Optometry, Illinois College of Optometry, Chicago, IL, USA.
Sunderland Eye Infirmary, Sunderland, UK.
Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD003737. doi: 10.1002/14651858.CD003737.pub4.
BACKGROUND: The clinical management of intermittent exotropia (X(T)) has been discussed extensively in the literature, yet there remains a lack of clarity regarding indications for intervention, the most effective form of treatment, and whether there is an optimal time in the evolution of the disease at which any given treatment should be carried out. OBJECTIVES: The objective of this review was to analyze the effects of various surgical and non-surgical treatments in randomized controlled trials (RCTs) of participants with intermittent exotropia, and to report intervention criteria and determine whether the treatment effect varies by age and subtype of X(T). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 1), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Ovid Embase; Latin American and Caribbean Health Science Information database (LILACS); the ISRCTN registry; ClinicalTrials.gov, and the WHO ICTRP. The date of the search was 20 January 2021. We performed manual searches of the British Orthoptic Journal up to 2002, and the proceedings of the European Strabismological Association (ESA), International Strabismological Association (ISA), and American Association for Pediatric Ophthalmology and Strabismus meeting (AAPOS) up to 2001. SELECTION CRITERIA: We included RCTs of any surgical or non-surgical treatment for intermittent exotropia. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. MAIN RESULTS: We included six RCTs, four of which took place in the United States, and the remaining two in Asia (Turkey, India). A total of 890 participants with basic or distance X(T) were included, most of whom were children aged 12 months to 10 years. Three of these six studies were from the 2013 version of this review. Overall, the included studies had a high risk of performance bias as masking of participants and personnel administering treatment was not possible. Two RCTs compared bilateral lateral rectus recession versus unilateral lateral rectus recession with medial rectus resection, but only one RCT (n = 197) reported on the primary outcomes of this review. Bilateral lateral rectus recession likely results in little difference in motor alignment at near (MD 1.00, 95% CI -2.69 to 4.69) and distance (MD 2.00, 95% CI -1.22 to 5.22) fixation as measured in pupillary distance using PACT (moderate-certainty evidence). Bilateral lateral rectus recession may result in little to no difference in stereoacuity at near fixation (risk ratio (RR) 0.77, 95% CI 0.35 to 1.71), adverse events (RR 7.36, 95% CI 0.39 to 140.65), or quality of life measures (low-certainty evidence). We conducted a meta-analysis of two RCTs comparing patching (n = 249) with active observation (n = 252), but were unable to conduct further meta-analyses due to the clinical and methodological heterogeneity in the remaining trials. We found evidence that patching was clinically more effective than active observation in improving motor alignment at near (mean difference (MD) -2.23, 95% confidence interval (CI) -4.02 to -0.44) and distance (MD -2.00, 95% CI -3.40 to -0.61) fixation as measured by prism and alternate cover test (PACT) at six months (high-certainty evidence). The evidence suggests that patching results in little to no difference in stereoacuity at near fixation (MD 0.00, 95% CI -0.07 to 0.07) (low-certainty evidence). Stereoacuity at distance, motor fusion test, and quality of life measures were not reported. Adverse events were also not reported, but study authors explained that they were not anticipated due to the non-surgical nature of patching. One RCT (n = 38) compared prism adaptation test with eye muscle surgery versus eye muscle surgery alone. No review outcomes were reported. One RCT (n = 60) compared lateral rectus recession and medial rectus plication versus lateral rectus recession and medial rectus resection. Lateral rectus recession and medial rectus plication may not improve motor alignment at distance (MD 0.66, 95% CI -1.06 to 2.38) (low-certainty evidence). The evidence for the effect of lateral rectus recession and medial rectus plication on motor fusion test performance is very uncertain (RR 0.92, 95% CI 0.48 to 1.74) (very low-certainty evidence). AUTHORS' CONCLUSIONS: Patching confers a clinical benefit in children aged 12 months to 10 years of age with basic- or distance-type X(T) compared with active observation. There is insufficient evidence to determine whether interventions such as bilateral lateral rectus recession versus unilateral lateral rectus recession with medial rectus resection; lateral rectus recession and medial rectus plication versus lateral rectus recession and medial rectus resection; and prism adaptation test prior to eye muscle surgery versus eye muscle surgery alone may confer any benefit.
背景:间歇性外斜视 (X(T)) 的临床管理在文献中已有广泛讨论,但对于干预的适应证、最有效的治疗形式以及在疾病演变过程中何时进行任何特定治疗效果最佳,仍存在不明确之处。
目的:本综述的目的是分析随机对照试验 (RCT) 中各种手术和非手术治疗间歇性外斜视的效果,并报告干预标准,确定治疗效果是否因年龄和 X(T) 亚型而异。
检索方法:我们检索了 Cochrane 中心对照试验注册库 (CENTRAL; 2021 年第 1 期),其中包含 Cochrane 眼科和视觉试验注册库;Ovid MEDLINE;Ovid Embase;拉丁美洲和加勒比健康科学信息数据库 (LILACS);ISRCTN 注册库;ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台 (WHO ICTRP)。检索日期为 2021 年 1 月 20 日。我们对英国斜视杂志 (British Orthoptic Journal) 截至 2002 年的内容进行了手动检索,并对欧洲斜视协会 (European Strabismological Association)、国际斜视协会 (International Strabismological Association) 和美国小儿眼科和斜视协会 (American Association for Pediatric Ophthalmology and Strabismus) 会议的会议记录 (AAPOS) 进行了截至 2001 年的检索。
入选标准:我们纳入了任何针对间歇性外斜视的手术或非手术治疗的 RCT。
数据收集和分析:我们遵循了标准的 Cochrane 方法。
主要结果:我们纳入了 6 项 RCT,其中 4 项在美国进行,其余 2 项在亚洲 (土耳其、印度) 进行。共有 890 名患有基本型或远距离型 X(T) 的参与者入选,其中大多数是 12 个月至 10 岁的儿童。这 6 项研究中有 3 项来自本综述的 2013 年版本。总体而言,由于无法对参与者和实施治疗的人员进行掩蔽,这些研究的偏倚风险很高。其中两项 RCT 比较了双侧外直肌后退术与单侧外直肌后退术联合内直肌切除术,但只有一项 RCT (n = 197) 报告了本综述的主要结局。双侧外直肌后退术在近距 (MD 1.00,95%CI -2.69 至 4.69) 和远距 (MD 2.00,95%CI -1.22 至 5.22) 固视时,在瞳孔距离上使用 PACT 测量,运动对准可能差异不大 (中等确定性证据)。双侧外直肌后退术可能对近距固视时的立体视锐度 (RR 0.77,95%CI 0.35 至 1.71)、不良事件 (RR 7.36,95%CI 0.39 至 140.65) 或生活质量测量 (低确定性证据) 没有差异或差异很小。我们对 2 项 RCT 进行了荟萃分析,比较了遮盖 (n = 249) 与主动观察 (n = 252),但由于其余试验的临床和方法学异质性,我们无法进行进一步的荟萃分析。我们发现证据表明,与主动观察相比,遮盖在改善近距 (MD -2.23,95%置信区间 (CI) -4.02 至 -0.44) 和远距 (MD -2.00,95%CI -3.40 至 -0.61) 固视时的运动对准方面更有效,测量方法为棱镜和交替遮盖试验 (PACT),在 6 个月时 (高确定性证据)。证据表明,遮盖在近距固视时的立体视锐度 (MD 0.00,95%CI -0.07 至 0.07) 上差异不大 (低确定性证据)。远距立体视、运动融合试验和生活质量测量未报告。不良事件也未报告,但研究作者解释说,由于遮盖是非手术性质的,因此预计不会发生。一项 RCT (n = 38) 比较了棱镜适应试验与眼肌手术和单纯眼肌手术。没有报告研究结果。一项 RCT (n = 60) 比较了外直肌后退术和内直肌缩短术与外直肌后退术和内直肌切除术。外直肌后退术和内直肌缩短术可能不会改善远距的运动对准 (MD 0.66,95%CI -1.06 至 2.38) (低确定性证据)。外直肌后退术和内直肌缩短术对运动融合试验性能影响的证据非常不确定 (RR 0.92,95%CI 0.48 至 1.74) (极低确定性证据)。
作者结论:与主动观察相比,12 个月至 10 岁的儿童患有基本型或远距离型 X(T) 时,遮盖可提供临床获益。目前尚不清楚干预措施(如双侧外直肌后退术与单侧外直肌后退术联合内直肌切除术;外直肌后退术和内直肌缩短术与外直肌后退术和内直肌切除术;以及棱镜适应试验在前眼肌手术与单纯眼肌手术)是否有益。
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