Thomas B C, Auffarth G U, Philips R, Novák J, Blazek J, Adamkova H, Rabsilber T M
International Vision Correction Research Centre (IVCRC), Univ.-Augenklinik Heidelberg, Im Neuenheimer Feld 400, 69120, Heidelberg, Deutschland.
Ophthalmologe. 2013 Nov;110(11):1058-62. doi: 10.1007/s00347-013-2810-5.
The aim of the study was a clinical evaluation of an intraocular lens (IOL) with a segmental multifocal optic design and near addition of + 3.0 D as part of a CE approval study.
In a multicenter study the LENTIS Mplus LS-312 MF IOL (Oculentis) was implanted in 134 eyes of 79 patients with a mean age of 68 ± 12 years. The multifocality is achieved by implementation of a distance part and a segmented near sector. Three months after surgery, uncorrected and best corrected distance visual acuity (UCDVA and BCDVA, respectively), near visual acuity (UCNVA and BCNVA, respectively), contrast vision and patient satisfaction (questionnaire) were evaluated.
The IOLs were implanted uneventfully either unilaterally or bilaterally and 3 months postoperatively (n = 86 eyes) the following mean visual acuities were obtained (logMAR): UCDVA = 0.05, BCDVA = - 0.01, UCNVA = 0.09 and BCNVA = 0.02. Contrast sensitivity (n = 25 eyes) was within normal limits. Of the 66 questioned patients 10.6% spontaneously reported halos and 3% glare.
This new innovative multifocal IOL concept showed very good functional results as well as high patient satisfaction.
本研究旨在对一款具有分段多焦点光学设计且近附加度数为+3.0 D的人工晶状体(IOL)进行临床评估,这是一项CE认证研究的一部分。
在一项多中心研究中,将LENTIS Mplus LS - 312 MF人工晶状体(Oculentis)植入79例平均年龄为68±12岁患者的134只眼中。通过设置远用部分和分段式近用区域实现多焦点功能。术后三个月,评估未矫正和最佳矫正远视力(分别为UCDVA和BCDVA)、近视力(分别为UCNVA和BCNVA)、对比敏感度以及患者满意度(问卷调查)。
人工晶状体单侧或双侧植入均顺利,术后三个月(n = 86只眼)获得以下平均视力(logMAR):UCDVA = 0.05,BCDVA = -0.01,UCNVA = 0.09,BCNVA = 0.02。对比敏感度(n = 25只眼)在正常范围内。在66例接受询问的患者中,10.6%自发报告有光晕,3%报告有眩光。
这种新型创新的多焦点人工晶状体概念显示出非常好的功能效果以及较高的患者满意度。