Objective: To compare visual quality and satisfaction after multifocal toric intraocular lens (Acrysof IQ Restor toric, ART) and monofocal toric intraocular lens implantation in patients. Methods: It was a prospective nonrandomized Phase Ⅲ clinical trial. Patients with age-related cataract and corneal astigmatism were enrolled and accepted phacoemulsification combined with implantation of intraocular lens (IOL) in Henan Provincial Eye Hospital during March 2013 to December 2014. Fifty-six cases were divided into two groups according to which IOL they chose. ART group included 28 cases (3l eyes) aged from 41.0 to 72.0 years, with an average age of 61.5 years; toric group included 28 cases (33 eyes) aged from 42.0 to 75.0 years, with an average age of 63.5 years. Three months postoperatively, uncorrected distance visual acuity (UDVA) at 5, 70, 40 cm, corrected distance, intermediate, and near visual acuities, defocus curve, residual refractive astigmatism, rotational stability of the IOL, contrast sensitivity and patientsatisfaction were evaluated. All data were processed by statistic package deal SPSS 16.0. Postoperative visual acuity, residual astigmatism, IOL axial rotation and contrast sensitivity were compared by independent samples t test; preoperative and postoperative corneal astigmatism were compared by paired t-test; spectacle independency and halo incidence were processed by χ(2) test; visual satisfaction score was analyzed by Mann-Whitney test. Results: At 3 months postoperatively, in ART group, UDVA was (0.04±0.05), UIVA was (0.24±0.15), UNVA was (0.20±0.24). While in Toric group, UDVA was (0.06±0.04), UIVA was (0.30±0.13), UNVA was (0.47±0.21). There was no significant difference in UDVA between two groups(t=0.79, P=0.433). But in ART group, UIVA and UNVA were markedly better than those in Toric group(t=2.74, P=0.008; t=3.45, P<0.01). Depth of focus was 5.50 D (+2.00--3.50 D) in the ART group and 2.50 D (+1.00--1.50 D) in the Toric group. Average postoperative residual astigmatism was (-0.45±0.41)D in ART group and (-0.41±0.32)D in the Toric group. There was no significant difference between two groups (t=1.05, P=0.304). Average IOL rotation test was (2.95°±1.34°) in the ART group and (2.75°±1.64°) in the Toric group. There was no significant difference between two groups (t=0.67, P=0.452). Spectacle independency was achieved by 85.7% of patients in the ART group and 32.1% in the Toric group. There was no signifcant difference in distant visual satisfaction scores between the two groups(Z=0.71, P>0.05), while the intermediate and near visual satisfaction scores were significantly different(Z=2.27, P<0.05; Z=2.60, P<0.05) Conclusions: Both of the ART IOL and toric IOL can correct patients astigmatism. Implantation of ART IOL in patients with cataract and corneal astigmatism provided excellent distance, intermediate, and near visual outcomes. It provided better predictability of the refractive results, nice rotational stability, and good optical performance. At the same time, it improved the spectacle independency of cataract patients with astigmatism. (Chin J Ophthalmol, 2017, 53: 274-280).
目的: 比较Acrysof IQ Restor toric(ART)散光矫正型多焦点IOL和Acrysof IQ toric(Toric)单焦点IOL植入后患者的视功能状态和满意度。 方法: 前瞻性非随机对照Ⅲ期临床试验。选取2013年3月至2014年12月,在河南省立眼科医院行超声乳化白内障吸除联合IOL植入术的合并散光的年龄相关性白内障患者56例(64只眼),按患者自愿选择植入单焦点或多焦点IOL的原则分为2组,ART组28例(3l只眼),年龄41.0~72.0岁,平均61.5岁。Toric组28例(33只眼),年龄42.0~75.0岁,平均63.5岁。术后随访3个月,主要观察指标包括裸眼远(5 m)、中(70 cm)、近(40 cm)视力,最佳矫正远、中、近视力,离焦曲线,残余屈光度数,晶状体旋转度,对比敏感度及患者满意度。应用SPSS 16.0软件包处理数据,对患者术后视力、术后残余散光度、IOL轴向旋转度及对比敏感度进行独立样本t检验,患者术前与术后角膜散光度数进行配对设计t检验,患者术后脱镜率及光晕发生率进行χ(2)检验,视力满意度评分进行秩和检验。 结果: 两组患者术前各参数差异均无统计学意义。术后3个月ART组患者平均裸眼远视力0.04±0.05,平均裸眼中视力0.24±0.15,平均裸眼近视力0.20±0.24;Toric组患者平均裸眼远视力0.06±0.04,平均裸眼中视力0.30±0.13,平均裸眼近视力0.47±0.21,两组患者裸眼远视力差异无统计学意义(t=0.79,P=0.433),而裸眼中视力和近视力ART组优于Toric组(t=2.74,P=0.008;t=3.45,P<0.01),试验组焦点深度范围5.50 D(+2.00~-3.50 D),对照组为2.50 D(1.00~-1.50 D)。试验组术后平均残余散光度数(-0.45±0.41)D,对照组术后平均残余散光度数(-0.41±0.32)D,两组术后平均残余散光度差异无统计学意义(t=1.05,P=0.304)。术后3个月ART组IOL平均旋转2.95°±1.34°,Toric组IOL平均旋转2.75°±1.64°,两组之间差异无统计学意义(t=0.67,P=0.452)。ART组术后脱镜率达到85.7%,Toric组为32.1%。视远满意度评分两组间差异无统计学意义(Z=0.71,P>0.05),而视中和视近满意度评分差异有统计学意义(Z=2.27,P<0.05;Z=2.60,P<0.05)。 结论: ToricIOL和ART IOL均能较好地矫正散光,而且ART IOL可为合并角膜散光的白内障患者提供良好的远、中、近视力,残余屈光度预测性好,晶状体旋转稳定性和光学性能较好,提高了合并散光白内障患者的脱镜率和满意度。(中华眼科杂志,2017,53:274-280).
Keywords: Astigmatism; Lenses, intraocular; Phacoemulsification; Visual acuity.