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比较双轴微切口与同轴小切口用于白内障手术的对照临床试验。

Controlled clinical trial comparing biaxial microincision with coaxial small incision for cataract surgery.

作者信息

Dick H Burkhard

机构信息

Institute of Vision Science, Ruhr University, Bochum, Germany.

出版信息

Eur J Ophthalmol. 2012 Sep-Oct;22(5):739-50. doi: 10.5301/ejo.5000100.

Abstract

PURPOSE

Clinical outcomes of biaxial microincision versus coaxial small incision cataract surgery were compared in a prospective, controlled, paired-eye clinical study.

METHODS

A total of 84 eyes of 42 patients underwent cataract surgery using the biaxial microincision (B-MICS) technique in either the right or left eye. The fellow eye was to undergo cataract surgery using the standard coaxial small incision (SICS) technique. All surgeries were performed using the Stellaris Vision Enhancement System and all eyes were implanted with an aspheric microincision intraocular lens (IOL). The 1.2-mm B-MICS incision was widened to 1.8 mm for IOL insertion. The main outcome measure was the change from baseline best-corrected visual acuity (BCVA). Secondary outcome measures were uncorrected visual acuity (UCVA), surgically induced astigmatism (SIA), manifest subjective refraction in spherical equivalent (MRSE), absolute phacoemulsification time (APT), effective phacoemulsification time (EPT), mean phacoemulsification power, and endothelial cell count (ECC). Follow-up was at 1 day, 3 days, 1 week, and 2 months.

RESULTS

The treatment groups did not differ in baseline characteristics. Improvement in BCVA over baseline logarithm of the minimum angle of resolution (logMAR) was statistically significantly greater with B-MICS than SICS at 1 day (B-MICS -0.1, SICS -0.05; 95% CI -0.26 to -0.05, p=0.005). Mean improvement in UCVA from baseline was greater with B-MICS at 1 day (B-MICS -0.33, SICS -0.12; 95% CI -0.35 to -0.10, p=0.001), 3 days (B-MICS -0.39, SICS -0.26; 95% CI -0.22 to -0.02, p=0.022), 1 week (B-MICS -0.44, SICS -0.33; 95% CI -0.20 to -0.009, p=0.033), and 2 months (B-MICS -0.47, SICS 0.38; 95% CI -0.19 to +0.002, p =0.054). At 2 months, SIA was significantly lower with B-MICS than SICS (B-MICS 0.70 D, SICS 0.89 D; 95% CI -0.39 to -0.1, p=0.045), as was endothelial cell loss (B-MICS -1.4%, SICS -7.8%; p=0.05). The EPT was lower with B-MICS (B-MICS 1.60 s, SICS 2.80 s; 95% CI -1.68 to -0.77, p<0.001) with no difference in mean phaco power.

CONCLUSIONS

Compared to the standard small incision technique, B-MICS showed earlier improvement in BCVA, better overall UCVA, less SIA, and less endothelial cell loss.

摘要

目的

在一项前瞻性、对照、双眼配对的临床研究中,比较双轴微切口与同轴小切口白内障手术的临床效果。

方法

42例患者的84只眼,右眼或左眼采用双轴微切口(B-MICS)技术进行白内障手术。另一只眼采用标准同轴小切口(SICS)技术进行白内障手术。所有手术均使用Stellaris视觉增强系统,所有眼均植入非球面微切口人工晶状体(IOL)。1.2mm的B-MICS切口在植入IOL时扩大至1.8mm。主要观察指标是最佳矫正视力(BCVA)相对于基线的变化。次要观察指标包括裸眼视力(UCVA)、手术源性散光(SIA)、等效球镜的显主观验光(MRSE)、绝对超声乳化时间(APT)、有效超声乳化时间(EPT)、平均超声乳化功率和内皮细胞计数(ECC)。随访时间为术后1天、3天、1周和2个月。

结果

治疗组的基线特征无差异。术后1天,B-MICS组BCVA相对于基线最小分辨角对数(logMAR)的改善在统计学上显著大于SICS组(B-MICS -0.1,SICS -0.05;95%可信区间 -0.26至 -0.05,p = 0.005)。术后1天(B-MICS -0.33,SICS -0.12;95%可信区间 -

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