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双侧外直肌后退术与单侧后退-截除术治疗基本型间歇性外斜视的随机对照试验

A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia.

机构信息

Department of Ophthalmology and Visual Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.

Jaeb Center for Health Research, Tampa, Florida.

出版信息

Ophthalmology. 2019 Feb;126(2):305-317. doi: 10.1016/j.ophtha.2018.08.034. Epub 2018 Sep 3.

Abstract

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.

摘要

目的

比较双眼外直肌后退术(BLRc)与同眼单侧外直肌后退联合内直肌切除术(R&R)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。

参与者

197 名 3 岁以下且患有基本型 IXT 的儿童,斜视度最大时棱镜和交替遮盖试验在 15 至 40 棱镜屈光度(PD)范围内,近距立体视锐度至少为 400 秒弧。

方法

BLRc 或 R&R 随机分组,术后 3 年内每 6 个月进行一次隐蔽检查。

主要观察指标

3 年内手术结果不理想的参与者比例,定义为:(1)使用同时性棱镜和遮盖试验(SPCT)时,远距或近距斜视 10 PD 或以上;(2)远距或近距使用 SPCT 时,恒定性内斜视 6 PD 或以上;(3)从基线开始,任何隐蔽检查中立体视锐度损失 2 个以上 octaves;(4)未达到任何上述标准而再次手术。

结果

3 年内手术结果不理想的累积概率为 BLRc 组 46%(43/101),R&R 组 37%(33/96)(BLRc 组减去 R&R 组的治疗组差异为 9%;95%置信区间[CI],-6%至 23%)。3 年内再次手术的患者有 9 例(10%)在 BLRc 组(其中 8 例符合手术结果不理想标准),4 例(5%)在 R&R 组(其中 3 例符合手术结果不理想标准;BLRc 组减去 R&R 组的治疗组差异为 5%;95%CI,-2%至 13%)。在完成 3 年随访的参与者中,BLRc 组有 29%(25/86)和 R&R 组有 17%(13/77)在 3 年内再次手术或达到手术结果不理想的标准(BLRc 组减去 R&R 组的治疗组差异为 12%;95%CI,-1%至 25%)。

结论

我们没有发现 3 年内 BLRc 治疗与 R&R 治疗 IXT 儿童的手术结果不理想有统计学差异。基于这些发现,我们无法推荐一种手术方法优于另一种用于儿童 IXT。

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