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传统超声乳化白内障吸除术或飞秒激光辅助白内障手术后非球面疏水人工晶状体的囊袋性能:一项随机前瞻性研究的12个月结果

Capsular bag performance of an aspheric hydrophobic IOL after conventional phacoemulsification or femtosecond laser-assisted cataract surgery: 12-month results of a randomized prospective study.

作者信息

Casazza Marina, Reifeltshammer Sophia Anna, Hirnschall Nino, Wendelstein Jascha, Mariacher Siegfried, Laubichler Peter, Siska René, Bolz Matthias

机构信息

Department of Ophthalmology, Medical University Graz, Neue Stiftingtalstraße 6, Graz, 8010, Austria.

Department of Ophthalmology and Optometry, Kepler University Hospital, Linz, Austria.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2025 Jul 18. doi: 10.1007/s00417-025-06919-1.

Abstract

PURPOSE

To evaluate a new hydrophobic aspheric intraocular lens (IOL) regarding its refractive and position stability after conventional (CCS) or femtosecond laser-assisted cataract surgery (FLACS).

METHODS

All patients received the same IOL (CT LUCIA 621P, Carl Zeiss Meditec AG, Germany). Both eyes of each patient were randomized, with one eye assigned to the FLACS group and the other eye to the CCS group. One, 6 and 12 months after surgery, 2 different swept-source optical coherence tomography measurements (IOLMaster 700, Carl Zeiss Meditec AG, Germany and CASIA-2, Tomey GmbH, Japan) were performed as well as subjective refraction, best corrected (BCDVA) and uncorrected visual acuity (UDVA).

RESULTS

A total of 74 eyes of 37 patients were included in this study. Mean postoperative BCDVA for the FLACS and CCS group was - 0.08 ± 0.08 logMAR and 0.08 ± 0.07 logMAR, respectively. Overall, mean absolute error (MAE) and mean error (ME) was 0.48 ± 0.38dpt and 0.42 ± 0.44dpt respectively with no differences between groups (p = 0.559 and p = 0.786). Overall, tilt magnitude was stable in all groups over the course of 12 months with a mean tilt magnitude of 4.48 ± 2.48° at 12 months. Postoperative patient satisfaction was high with 97.3% of all patients very or fairly satisfied with the outcome.

CONCLUSION

There was no significant difference between groups regarding postoperative stability and capsular bag performance as well as refractive error over the course of 12 months. The CT LUCIA 621P demonstrated good efficacy, safety and stability. No issues regarding biocompatibility of the IOL material were observed.

摘要

目的

评估一种新型疏水非球面人工晶状体(IOL)在传统白内障超声乳化手术(CCS)或飞秒激光辅助白内障手术(FLACS)后的屈光稳定性和位置稳定性。

方法

所有患者均植入同一型号的人工晶状体(CT LUCIA 621P,德国卡尔蔡司医疗技术公司)。每位患者的双眼随机分组,一只眼分配至FLACS组,另一只眼分配至CCS组。术后1个月、6个月和12个月,进行2种不同的扫频源光学相干断层扫描测量(德国卡尔蔡司医疗技术公司的IOLMaster 700和日本多美公司的CASIA-2)以及主观验光、最佳矫正视力(BCDVA)和未矫正视力(UDVA)检查。

结果

本研究共纳入37例患者的74只眼。FLACS组和CCS组术后平均BCDVA分别为-0.08±0.08 logMAR和0.08±0.07 logMAR。总体而言,平均绝对误差(MAE)和平均误差(ME)分别为0.48±0.38 dpt和0.42±0.44 dpt,两组之间无差异(p = 0.559和p = 0.786)。总体而言,在12个月的观察期内,所有组的倾斜度均保持稳定,12个月时平均倾斜度为4.48±2.48°。术后患者满意度较高,97.3%的患者对手术结果非常满意或比较满意。

结论

在12个月的观察期内,两组在术后稳定性、囊袋性能以及屈光不正方面无显著差异。CT LUCIA 621P人工晶状体显示出良好的有效性、安全性和稳定性。未观察到人工晶状体材料生物相容性方面的问题。

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