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A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia.
Ophthalmology ( IF 13.7 ) Pub Date : 2018-09-03 , DOI: 10.1016/j.ophtha.2018.08.034
, , Sean P Donahue 1 , Danielle L Chandler 2 , Jonathan M Holmes 3 , Brian W Arthur 4 , Evelyn A Paysse 5 , David K Wallace 6 , David B Petersen 7 , B Michele Melia 2 , Raymond T Kraker 2 , Aaron M Miller 8
Affiliation  

PURPOSE To compare long-term outcomes after bilateral lateral rectus recession (BLRc) or unilateral lateral rectus recession combined with medial rectus resection in the same eye (R&R) for primary treatment of childhood intermittent exotropia (IXT). DESIGN Multicenter, randomized clinical trial. PARTICIPANTS One hundred ninety-seven children 3 to younger than 11 years of age with basic-type IXT, a largest deviation by prism and alternate cover test at any distance of 15 to 40 prism diopters (PD), and near stereoacuity of at least 400 seconds of arc. METHODS Random assignment to BLRc or R&R and masked examinations conducted every 6 months after surgery for 3 years. MAIN OUTCOME MEASURES Proportion of participants meeting suboptimal surgical outcome by 3 years, defined as: (1) exotropia of 10 PD or more at distance or near using simultaneous prism and cover test (SPCT); or (2) constant esotropia of 6 PD or more at distance or near using SPCT; (3) loss of 2 octaves or more of stereoacuity from baseline, at any masked examination; or (4) reoperation without meeting any of these criteria. RESULTS Cumulative probability of suboptimal surgical outcome by 3 years was 46% (43/101) in the BLRc group versus 37% (33/96) in the R&R group (treatment group difference of BLRc minus R&R, 9%; 95% confidence interval [CI], -6% to 23%). Reoperation by 3 years occurred in 9 participants (10%) in the BLRc group (8 of 9 met suboptimal surgical outcome criteria) and in 4 participants (5%) in the R&R group (3 of 4 met suboptimal surgical outcome criteria; treatment group difference of BLRc minus R&R, 5%; 95% CI, -2% to 13%). Among participants completing the 3-year visit, 29% (25 of 86) in the BLRc group and 17% (13 of 77) in the R&R group underwent reoperation or met suboptimal surgical outcome criteria at 3 years (treatment group difference of BLRc minus R&R, 12%; 95% CI, -1% to 25%). CONCLUSIONS We did not find a statistically significant difference in suboptimal surgical outcome by 3 years between children with IXT treated with BLRc compared with those treated with R&R. Based on these findings, we are unable to recommend one surgical approach over the other for childhood IXT.

中文翻译:

基本类型的间歇性外斜视比较双侧外侧直肌凹陷与单侧凹陷和切除的随机对照试验。

目的比较双侧外侧直肌凹陷(BLRc)或单侧外侧直肌凹陷与同一只眼的内侧直肌切除术(R&R)联合治疗儿童间歇性外斜视(IXT)的长期疗效。设计多中心随机临床试验。参加者177名年龄在3岁至11岁之间的儿童,患有基本型IXT,在15至40棱镜屈光度(PD)的任何距离下,通过棱镜和交替掩膜测试的最大偏差,并且近视度数至少为400弧秒。方法随机分配BLRc或R&R,并在术后3年每6个月进行一次假面检查。主要观察指标:达到3年手术效果欠佳的参与者的比例,定义为:(1)使用同时棱镜和掩盖试验(SPCT)在远处或近处具有10 PD或更大的屈光性 或(2)使用SPCT,在远距离或近距离时恒定的内斜视为6 PD或更高;(3)在任何掩盖检查中,从基线丧失了两个八度音阶或更多的立体视力;或(4)不符合任何上述标准的再次手术。结果BLRc组3年次佳手术结局的累积概率为46%(43/101),而R&R组为37%(33/96)(治疗组BLRc减去R&R的差异为9%;置信区间为95% [CI],从-6%到23%)。BLRc组中的9名参与者(10%)达到了3年的再次手术(9符合次优手术结果标准),R&R组的4名参与者(4符合次优手术结果标准3%)(治疗组) BLRc减去R&R的差异,5%; 95%CI,-2%到13%)。在完成3年随访的参与者中,BLRc组29%(86个中的25个)和R&R组17%(77个中的13个)在3年时接受了再次手术或达到次优手术结果标准(治疗组BLRc减去负值) R&R,12%; 95%CI,-1%至25%)。结论我们发现,在3年内,接受BLRc治疗的IXT儿童与接受R&R治疗的IXT儿童在次优手术结局方面没有统计学上的显着差异。基于这些发现,对于儿童IXT,我们无法推荐一种手术方法。-1%到25%)。结论我们发现,在3年内,接受BLRc治疗的IXT儿童与接受R&R治疗的IXT儿童在次优手术结局方面没有统计学上的显着差异。基于这些发现,对于儿童IXT,我们无法推荐一种手术方法。-1%到25%)。结论我们发现,在3年内,接受BLRc治疗的IXT儿童与接受R&R治疗的IXT儿童在次优手术结局方面没有统计学上的显着差异。基于这些发现,对于儿童IXT,我们无法推荐一种手术方法。
更新日期:2018-09-03
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