Nováček Ladislav Viktor, Němcová Marie, Tyx Kateřina, Lahodová Kristýna, Rejmont Leoš, Rozsíval Pavel, Studený Pavel
Department of Ophthalmology, Institute of Aviation Medicine Prague, Prague, Czechia.
Department of Ophthalmology, 1st Faculty of Medicine, Charles University and the Military University Hospital Prague, Prague, Czechia.
Biomed Hub. 2021 Feb 17;6(1):30-41. doi: 10.1159/000513894. eCollection 2021 Jan-Apr.
The aim of this study was to assess the clinical outcomes, predictability of results, efficiency of astigmatism correction, and rotational stability of the Bi-Flex 677TAY (Medicontur Medical Engineering Ltd., Zsámbék, Hungary) monofocal toric intraocular lens (IOL) designed for cataract patients with astigmatism.
The IOLs were implanted either mono- or binocularly, following routine cataract surgery. Visual and refractive outcomes, as well as off-axis rotation were assessed throughout a 1-year follow-up period. All clinical data for this work were collected retrospectively. Vector analysis based on the Alpins method was performed to assess the efficiency of astigmatism correction.
No complications or adverse events occurred during surgery or the follow-up period. IOL implantation brought 88% of eyes into the ±0.50 D, and 100% into the ± 1.00 D range compared to the target spherical equivalent refraction, emmetropia. Astigmatism correction brought similar results: 94% of eyes had a residual cylindrical error of not higher than ±0.50 D, and 97% were within ±1.00 D. Vector analysis resulted in a correction index of 0.96 and a difference vector of 0.17. Both refractive and visual outcomes showed long-term stability. During the 12-month follow-up period, no eyes had a rotation of >5°. Absolute rotation after 1 year was 1.42 ± 1.89° (median = 0°), while signed rotation was 1.06 ± 2.12° (median = 0°).
The Bi-Flex 677TAY monofocal toric IOL, designed by Medicontur Medical Engineering Ltd., represents an efficient and safe solution for cataract patients with astigmatism. Clinical and refractive outcomes are predictable, and rotational stability ensures long-term visual comfort.
本研究旨在评估专为有散光的白内障患者设计的Bi-Flex 677TAY(匈牙利Zsámbék的Medicontur Medical Engineering Ltd.)单焦点散光人工晶状体(IOL)的临床结果、结果的可预测性、散光矫正效率和旋转稳定性。
在常规白内障手术后,单眼或双眼植入IOL。在整个1年的随访期内评估视觉和屈光结果以及离轴旋转情况。这项工作的所有临床数据均为回顾性收集。基于阿尔平斯方法进行矢量分析以评估散光矫正效率。
手术期间或随访期内未发生并发症或不良事件。与目标球镜等效屈光度(正视)相比,IOL植入使88%的眼睛达到±0.50 D范围,100%的眼睛达到±1.00 D范围。散光矫正也得到了类似结果:94%的眼睛残余柱镜误差不高于±0.50 D,97%的眼睛在±1.00 D范围内。矢量分析得出矫正指数为0.96,差异矢量为0.17。屈光和视觉结果均显示出长期稳定性。在12个月的随访期内,没有眼睛的旋转度数>5°。1年后的绝对旋转度数为1.42±1.89°(中位数=0°),有符号旋转度数为1.06±2.12°(中位数=0°)。
由Medicontur Medical Engineering Ltd.设计的Bi-Flex 677TAY单焦点散光IOL,为有散光的白内障患者提供了一种有效且安全的解决方案。临床和屈光结果是可预测的,旋转稳定性确保了长期的视觉舒适度。