Departments of Epidemiology and Prevention and Ophthalmology, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA.
JAMA Ophthalmol. 2013 Mar;131(3):294-301. doi: 10.1001/jamaophthalmol.2013.910.
To determine whether a new surgical clamp reduces unfavorable postoperative outcomes.
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.
Postoperative TT, pyogenic granuloma formation, and eyelid contour abnormalities, combined and individually.
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).
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.
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.
clinicaltrials.gov Identifier: NCT00886015.
确定一种新型手术夹是否能降低不良术后结局。
将沙眼性倒睫（TT）患者随机分为采用标准双层睑板旋转（BLTR）仪器的手术组和 TT 夹手术组，并进行为期 2 年的随访。
术后 TT、化脓性肉芽肿形成和眼睑轮廓异常的综合和单独发生率。
共纳入 1917 名接受手术（3345 只眼）的参与者。接受 TT 夹手术的参与者与接受标准 BLTR 手术的参与者的至少 1 种不良结局发生率相似（分别为 60.9%和 63.0%；调整后的优势比[OR]为 0.88；95%置信区间，0.66-1.18）。肉芽肿在 TT 夹组中比在标准 BLTR 组中更少见（分别为 16.8%和 22.4%；OR=0.67；95%置信区间，0.46-0.97）。与标准 BLTR 组相比，TT 夹组术后 TT 有增加趋势（分别为 43.2%和 36.6%；OR=1.36；95%置信区间，0.96-1.93）。与标准 BLTR 相比，TT 夹降低了轻度眼睑轮廓异常的风险（分别为 9.1%和 13.3%；OR=0.64；95%置信区间，0.42-0.97），且中度异常的发生率也有降低趋势（分别为 5.3%和 7.8%；OR=0.63；95%置信区间，0.39-1.01）。
总体而言，两组间不良结局发生率相似。尽管我们的结果与其他计划性环境相似，但如此高的不良结局率是不可接受的；需要进一步研究以确定改善 TT 手术结局的方法。
一种新的 TT 手术夹似乎可以预防肉芽肿形成和某些眼睑轮廓异常，但不能降低术后 TT。
clinicaltrials.gov 标识符：NCT00886015。
