Department of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Ophthalmology, Pepose Vision Institute, Chesterfield, MO, USA.
Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD004917. doi: 10.1002/14651858.CD004917.pub4.
Infantile esotropia (IE) is the inward deviation of the eye. Various aspects of the clinical management of IE are unclear; mainly, the most effective type of intervention and the age at intervention.
To examine the effectiveness and optimal timing of surgical and non-surgical treatment options for IE to improve ocular alignment and achieve or allow the development of binocular single vision.
We searched CENTRAL, MEDLINE, Embase, one other database, and three trials registers (November 2021). We did not use any date or language restrictions in the electronic searches for trials. SELECTION CRITERIA: We included randomized trials and quasi-randomized trials comparing any surgical or non-surgical intervention for IE.
We used standard Cochrane methodology and graded the certainty of the body of evidence for six outcomes using the GRADE classification.
We included two studies with 234 children with IE. The first study enrolled 110 children (mean age 26.9 ± 14.5 months) with an onset of esotropia before six months of age, and large-angle IE defined as esotropia of ≥ 40 prism diopters. It was conducted between 2015 and 2018 in a tertiary care hospital in South Africa. It compared a maximum of three botulinum toxin injections with surgical intervention of bimedial rectus muscle recession, and children were followed for six months. There were limitations in study design and implementation; the risk of bias was high, or we had some concerns for most domains. Surgery may increase the incidence of treatment success, defined as orthophoria or residual esotropia of ≤ 10 prism diopters, compared with botulinum toxin injections, but the evidence was very uncertain (risk ratio (RR) of treatment success 1.88, 95% confidence interval (CI) 1.27 to 2.77; 1 study, 101 participants; very low-certainty evidence). The results should be read with caution because 23 children with > 60 prism diopters at baseline in the surgery arm also received botulinum toxin at the time of surgery to augment the recessions. There was no evidence of an important difference between surgery and botulinum toxin injections for over-correction (> 10 prism diopters) of deviation (RR 0.29, 95% CI 0.06 to 1.37; 1 study, 101 participants; very low-certainty evidence), or additional interventions required (RR 0.66, 95% CI 0.36 to 1.19; 1 study, 101 participants; very low-certainty evidence). No major complications of surgery were observed in the surgery arm, while children experienced various complications in the botulinum toxin arm, including partial transient ptosis in 9 (16.7%) children, transient vertical deviation in 3 (5.6%) children, and consecutive exotropia in 13 (24.1%) children. No other outcome data for our prespecified outcomes were reported. The second study enrolled 124 children with onset of esotropia before one year of age in 12 university hospitals in Germany and the Netherlands. It compared bilateral recession with unilateral recession surgeries, and followed children for three months postoperatively. Very low-certainty evidence suggested that there was no evidence of an important difference between bilateral and unilateral surgeries in the presence of binocular vision (numbers with event unclear, P = 0.35), and over-correction (RR of having exotropia 1.09, 95% CI 0.45 to 2.63; 1 study, 118 participants). Dissociated vertical deviation, latent nystagmus, or both were observed in 8% to 21% of participants.
AUTHORS' CONCLUSIONS: Medial rectus recessions may increase the incidence of treatment success compared with botulinum toxin injections alone, but the evidence was very uncertain. No evidence of important difference was found between bilateral surgery and unilateral surgery. Due to insufficient evidence, it was not possible to resolve the controversies regarding type of surgery, non-surgical intervention, or age of intervention in this review. There is clearly a need to conduct good quality trials in these areas to improve the evidence base for the management of IE.
婴儿性内斜视(IE)是眼睛向内的偏斜。IE 临床管理的各个方面尚不清楚;主要是最有效的干预类型和干预年龄。
研究 IE 的手术和非手术治疗选择的有效性和最佳时机,以改善眼球对准并实现或允许双眼单视的发展。
我们检索了 CENTRAL、MEDLINE、Embase、一个其他数据库和三个试验登记处(2021 年 11 月)。我们在电子检索中没有对试验使用任何日期或语言限制。
我们纳入了比较 IE 任何手术或非手术干预的随机试验和准随机试验。
我们使用了标准的 Cochrane 方法,并使用 GRADE 分类对六个结局的证据体进行了确定性分级。
我们纳入了两项研究,共纳入 234 名 IE 患儿。第一项研究纳入了 110 名(平均年龄 26.9±14.5 个月)发病年龄在 6 个月以内的患儿,以及大角度 IE(定义为斜视度≥40 棱镜度)。该研究于 2015 年至 2018 年在南非的一家三级保健医院进行。该研究比较了最大三次肉毒杆菌毒素注射与双内直肌后退手术的治疗效果,随访时间为 6 个月。研究设计和实施存在局限性;偏倚风险高,或我们对大多数领域都存在一些担忧。与肉毒杆菌毒素注射相比,手术可能会增加治疗成功的发生率,定义为正位或残余斜视度≤10 棱镜度,但证据非常不确定(治疗成功率的 RR 为 1.88,95%CI 为 1.27 至 2.77;1 项研究,101 名参与者;极低确定性证据)。由于手术组中基线斜视度>60 棱镜度的 23 名儿童在手术时也接受了肉毒杆菌毒素注射来增强后退,因此结果应谨慎解读。手术和肉毒杆菌毒素注射之间没有证据表明在过矫正(>10 棱镜度)(RR 0.29,95%CI 0.06 至 1.37;1 项研究,101 名参与者;极低确定性证据)或需要额外干预(RR 0.66,95%CI 0.36 至 1.19;1 项研究,101 名参与者;极低确定性证据)方面存在重要差异。手术组未观察到手术的严重并发症,而肉毒杆菌毒素组的儿童经历了各种并发症,包括 9 名(16.7%)儿童出现部分短暂性上睑下垂、3 名(5.6%)儿童出现短暂性垂直斜视和 13 名(24.1%)儿童出现连续外斜视。没有报告我们预设结局的其他结局数据。
第二项研究纳入了 124 名发病年龄在 1 岁以内的患儿,这些患儿来自德国和荷兰的 12 家大学医院。它比较了双侧后退与单侧后退手术,术后随访 3 个月。非常低确定性证据表明,在存在双眼视觉的情况下,双侧手术与单侧手术之间没有证据表明有重要差异(事件人数不清楚,P=0.35),并且过矫正(RR 发生外斜视的比值为 1.09,95%CI 为 0.45 至 2.63;1 项研究,118 名参与者)。8%至 21%的参与者出现分离性垂直偏斜、潜伏性眼球震颤或两者兼有。
与单独使用肉毒杆菌毒素注射相比,内侧直肌后退可能会增加治疗成功的几率,但证据非常不确定。双侧手术与单侧手术之间没有发现重要差异。由于证据不足,无法解决本综述中手术类型、非手术干预或干预年龄方面的争议。显然,需要在这些领域进行高质量的试验,以提高 IE 管理的证据基础。