非对称区域折射型多焦点人工晶状体植入术后中期临床效果的研究

Mid-term clinical observation of SBL-3 asymmetric segmented multifocal intraocular lens

目的探讨SBL-3新型区域折射型多焦点人工晶状体(MIOL)植入术后的中期临床效果。方法前瞻性研究。选取2016年6月至2018年1月在成都爱尔眼科医院诊断为年龄相关性白内障,并行超声乳化白内障吸除联合人工晶状体植入的患者59例(87只眼)为研究对象。根据植入人工晶状体类型的不同分为两组。其中,30例(40只眼)植入SBL-3新型区域折射多焦点人工晶状体为多焦组; 29例(47只眼)植入Softec HD单焦点人工晶状体为单焦组。术后随访3～12个月,记录术后裸眼远距离(5 m)、中距离(80 cm)、近距离(40 cm)的裸眼视力,矫正远视力及术后等效球镜屈光度;利用VF-14量表行主观问卷调查;对术后眩光的发生率、日常生活老视眼镜依赖与否进行问卷记录;采用双通道视觉质量分析系统测量客观散射指数(OSI)、调制传递函数截止空间频率(MTF cutoff)、斯特尔比值(SR)、对比度视力(包含100%、20%及9%三种)及调节幅度等指标。单焦组和多焦组两组患者各个指标的比较采用独立样本t检验,术前术后的比较采用配对t检验。结果单焦组与多焦组患者术后裸眼远距离视力均较术前有显著提高,差异有统计学意义(t=-10. 859,-13. 382; P <0. 05)。多焦组与单焦组术后等效球镜屈光度差异无统计学意义(t=1. 370,P> 0. 05)。多焦组与单焦组患者术后裸眼远距离视力分别为(0. 87±0. 17)与(0. 82±0. 21),差异无统计学意义(t=-1. 129,P> 0. 05)。多焦组与单焦组患者术后矫正远距离视力分别为(0. 91±0. 13)与(0. 91±0. 14),差异无统计学意义(t=0. 081,P> 0. 05)。多焦组与单焦组患者术后裸眼中距离视力分别为(0. 70±0. 17)与(0. 54±0. 22),差异具有统计学意义(t=-3. 888,P <0. 05)。多焦组与单焦组患者术后裸眼近距离视力分别为(0. 71±0. 20)与(0. 28±0. 10),差异具有统计学意义(t=-12. 340,P <0. 05)。单焦组与多焦点组患者采用VF-14表评分分别为(75. 39±10. 30)与(97. 50±4. 50),前者低于后者,差异有统计学意义(t=-9. 837,P <0. 05)。多焦组与单焦组患者对老视眼镜的依赖程度分别为5%(2/40)与93. 6%(44/47),差异有统计学意义(χ~2=68. 104,P <0. 05)。多焦组与单焦组患者术后眩光的发生率分别为7. 5%(3/40)与4. 26%(2/47),差异无统计学意义(χ~2=0. 035,P> 0. 05)。多焦组与单焦组患者的MTF cutoff分别为(24. 17±7. 68) c/deg与(27. 00±10. 98) c/deg,差异无统计学意义(t=1. 398,P> 0. 05)。多焦组与单焦组患者的OSI分别为(2. 0±0. 7)与(1. 7±0. 8),差异无有统计学意义(t=-2. 139,P> 0. 05)。多焦组与单焦组患者的SR分别为(0. 13±0. 03)与(0. 15±0. 06),差异有统计学意义(t=2. 130,P <0. 05)。多焦组与单焦组患者在100%、20%及9%对比度视力比较,差异均无统计学意义(t=1. 545,1. 886,1. 968; P> 0. 05)。多焦组与单焦组患者术眼调节幅度分别为(2. 30±0. 80) D与(1. 60±0. 70) D,差异有统计学意义(t=-3. 600,P <0. 05)。结论SBL-3新型区域折射多焦点人工晶状体可以提供较好的全程视力和视觉质量,术后患者满意度较高。

Objective The aim of this study was to study the mid-term clinical outcomes of SBL-3 asymmetric segmented multifocal intraocular lens.Methods Prospective study.59 subjects(87 eyes)in AIER Eye Hospital(Chengdu)diagnosed with aged related cataract from Jun 2016 to Jan 2018 were enrolled in this study.All subjects were follow-up from 3 to 12 months postoperatively.They were divided into two groups according to the type of intraocular lens implanted.Multi-focal group:30 subjects(40 eyes)were implanted with SBL-3 Mf-IOL.Monofocal group:29 subjects(47 eyes)were implanted with mono-focal IOL(Softec HD).The uncorrected distance VA(5 meters),intermediate VA(80 cm),near VA and spherical equivalent were measured at each visit.Visual function was evaluated by using the VF-14-CN questionnaire.Double-pass visual quality analysis system was used to evaluated the visual quality,including the Objective Scatter Index(OSI),Modulation transfer function cut off(MTF cutoff),strehl ratio(SR),contrast sensitive at 100%,20%,9%respectively and the pseudo-accommodation.Independent sample t test was used to compare the indices of patients in monofocal group and multifocal group,and paired t test was used to compare the indices before and after operation.Results Distance VA of all subjects were improved dramatically after surgery(t=-13.382,-10.859;P<0.05).No significant statistical difference was found between multi-focal group and mono-focal group in spherical equivalent(t=1.370,P>0.05).Uncorrected distance VA in multi-focal group was(0.87±0.17)and in mono-focal group was(0.82±0.21),Corrected distance VA in multi-focal group was(0.91±0.13)and in mono-focal group was(0.91±0.14),but there were no statistical differences between two groups(t=-1.129,0.081;P>0.05).Intermediate VA:Multi-focal group was(0.70±0.17),mono-focal group was(0.54±0.22),multi-focal group was better than mono-focal group(t=-3.888,P<0.05).Near VA:multi-focal group was(0.71±0.20),mono-focal group was(0.28±0.10),multi-focal group was better than mono-focal group(t=-12.340,P<0.05).In terms of VF-14 scale score,the former group(75.39±10.30)was significantly lower than the later group(97.50±4.50),and the difference was statistically significant(t=-9.837,P<0.05).As for reading glasses,44 of 47 subjects(93.6%)need reading glasses for near vision in the monofocal group,but only 2 of 40(5%)need reading glasses in the multi-focal group.The difference was also statistically significant(χ^2=68.104,P<0.05).As for glare,2 of 47 subjects(4.26%)of mono-focal group was reported glare compared to the multi-focal group(3 of 40 subjects).No statistical significance was found(χ^2=0.035,P>0.05).MTF cutoff in mono-focal group(27.00±10.98)c/deg was better than in multi-focal group(24.17±7.68),but no significant statistical differences were found between two groups(t=1.398,P>0.05).OSI in mono-focal group(1.7±0.8)was better than in multi-focal group(2.0±0.7),but no significant statistical differences were found between two groups(t=-2.139,P>0.05).Significant statistical differences were found between two groups in SR(0.13±0.03),mono-focal group was(0.15±0.06),(t=2.130,P<0.05).The contrast sensitivity vision of mono-focal group was better than multi-focal at 100%,20%and 9%contrast,but still no statistical difference was found.(t=1.545,1.886,1.968;P>0.05).In terms of pseudo-accommodation,multi-focal group(2.30±0.80)D was much higher than mono-focal group(1.60±0.70)D.(t=-3.600,P<0.05).Conclusions Compared to the traditional mono-focal IOL,the novel SBL-3 asymmetric segmented multifocal intraocular lens can provide better full range of clear vision and visual quality,which may help to achieve good patient postoperative satisfaction.