Bicanalicular Silicone Stents in Endonasal Dacryocystorhinostomy: Results of a Randomized Clinical Trial

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• 作者：Tessa Fayers ; FRCOphth¹ ; ² ; Peter J. Dolman ; MD ; FRCSC¹ ; ^{peterdolman@hotmail.com" class="auth_mail" title="E-mail the corresponding author}
• 关键词：CI ; confidence interval ; DCR ; dacryocystorhinostomy ; EN-DCR ; endonasal dacryocystorhinostomy
• 刊名：Ophthalmology
• 出版年：2016
• 出版时间：October 2016
• 年：2016
• 卷：123
• 期：10
• 页码：2255-2259
• 全文大小：174 K

文摘

To assess whether the use of silicone lacrimal stents affects the long-term success of endonasal dacryocystorhinostomy (EN-DCR).

Design

Prospective, randomized, controlled, interventional trial.

Participants

The subjects were adult patients older than 16 years undergoing primary EN-DCR for nasolacrimal duct obstruction who gave fully informed consent and who had no lid malpositions or canalicular pathology. In cases with bilateral surgery, only the right eyes were studied. Participants were randomized to receive stents (control group) or not (study group).

Methods

Standardized nonendoscopic EN-DCR was performed by the senior author in all cases. When the ostium was completed, the randomization code was revealed as to whether a lacrimal stent was placed or not. Follow-up assessments were made at 3, 6, 9, and 12 months. Stents were removed at 3 months.

Main Outcome Measures

The primary end point was symptoms of epiphora at 12 months, reported to the surgical booking clerk as (a) resolved, (b) significantly improved, (c) partially improved, or (d) no change or worse. The secondary end point was anatomic patency based on nasolacrimal syringing and categorized as (a) fully patent, minimal, or no reflux; (b) >50% patent but some reflux; (c) some patency but >50% reflux; or (d) nonpatent, 100% reflux. Complete success was defined as having resolved or significantly improved symptoms of watering and minimal or no reflux on nasolacrimal syringing. Partial success was defined as symptoms partially improved with a combination of patency and reflux on syringing. Failure was categorized as no change or worse symptoms of watering and 50% to 100% reflux on syringing.

Results

A total of 300 patients completed 12 months of follow-up. A total of 152 patients received tubes, and 148 patients did not. Overall success both subjectively and objectively was 94.7% in the stented group and 87.8% in the nonstented group (P = 0.034, Pearson chi-square 1-tailed test). The most common complications of stents included canalicular cheese-wiring and tube prolapse in approximately 4% each.

Conclusions

There is a statistically significantly higher success rate in EN-DCR surgery with tubes compared with no tubes. The failure rate in this study was more than twice as high when tubes were not used (12.2% vs. 5.3%).