囊袋内软壳技术在硬核白内障超声乳化术中的应用效果及安全性

Clinical outcomes and safety of intra-capsular bag soft-shell technique during phacoemulsification for hardnuclear cataract

背景硬核白内障行超声乳化手术易导致角膜水肿和后囊膜破裂，研究证实软壳技术在白内障行超声乳化摘出术中能有效减轻角膜水肿，但仍存在后囊膜破裂的风险。术中将软壳技术应用于囊袋内对晶状体后囊膜是否同样可以起保护作用，目前少有报道。目的观察囊袋内软壳技术在硬核白内障超声乳化术中的应用效果。方法采用前瞻性队列研究方法，纳入2013年11月至2015年5月在郑州大学第二附属医院眼科就诊的按Emery核硬度分级为Ⅳ～V级的年龄相关性白内障患者160例168眼。本研究经郑州大学第二附属医院伦理委员会批准。采用区组随机化方法，将患眼分为囊袋内软壳技术组78例80眼和常规软壳技术组82例88眼，前者术中应用囊袋内软壳技术实施3．0mm切口超声乳化术，后者术中应用常规软壳技术，2个组基线特征匹配。记录2个组术中超声乳化累计释放能量（CDE）及手术时间，观察后囊膜是否完整。分别于术后1d、1周和1个月在裂隙灯显微镜下观察和比较2个组术眼术后角膜水肿和前房炎症反应，采用TOPCON角膜内皮镜测定术眼角膜内皮细胞密度，测定术眼BCVA及眼压变化。结果囊袋内软壳技术组术眼CDE和手术时间分别为（20．13±8．34）％和（14．28±2．17）min，常规软壳技术组分别为（19．67±5．24）％和（15．36±3．49）min，组间差异均无统计学意义（t=0．216，P=0．376；扭0．403，P=0．518）。术中后囊膜破裂者囊袋内软壳技术组1眼，常规软壳技术组7眼。囊袋内软壳技术组术眼术后1d、1周和1个月BCVA≥0．5者分别占78％、83％和92％，常规软壳技术组分别为56％、71％和89％，囊袋内软壳技术组在术后1d和1周BCVA明显增加，差异均有统计学意义（x2=5．130，P=0．027；x2=4．361，P=0．032）。囊袋内软壳技术组和常规软壳技术组术眼术后3个月角膜内皮细胞丢失率分别为6．97％和7．19％，差异无统计学意义（P〉O．05）。2个组间在术前和术后1周眼压值的差异均无统计学意义（均P〉0．05），但囊袋内软壳技术组术后1d的眼压值为（20．16±4．23）mmHg（1mmHg=0．133kPa），明显高于常规软壳技术组的（17．38±5．21）mmHg，差异有统计学意义（t=1．241，P=0．037）。结论在硬核白内障超声乳化术中，应用囊袋内软壳技术的术眼术中及术后并发症的发生率较常规软壳技术低，术后视力恢复更快。

Background Phacoemulsification for hard nuclear cataract is easy to cause corneal edema and posterior capsular rupture. Researches determined that soft-shell technique phacoemulsifieation can effectively reduce corneal edema,but the risk of posterior capsular rupture during the surgery is still existed. Whether intra-capsular bag soft-shell technique can protect the posterior capsular of lens from rupture is still unclear. Objective This study was to observe the effect of intra-capsular bag soft-shell technique phacoemulsification on hard nuclear cataract. Methods A prospective cohort study was designed. One hundred and sixty-eight eyes of 160 patients with age-related cataract and 1V-V grade of nucleus were enrolled in Affiliated Second Hospital of Zhengzhou University from November 2013 to May 2015 under the approval of Ethic Commission and informed consent of the patients. The eyes were randomized into the intra-capsular soft-shell technique group and conventional soft-shell technique group with the matched age,gender and nuclear hardness in a manner of randomized block design. A 3.0 mm incision of cataract phacoemulsification with soft-shell technique in capsular bag was performed on 80 eyes of 78 patients in the intra- capsular soft-shell technique group, and conventional soft-shell technique phacoemulsification was performed on 88 eyes of 82 patients in the conventional soft-shell technique group. Intraoperative records including the cumulative dissipated energy,effective phacoemulsification time and posterior capsular changes were recorded during the surgery.Postoperative follow-up indexes included corneal edema, endothelial cell density, BCVA and intraocular pressure changes. Results The mean cumulative dissipated energy and operation duration were （20. 13± 8.34）% and （14.28±2.17） minutes in the intra-capsular soft-shell technique group, and those in the conventional soft-shell technique group were （19.67±5.24） % and （ 15.36 ± 3.49 ） minutes, showing significant differences between them （ t = 0.216, P = 0. 376 ; t = 0. 403, P = 0. 518 ）. Posterior capsular rupture occurred in 1 eye in the intra-capsular soft- shell technique group and 7 eyes in the conventional soft-shell technique group. The percentages of eyes with BCVA〉 0.5 were 78% ,83% and 92% in postoperative 1 day,1 week and 1 month in the intra-capsular soft-shell technique group,and those in the conventional soft-shell technique group were 56% ,71% and 89% ,with a significant increase in postoperative 1 day, 1 week in the intra-capsular soft-shell technique group （X2 = 5. 130, P = 0. 027 ;X2 = 4. 361, P =0. 032）. The corneal endothelial cell loss rates were 6.97% and 7.19% in the intra-capsular soft-shell technique group and conventional soft-shell technique group respectively in postoperative 3 months,with no significant difference between them （P〉0.05）. The intraocular pressure was （20.16±4.23） mmHg （1 mmHg= 0.133 kPa） in postoperative 1 day in the intra-capsular soft-shell technique group, which was significantly higher than （17.38± 5.21 ） mmHg in the conventional soft-shell technique group （ t = 1. 241, P = 0. 037 ）. Conclusions Intra-capsular bag soft-shell technique phacoemulsification for hard nuclear cataract can decrease the intraoperative and postoperative complications and quicken the visual recovery after surgery.