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首页> 外文期刊>Ophthalmology >Randomized clinical trial of a new dexamethasone delivery system (Surodex) for treatment of post-cataract surgery inflammation.
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Randomized clinical trial of a new dexamethasone delivery system (Surodex) for treatment of post-cataract surgery inflammation.

机译：新的地塞米松输送系统（Surodex）用于治疗白内障术后炎症的随机临床试验。

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OBJECTIVE: To evaluate the safety of Surodex Drug Delivery System (Oculex Pharmaceuticals, Inc., Sunnyvale, CA) containing dexamethasone 60 micrograms, for use in cataract surgery, and to compare its anti-inflammatory efficacy with conventional dexamethasone 0.1% eyedrops. DESIGN: Randomized, masked, and partially controlled trial. PARTICIPANTS: Sixty eyes of 60 Asian patients undergoing extracapsular cataract extraction with intraocular lens implantation were examined. Of these, 28 eyes of 28 patients served as control eyes. Patients were stratified for age and presence of diabetes mellitus. INTERVENTION: Surodex was inserted in the anterior chamber of 32 eyes at the conclusion of surgery. These eyes received placebo eyedrops four times a day after surgery for 4 weeks. Control eyes received neither Surodex nor a placebo implant but were prescribed conventional 0.1% dexamethasone eyedrops four times a day for 4 weeks. MAIN OUTCOME MEASURES: Anterior chamber cells and flare were clinically graded at the slit lamp. Anterior chamber flare was objectively assessed with the Kowa FM500 Laser Flare Meter (Kowa Co. Ltd, Tokyo, Japan) for up to 3 months after surgery. Intraocular pressure and corneal endothelial specular microscopy with morphometric cell analysis were performed for up to 1 year after surgery. RESULTS: Clinical slit-lamp assessment of anterior chamber flare and cells showed no difference between Surodex-treated eyes and dexamethasone eyedrop-treated eyes. Flare meter readings showed lower flare levels in the Surodex group at all postoperative visits compared with the dexamethasone eyedrop group. Flare reduction in the Surodex group reached statistical significance at days 4, 8, 15, and 30 after surgery. At 3 months, flare was reduced to preoperative levels in the Surodex group but was still raised in the dexamethasone eyedrop group. Five eyes in the dexamethasone eyedrop group required augmentation of steroids and were deemed therapeutic failures as opposed to one eye in the Surodex group. One patient in the dexamethasone eyedrop group developed postoperative open-angle glaucoma with profound visual field loss and optic disc cupping, resulting in hand movements vision. No significant difference in endothelial cell loss was noted between Surodex-inserted eyes and dexamethasone eyedrop-treated eyes for up to 1 year after surgery. CONCLUSIONS: Intraocular placement of a single Surodex is a safe and effective treatment method to reduce intraocular inflammation after cataract surgery. There was no statistical difference in efficacy between Surodex and 0.1% dexamethasone eyedrops in reducing intraocular inflammation, as measured by clinical methods, while Surodex was clearly superior to eyedrops in reducing aqueous flare as objectively assessed with the laser flare meter.
机译：目的：评估包含地塞米松60微克的Surodex药物输送系统（Oculex制药公司，加利福尼亚州桑尼维尔）的安全性，并将其用于白内障手术，并将其与传统0.1％地塞米松滴眼液的抗炎效果进行比较。设计：随机，掩盖和部分对照的试验。研究对象：60名亚洲人患者中有60只眼睛接受了白内障囊外摘除并人工晶状体植入术。其中，28例患者的28眼用作对照眼。根据年龄和糖尿病的存在对患者进行分层。干预：手术结束时将Surodex插入32只眼的前房。这些眼睛在术后4周中每天接受四次安慰剂眼药水。对照眼既未接受Surodex也未接受安慰剂植入，但按常规常规0.1％地塞米松滴眼液治疗，每周四次，共4周。主要观察指标：裂隙灯在临床上对前房细胞和耀斑进行了分级。在手术后长达3个月的时间里，使用Kowa FM500激光耀斑仪（日本东京Kowa Co. Ltd）客观地评估了前房耀斑。术后一年内进行眼压和角膜内皮镜检及形态细胞分析。结果：对前房耀斑和细胞进行的裂隙灯临床评估显示，经Surodex治疗的眼睛与地塞米松滴眼液治疗的眼睛之间无差异。与地塞米松滴眼液组相比，在所有术后就诊的Surodex组的眩光仪读数均显示较低的眩光水平。 Surodex组的耀斑减少在术后第4、8、15和30天达到统计学意义。在3个月时，Surodex组的耀斑减少至术前水平，而地塞米松滴眼液组仍然升高。地塞米松滴眼液组中的五只眼需要增加类固醇，与Surodex组的一只眼相反，被认为治疗失败。地塞米松滴眼液组的一名患者发生了术后开角型青光眼，并伴有严重的视野丧失和视盘拔罐，从而导致手部运动。在手术后长达1年的时间里，插入Surodex的眼睛和地塞米松滴眼液治疗的眼睛之间的内皮细胞损失没有显着差异。结论：眼内放置单个Surodex是减少白内障手术后眼内炎症的安全有效的治疗方法。通过临床方法测量，Suredex和0.1％地塞米松滴眼液在减少眼内炎症方面的疗效无统计学差异，而用激光耀斑仪客观评估，Suredex明显优于滴眼剂在减少眼水肿方面。

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