Uthoff Detlef, Gulati Amit, Hepper Daniel, Holland Detlef
Eye Hospital Bellevue, Kiel, Germany.
J Refract Surg. 2007 Feb;23(2):159-71. doi: 10.3928/1081-597X-20070201-08.
To investigate the advantages, clinical outcomes, and safety after implantation of the 1CU (HumanOptics AG) optic shift intraocular lens (IOL) in comparison with a conventional monofocal IOL.
In a prospective non-randomized study, 553 eyes implanted with the 1CU IOL were examined. In a control group, a monofocal posterior chamber IOL (MCTE, Dr Schmidt) was implanted in 219 eyes. Follow-up was performed at 1, 6, and 12 months postoperatively. The clinical effect for near visual acuity was evaluated by subjective measurements using an accommodometer, defocusing curve, and Nieden charts.
No significant differences were noted in distance best spectacle-corrected visual acuity (BSCVA) between groups. Average near visual acuity with distance BSCVA for the 1CU was 0.41 and 0.35 for the control group. The difference in the accommodation response between both groups measured with the accommodometer was 11 cm (P < .01). The refraction tolerance for the 1CU was 0.25 D whereas the MCTE revealed no refraction tolerance (P < .01). Decentration and tilting of the 1CU resulted in explantation of three IOLs.
The 1CU indicates a minor statistical advantage of half a reading step towards monofocal IOLs measured with subjective methods in near point, defocusing curve, and near visual acuity with distance BSCVA. This could be due to pseudophakic accommodation by the optic shift mechanism or a result of additional pseudophakic pseudoaccommodation. The accommodative effect of the 1CU differed from patient to patient and was not predictable.
比较植入1CU(德国HumanOptics AG公司)光学移位人工晶状体(IOL)与传统单焦点IOL后的优势、临床效果及安全性。
在一项前瞻性非随机研究中,对553只植入1CU IOL的眼睛进行了检查。在对照组中,219只眼睛植入了单焦点后房型IOL(德国施密特博士公司的MCTE)。术后1、6和12个月进行随访。使用调节计、散焦曲线和尼登图表通过主观测量评估近视力的临床效果。
两组间远距离最佳矫正视力(BSCVA)无显著差异。1CU组远距离BSCVA对应的平均近视力为0.41,对照组为0.35。用调节计测量的两组间调节反应差异为11 cm(P <.01)。1CU的屈光耐受性为0.25 D,而MCTE无屈光耐受性(P <.01)。1CU的偏心和倾斜导致3只IOL被取出。
1CU在近点、散焦曲线以及远距离BSCVA对应的近视力方面,通过主观方法测量显示出比单焦点IOL有半个阅读级别的微小统计学优势。这可能是由于光学移位机制导致的人工晶状体调节,或者是额外的人工晶状体假性调节的结果。1CU的调节效果因人而异,无法预测。