金玉娇; 李楠; 孙秋爽; 金韦奕; 江美玲; 刘颖锋; 卢焱; 孙丽霞; 崔仁哲

doi:10.3760/cma.j.cn115989-20221121-00542

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• 临床研究 •

人工晶状体保护下超声乳化白内障吸除术疗效及安全性评价：一项随机对照临床研究

中华实验眼科杂志, 2024,42(3) : 248-255. DOI: 10.3760/cma.j.cn115989-20221121-00542

摘要

目的

观察人工晶状体(IOL)保护下超声乳化手术(PHACO)对硬核白内障患者的治疗效果。

方法

采用随机对照临床研究方法，连续纳入2019年1月至2022年5月于延边大学附属医院收治的Emery分级Ⅳ～Ⅴ级的硬核白内障患者120例120眼，按照随机数字表法分为PHACO组、IOL保护PHACO组和囊外白内障摘除术(ECCE)组，分别行常规PHACO、IOL保护下的PHACO和ECCE，每组40例40眼。最终99例受试者完成随访，其中PHACO组30例30眼，IOL保护PHACO组35例35眼，ECCE组34例34眼。记录各组总手术时间、术中超声乳化时间、累计释放能量。术后随访3个月，检测并比较3个组患眼角膜内皮细胞密度(ECD)、角膜内皮细胞面积变异系数(CV)、角膜六角形内皮细胞比率(6A)、角膜散光值，不同等级裸眼远视力的眼数分布；记录术中和术后并发症发生情况。

结果

IOL保护PHACO组与PHACO组超声能量及超声时间比较差异均无统计学意义(P＝0.691、0.982)。IOL保护PHACO组和PHACO组总手术时间分别为(38.81±2.73)和(36.45±3.45)min，明显短于ECCE组的(69.60±4.35)min，差异均有统计学意义(均P<0.001)。术前3个组患者年龄、性别、晶状体核硬度等基本资料比较，差异均无统计学意义(均P>0.05)。术后3个月，PHACO组和IOL保护PHACO组裸眼视力较高的人数较ECCE组高(P＝0.006、0.007)；IOL保护PHACO组的ECD和6A分别为(2 155.57±177.88)/mm²和(41.31±5.18)%，均显著高于PHACO组的(1 912.64±224.11)/mm²和(36.18±3.27)%，IOL保护PHACO组的CV为(50.34±5.90)%，低于PHACO组的(55.67±3.30)%，差异均有统计学意义(P＝0.007、0.003、0.005)。术后1周和3个月，IOL保护PHACO组的角膜散光度数均显著低于ECCE组，且高于PHACO组，差异均有统计学意义(均P<0.05)。

结论

IOL保护下的PHACO相对常规PHACO可有效减少超声能量对角膜内皮的损伤，相对ECCE能明显缩短手术时间，减轻术后炎症反应，且并未明显增加术后角膜散光。IOL保护下的PHACO是硬核白内障患者一种有效的改良手术方式。

引用本文: 金玉娇, 李楠, 孙秋爽, 等. 人工晶状体保护下超声乳化白内障吸除术疗效及安全性评价：一项随机对照临床研究 [J] . 中华实验眼科杂志, 2024, 42(3) : 248-255. DOI: 10.3760/cma.j.cn115989-20221121-00542.

参考文献导出: Endnote NoteExpress RefWorks NoteFirst 医学文献王

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晶状体超声乳化术(phacoemulsification，PHACO)是治疗白内障的主流手术方式，其手术切口小，患者术后恢复快、效果好^[1]。PHACO的关键在于应用超声波的能量将晶状体核粉碎，然后与皮质一起吸除。在术中超声乳化能量是以乳化针头的斜面向外扇形辐射，超声能量对角膜内皮损伤是术后并发症的主要原因，尤其对于晶状体核硬度大的白内障患者，术中超声粉碎核需要更长的乳化时间和更多的能量，加重对角膜内皮的损伤，可能导致术后发生角膜内皮失代偿。角膜内皮细胞密度(endothelial cell density，ECD)<1 000/mm²是超声乳化术的相对禁忌证^[2,3,4]。对于硬核或低ECD的白内障患者，囊外白内障摘除术(extracapsular cataract extraction，ECCE)可避免过多的超声能量对角膜内皮造成损伤，但需制作较大的巩膜切口，术后较大的散光度数和较重的创伤反应往往会影响术后效果^[5]。研究者们尝试通过改变碎核方式来减少手术对角膜内皮的损伤^[6,7]，如原位碎核技术、切削翻转法、劈裂翻转法、改良拦截劈核法、高负压劈核技术、扭转爆裂式超声乳化术等，这些碎核方法都是结合超声能量和机械劈核以尽量减少超声能量，但超声能量的减少有限。因此，探索一种可以阻断超声能量与角膜内皮接触的改良方法具有重要的临床意义。本团队前期研究尝试先将人工晶状体(intraocular lens，IOL)植入前房，在IOL保护角膜内皮下再进行超声乳化，发现IOL可以起到隔离超声能量的作用，减轻了超声能量对角膜内皮的损伤，术后角膜内皮皱褶和角膜水肿的发生率低于常规的PHACO。为进一步系统分析该方法的可行性，本研究选择硬核白内障患者行IOL保护下PHACO，对比传统的白内障手术方式，观察手术效果及对角膜内皮的影响，以期为硬核白内障患者探索一种改良的手术方式。

贡献者信息

金玉娇

延边大学附属医院眼科，延吉　133000

李楠

延边大学附属医院眼科，延吉　133000

孙秋爽

延边大学附属医院眼科，延吉　133000

金韦奕

延边大学附属医院眼科，延吉　133000

江美玲

延边大学附属医院眼科，延吉　133000

刘颖锋

延边大学附属医院眼科，延吉　133000

卢焱

延边大学附属医院眼科，延吉　133000

孙丽霞

延边大学附属医院眼科，延吉　133000

崔仁哲

延边大学附属医院眼科，延吉　133000

通信作者

孙丽霞

延边大学附属医院眼科，延吉　133000

Email：sunlx_2008@163.com

崔仁哲

延边大学附属医院眼科，延吉　133000

Email：cuirenzhe@163.com

关键词

白内障; 人工晶状体; 超声乳化白内障吸除术; 角膜内皮; 术源性散光;

基金项目

国家自然科学基金（82260205、81760171）

吉林省教育厅"十三五"科学技术项目（JJKH20191117KJ）

第65批中国博士后科学基金面上资助项目（206135）

作者声明

金玉娇、李楠对本文有同等贡献

作者贡献声明

金玉娇、李楠：论文撰写、数据分析；孙秋、金韦奕：收集数据；江美玲、刘颖锋、卢焱：数据整理、查阅文献；孙丽霞：研究设计、论文指导与定稿；崔仁哲：研究实施及论文定稿

利益冲突

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历史

出版日期：2024-03-10

收稿日期：2023-11-10

修回日期：2024-02-24

本文编辑

张宇骆世平

Clinical Science

Evaluation of the efficacy and safety of phacoemulsification under the IOL protection: a randomized controlled clinical study

Jin Yujiao, Li Nan, Sun Qiushuang, Jin Weiyi, Jiang Meiling, Liu Yingfeng, Lu Yan, Sun Lixia, Cui Renzhe

Published 2024-03-10

Cite as Chin J Exp Ophthalmol, 2024, 42(3): 248-255. DOI: 10.3760/cma.j.cn115989-20221121-00542

Abstract

Objective

To observe the therapeutic effect of intraocular lens (IOL) protected phacoemulsification (PHACO) in patients with hard nucleus cataract.

Methods

A randomized controlled clinical study was conducted.A total of consecutive 120 patients (120 eyes) with hard nucleus cataract of Emery grade Ⅳ or Ⅴ were enrolled from January 2019 to May 2022.The patients were randomly divided into PHACO group receiving routine PHACO, IOL protected PHACO group receiving PHACO under IOL protection, and extracapsular cataract extraction (ECCE) group receiving ECCE, with 40 cases (40 eyes) in each group.Finally, 99 patients completed the follow-up, including 30 cases (30 eyes) in PHACO group, 35 cases (35 eyes) in IOL protected PHACO group, and 34 cases (34 eyes) in ECCE group.The total operation time, intraoperative PHACO time and cumulative energy release of each patient were recorded.The corneal endothelial cell density (ECD), coefficient of variation in endothelial cell area (CV), hexagonal endothelial cell ratio (6A), corneal astigmatism and the number of eyes with different grades of uncorrected visual acuity were measured and compared after 3-month follow-up.The intraoperative and postoperative complications were recorded.This study adhered to the Declaration of Helsinki and was approved by the Ethics Committee of Yanbian University Hospital (NO.2023002).Patients were informed of study content and purpose and signed a consent form before treatment.

Results

There was no significant difference in ultrasonic energy and time between PHACO group and IOL protected PHACO group (P=0.691, 0.982).The total operation time was (38.81±2.73) and (36.45±3.45) minutes in PHACO group and IOL protected PHACO group, significantly shorter than (69.60±4.35) minutes in ECCE group (both at P<0.001).There was no significant difference in age, sex, lens nucleus hardness and other baseline data among the three groups before operation (all at P>0.05).Three months after operation, the number of patients with higher uncorrected visual acuity in PHACO group and IOL protected PHACO group was larger than that in ECCE group (P=0.006, 0.007).The ECD and 6A in IOL protected PHACO group were (2 155.57±177.88)/mm² and (41.31±5.18)%, respectively, which were significantly higher than (1 912.64±224.11)/mm² and (36.18±3.27)% in PHACO group, and the CV in IOL protected PHACO group was (50.34±5.90)%, which was lower than (55.67±3.30)% in PHACO group, showing statistically significant differences (P=0.007, 0.003, 0.005).At 1 week and 3 months after the operation, the corneal astigmatism was significantly lower in IOL-protected PHACO group than in ECCE group, but higher than in PHACO group, and the difference were statistically significant (all at P<0.05).

Conclusions

Compared with conventional PHACO, IOL-protected PHACO can effectively reduce the damage of corneal endothelium caused by ultrasonic energy, shorten the operation time and reduce postoperative inflammatory reaction compared with ECCE, and does not significantly increase postoperative corneal astigmatism.IOL-protected PHACO is an effective improved surgical method for patients with hard nucleus cataract.

Key words:

Cataract; Lens, intraocular; Phacoemulsification; Corneal endothelium; Surgically induced astigmatism

Contributor Information

Jin Yujiao