Trachomatous Trichiasis Clamp vs Standard Bilamellar Tarsal Rotation Instrumentation for Trichiasis Surgery Results of a Randomized Clinical Trial
Trachomatous Trichiasis Clamp vs Standard Bilamellar Tarsal Rotation Instrumentation for Trichiasis Surgery Results of a Randomized Clinical Trial
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DOI：
10.1001/jamaophthalmol.2013.910
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发表时间：
2013-03-01
影响因子：
8.1
通讯作者：
Merbs, Shannath L.
中科院分区：
文献类型：
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作者：
Gower, Emily W.;West, Sheila K.;Merbs, Shannath L.
目的：确定一种新的手术夹具是否能减少手术后的不良结果。方法：将沙眼性倒睫患者随机分为两组，分别使用标准的双板颧骨旋转(BLTR)器械和手术夹具进行手术治疗。主要观察指标：术后并发症、化脓性肉芽肿形成和眼睑轮廓异常。结果：共有1917例(3345眼)患者接受手术。接受TT钳手术的参与者和接受标准BLTR手术的参与者至少有1个不良结局的发生率相似(分别为60.9%和63.0%；调整后的优势比[AOR]=0.88；95%CI，0.66-1.18)。TT钳夹臂肉芽肿发生率低于标准BLTR臂(16.8%比22.4%；AOR=0.67；95%CI，0.46~0.97)。TT钳夹组术后TT明显高于标准BLTR组(分别为43.2%和36.6%；AOR=1.36；95%CI为0.96~1.93)。与标准BLTR相比，TT钳可降低轻度眼睑轮廓异常的风险(分别为9.1%和13.3%；AOR=0.64；95%CI，0.42~0.97)，并有减少中度异常的趋势(分别为5.3%和7.8%；AOR=0.63；95%CI，0.39~1.01)。尽管我们的结果与其他方案设置相似，但如此高的不良率是不可接受的；还需要进一步的研究来确定改善TT手术结果的方法。临床应用：一种用于TT手术的新夹子似乎提供了对肉芽肿形成和一些眼皮轮廓异常的保护，但它不能减少术后TT。
Objective: To determine whether a new surgical clamp reduces unfavorable postoperative outcomes.Methods: Patients with trachomatous trichiasis (TT) were randomized to surgery with standard bilamellar tarsal rotation (BLTR) instrumentation or the TT clamp and were followed up for 2 years.Main Outcome Measures: Postoperative TT, pyogenic granuloma formation, and eyelid contour abnormalities, combined and individually.Results: A total of 1917 participants who had surgery (3345 eyes) were enrolled. Rates of at least 1 unfavorable outcome were similar for the participants who underwent surgery with the TT clamp and those who underwent surgery with standard BLTR (60.9% vs 63.0%, respectively; adjusted odds ratio [AOR] = 0.88; 95% CI, 0.66-1.18). Granuloma was less common in the TT clamp arm than in the standard BLTR arm (16.8% vs 22.4%, respectively; AOR = 0.67; 95% CI, 0.46-0.97). There was a trend toward increased postoperative TT in the TT clamp arm compared with the standard BLTR arm (43.2% vs 36.6%, respectively; AOR = 1.36; 95% CI, 0.96-1.93). The TT clamp decreased the risk of mild eyelid contour abnormalities compared with standard BLTR (9.1% vs 13.3%, respectively; AOR = 0.64; 95% CI, 0.42-0.97) and showed a trend for a decrease in moderate abnormalities (5.3% vs 7.8%, respectively; AOR = 0.63; 95% CI, 0.39-1.01).Conclusions: Overall, rates of unfavorable outcomes were similar between groups. Although our results are similar to other programmatic settings, such high rates of unfavorable outcomes are unacceptable; future research is needed to identify ways to improve TT surgery outcomes.Application to Clinical Practice: A new clamp for TT surgery appears to offer protection against granuloma formation and some eyelid contour abnormalities, but it does not reduce postoperative TT.