双眼植入Tecnis多焦点和单焦点球面人工晶状体的临床比较研究

目的 比较双眼植入Tecnis多焦点人工晶状体(IOL)与传统球面单焦点IOL对视觉功能的影响.方法 前瞻性临床研究.对100例(200只眼)患者实施超声乳化白内障吸除联合IOL植入术,采用随机数字表法随机植入前表面非球面和后表面衍射环的多焦点IOL(美国AMO公司Tecnis ZM900型;多焦点非球面组)与传统球面单焦点IOL(美国Bausch&Lomb公司Akreos Adapt型;单焦点球面组).随访3个月,检测两组IOL眼的5 m、1 m、63 cm、40 cm和30 cm各距离的裸眼视力和最佳远视力矫正下的近视力、调节幅度、全眼球差、对比敏感度、眩光敏感度以及近立体视锐度,并进行患者视功能和满意度问卷调查.对计量资料中两组数据进行正态性检验分析,满足正态分布的行t检验,不满足的行Mann-Whitney U检验,对计数资料行x2检验.结果 随访3个月后观察发现,30 cm和40cm距离多焦点非球面组的双眼远视力矫正下视力(logMAR视力)为0.24±0.12和0.22±0.11,明显优于单焦点球面组(Z=-8.261,P=0.000;Z=-5.508,P=0.000),其余各距离无明显差异;较之单焦点球面组,多焦点非球面组患者提高2.3～2.8 D的调节幅度(单眼Z=-10.655,P=0.000;双眼Z=-2.709,P=0.007);无论5 mm或3 mm瞳孔直径时多焦点非球面组的全眼球差[(0.027±0.160)μm,(0.006±0.083)μm]均小于单焦点球面组[(0.269±0.161)μm,(0.037±0.205)μm](Z=-8.815,P=0.000,Z=-2.791,P=0.005);两组的对比敏感度无明显差别,但单焦点球面组的眩光敏感度明显高于多焦点非球面组(P=0.0000);多焦点非球面组的裸眼近立体视锐度为(72.4±29.9)",优于单焦点球面组的(92.8±35.7)"(Z=-3.089,P=0.0002),近矫后近立体视锐度两组无统计学差异.结论 Tecnis多焦点非球面IOL较单焦点球面IOL可提供较好的近视力及调节幅度,提高近立体视锐度,非球面设计减少全眼球差,在一定程度上改善对比敏感度.

Binocular clinical comparison study of Tecnis multifocal aspheric and monofocal spherical intraocular lenses

Purpose To compare visual function in pseudophakic patients with bilateral implantation of Tecnis multifocal aspheric and conventional monofocal spherical intraocular lenses (IOL). Methods A prospective study of 100 consecutive cases (200 eyes) was conducted. All cataract patients underwent phaocoemulsification were randomized to receive multifocal aspheric IOL ( Tecnis ZM900, AMO, multifocal aspheric group) or conventional spherical IOL ( Akreos Adapt, Bausch&Lomb, monofocal spherical group) . The following investigations were performed to assess the uncorrected and distance-corrected visual acuity of distance, intermediate and near distances, accommodative amplitude, spherical aberrations of total eye, contrast sensitivity, glare sensitivity and near stereoacuity. Patients were surveyed for visual disturbances and lifestyle visual quality. The independent-samples t test waa used to compare the measure data which met normal distribution and the Mann-Whitney U test was used to compare the measure data which didn' t meet. The chi-square test was applied to compare categorical variables. Results The uncorrected and distance-corrected bilateral visual acuity of multifocal aspheric group at 30 cm and 40 cm were 0. 24 ± 0. 12 and 0. 22 ± 0. 11 (logMAR) , better than monofocal spherical group ( Z = - 8. 261, P = 0. 000;Z = -5. 508, P =0.000), but the visual acuity at other distances had no statistical difference between two groups. Patients with multifocal aspheric IOL had significantly higher accommodative amplitude than those with monofcal spherical IOL, improved about 2. 3 - 2. 8 D ( Z= -10. 655, P = 0. 000; Z =- 2. 709, P = 0. 007). Mean spherical aberration of multifocal aspheric group was ( 0. 027 ±0. 160) μm and (0. 006 ±0. 083)μm, significantly lower than that of monofocal spherical group (0. 269 ±0. 161) μm, (0.037 ±0.205) μm at 5 mm and 3 mm pupil diameter(Z= - 8. 815, P = 0. 000; Z = -2. 791, P = 0. 005) . The difference of contrast sensitivity was not significant, but glare sensitivity was higher for monofocal spherical group than for multifocal aspheric group. Multifocal aspheric group showed statistically better uncorrected stereoacuity (72.4 ± 29. 9 ) " than monofocal spherical group (92. 8 ± 35. 7)" ( Z =-3. 089,P = 0.002) . Conclusions The present clinical results demonstrated that Tecnis multifocal aspheric group had better near visual acuity, accommodative amplitude and near stereoacuity as compared to conventional monofocal spherical group. The aspheric design reduced spherical aberration of total eye and improved contrast sensitivity in some way.