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两种用于微型单眼视力的新型扩展焦深人工晶状体:一项前瞻性随机对照试验。

Two novel extended depth-of-focus intraocular lenses targeted for mini-monovision: A prospective randomized controlled trial.

作者信息

Wanten Joukje C, Bauer Noël J C, Berendschot Tos T J M, van den Biggelaar Frank J H M, Nuijts Rudy M M A

机构信息

From the University Eye Clinic Maastricht, Maastricht University Medical Center(+), Maastricht, The Netherlands.

From the University Eye Clinic Maastricht, Maastricht University Medical Center(+), Maastricht, The Netherlands.

出版信息

Am J Ophthalmol. 2025 Aug;276:286-296. doi: 10.1016/j.ajo.2025.04.024. Epub 2025 Apr 24.

Abstract

PURPOSE

To compare the visual outcomes of two extended depth-of-focus (EDOF) intraocular lenses (IOLs).

DESIGN

Single-center prospective randomized controlled trial.

METHODS

Patients undergoing bilateral cataract surgery were randomly assigned to receive either the Acunex Vario IOL (Teleon Surgical B.V., Spankeren, The Netherlands) or the AcrySof IQ Vivity IOL (Alcon Laboratories Inc., Fort Worth, United States of America); both Vario-group and Vivity-group were targeted for mini-monovision. The primary outcome was the uncorrected intermediate visual acuity (UIVA, measured at 66cm). Secondary outcome parameters were uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), defocus curves, reading speed, contrast sensitivity, spectacle independence and quality of vision.

SETTING

University Eye Clinic, Maastricht University Medical Center+, the Netherlands.

RESULTS

A total of 31 subjects (62 eyes) were included, 16 patients were enrolled into the Vario-group and 15 patients into the Vivity-group. At three months postoperatively, no statistically significant differences were found for the binocular visual acuities between the groups after adjustment for covariates. The mean and standard deviation for the binocular UIVA was 0.04±0.11 and 0.15±0.11 logMAR (adjusted-P=0.264) for the Vario-group and Vivity-group, respectively. The binocular UDVA was 0.00±0.14 and 0.08±0.10 logMAR (adjusted-P=0.753), and UNVA was 0.22±0.17 and 0.31±0.14 logMAR (adjusted-P=0.235), for both groups, respectively. While the Vario-group had a larger range of defocus, no significant differences were found for patient satisfaction and spectacle independence. Contrast sensitivity and reading speed were comparable, and there were no statistically significant differences in optical side effects between the groups.

CONCLUSION

Bilateral implantation of the Acunex Vario IOL and the AcrySof IQ Vivity IOL targeted for mini-monovision had comparable results for binocular visual acuity outcomes, contrast sensitivity, optical side effects, and reading speed. The Vario-group showed a larger continuous range of defocus.

摘要

目的

比较两种扩展景深(EDOF)人工晶状体(IOL)的视觉效果。

设计

单中心前瞻性随机对照试验。

方法

接受双侧白内障手术的患者被随机分配接受Acunex Vario人工晶状体(荷兰斯帕肯伦Teleon Surgical B.V.公司)或AcrySof IQ Vivity人工晶状体(美国沃思堡爱尔康实验室公司);Vario组和Vivity组均采用微单眼视力矫正方案。主要结局指标为未矫正的中间视力(UIVA,在66厘米处测量)。次要结局参数包括未矫正的远视力(UDVA)、未矫正的近视力(UNVA)、散焦曲线、阅读速度、对比敏感度、眼镜依赖度和视觉质量。

地点

荷兰马斯特里赫特大学医学中心+大学眼科诊所。

结果

共纳入31名受试者(62只眼),16例患者被纳入Vario组,15例患者被纳入Vivity组。术后三个月,在对协变量进行调整后,两组间的双眼视力无统计学显著差异。Vario组和Vivity组的双眼UIVA的平均值及标准差分别为0.04±0.11和0.15±0.11 logMAR(校正P = 0.264)。两组的双眼UDVA分别为0.00±0.14和0.08±0.10 logMAR(校正P = 0.753),UNVA分别为0.22±0.17和0.31±0.14 logMAR(校正P = 0.235)。虽然Vario组的散焦范围更大,但患者满意度和眼镜依赖度方面未发现显著差异。对比敏感度和阅读速度相当,两组间在光学副作用方面无统计学显著差异。

结论

针对微单眼视力矫正方案双侧植入Acunex Vario人工晶状体和AcrySof IQ Vivity人工晶状体,在双眼视力结局、对比敏感度、光学副作用和阅读速度方面结果相当。Vario组显示出更大的连续散焦范围。

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