访数据；4. 将再次手术率作为一项结局指标。
