Miháltz Kata, Vécsei-Marlovits Pia Veronika
Department of Ophthalmology, Hospital Hietzing, Wolkersbergenstrasse 1, 1130, Vienna, Austria.
Karl Landsteiner Institute of Process Optimization and QM in Cataract Surgery, Vienna, Austria.
Graefes Arch Clin Exp Ophthalmol. 2021 Mar;259(3):673-683. doi: 10.1007/s00417-020-05052-5. Epub 2021 Jan 20.
To evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL.
In this prospective, randomized comparative study, 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration-correcting diffractive, bifocal Tecnis ZLB00 IOL and 60 eyes of 30 age-matched subjects with the spherical aberration neutral, diffractive, bifocal Diffractiva IOL. Observation procedure was performed 1, 3, and 6 months postoperatively. Main outcome measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations, and visual quality metrics with 2 mm and 4 mm pupil and the position of visual axis.
At the 6-month visit, no significant difference was found in monocular and binocular uncorrected (UDVA) and corrected (CDVA) distance and near (UNVA, CNVA) visual acuity between the groups. Spherical and coma-like aberrations were similar measured with a 2-mm pupil, but with a 4-mm pupil, the SA was significantly larger (in negative direction) in the Diffractiva group. The higher-order Strehl ratio and MTF was significantly larger in the Diffractiva group measured at 2 mm entrance pupil; however, this difference disappeared by the 4-mm pupil measurements. Postoperative angle alpha distance had a significant influence on HO Strehl value.
The size of angle alpha is a predictive factor of image quality by multifocal IOL patients.
Trial registration number and date of registration: NCT04274088, 14.02.2020.
评估视轴定位对Tecnis多焦点人工晶状体（MIOL）和Diff-aA多焦点人工晶状体光学性能的影响。
在这项前瞻性、随机对照研究中，35例患有老年性白内障的受试者的70只眼植入了具有矫正球差功能的衍射型双焦点Tecnis ZLB00人工晶状体，30例年龄匹配的受试者的60只眼植入了球差为零的衍射型双焦点Diffractiva人工晶状体。术后1、3和6个月进行观察。主要观察指标包括未矫正和矫正的远、近视力、显验光、眼像差、2mm和4mm瞳孔下的视觉质量指标以及视轴位置。
在术后6个月的随访中，两组之间的单眼和双眼未矫正（UDVA）及矫正（CDVA）远、近视力（UNVA、CNVA）均无显著差异。2mm瞳孔下测量的球差和类彗差相似，但4mm瞳孔下，Diffractiva组的球差（负向）明显更大。Diffractiva组在2mm入瞳时测量的高阶斯特列尔比和调制传递函数明显更大；然而，在4mm瞳孔测量时，这种差异消失。术后角α距离对高阶斯特列尔值有显著影响。
角α的大小是多焦点人工晶状体患者图像质量的预测因素。
试验注册号和注册日期：NCT04274088，2020年2月14日。
