Tan D T, Chee S P, Lim L, Lim A S
Singapore National Eye Centre, Singapore.
Ophthalmology. 1999 Feb;106(2):223-31. doi: 10.1016/S0161-6420(99)90060-X.
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.
Randomized, masked, and partially controlled trial.
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.
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.
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.
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.
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.
评估含60微克地塞米松的Surodex药物递送系统（奥库莱克斯制药公司，加利福尼亚州森尼韦尔市）用于白内障手术的安全性，并将其抗炎效果与传统的0.1%地塞米松滴眼液进行比较。
随机、双盲且部分对照试验。
对60例接受白内障囊外摘除联合人工晶状体植入术的亚洲患者的60只眼进行检查。其中，28例患者的28只眼作为对照眼。患者按年龄和是否患有糖尿病进行分层。
手术结束时，将Surodex植入32只眼的前房。这些眼术后4周每天滴4次安慰剂滴眼液。对照眼既未植入Surodex也未植入安慰剂，但术后4周每天滴4次传统的0.1%地塞米松滴眼液。
在裂隙灯下对前房细胞和房水闪辉进行临床分级。术后长达3个月，使用日本东京兴和株式会社生产的Kowa FM500激光房水闪辉仪客观评估前房闪辉。术后长达1年进行眼压测量以及角膜内皮镜面显微镜检查和形态学细胞分析。
临床裂隙灯评估显示，接受Surodex治疗的眼与接受地塞米松滴眼液治疗的眼在前房闪辉和细胞方面无差异。闪辉仪读数显示，与地塞米松滴眼液组相比，Surodex组在所有术后随访时的闪辉水平较低。Surodex组在术后第4、8、15和30天闪辉降低具有统计学意义。3个月时，Surodex组的闪辉降至术前水平，而地塞米松滴眼液组仍升高。地塞米松滴眼液组有5只眼需要增加类固醇药物剂量，被视为治疗失败，而Surodex组只有1只眼。地塞米松滴眼液组有1例患者术后发生开角型青光眼，伴有严重的视野缺损和视盘杯状凹陷，导致视力仅存手动视力。术后长达1年，植入Surodex的眼与接受地塞米松滴眼液治疗的眼在内皮细胞损失方面无显著差异。
单次眼内植入Surodex是一种安全有效的治疗方法，可减轻白内障手术后的眼内炎症。通过临床方法测量，Surodex与0.1%地塞米松滴眼液在减轻眼内炎症方面疗效无统计学差异，而在用激光房水闪辉仪客观评估时，Surodex在减轻房水闪辉方面明显优于滴眼液。
