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
Evaluation of the efficacy and safety of phacoemulsification under the IOL protection:a randomized controlled clinical study
金玉娇 1李楠 1孙秋爽 1金韦奕 1江美玲 1刘颖锋 1卢焱 1孙丽霞 1崔仁哲1
作者信息
- 1. 延边大学附属医院眼科,延吉 133000
- 折叠
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.
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 gradeⅣ 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)/mm2and(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.
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Key words
Cataract/Lens,intraocular/Phacoemulsification/Corneal endothelium/Surgically induced astigmatism引用本文复制引用
基金项目
国家自然科学基金(82260205)
国家自然科学基金(81760171)
吉林省教育厅科技项目(十三五)(JJKH20191117KJ)
中国博士后科学基金面上项目(第六十五批)(206135)
出版年
2024
NETL
NSTL
万方数据