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功能后双边植入非球面衍射丙烯酸人工晶状体加 3.0 或 +4.0 屈光度添加功率随机多中心临床研究。

Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power Randomized multicenter clinical study.

机构信息

California Eye Institute, 1360 East Herndon, Suite 410, Fresno, California 93720, USA.

出版信息

J Cataract Refract Surg. 2009 Dec;35(12):2054-61. doi: 10.1016/j.jcrs.2009.06.041.

Abstract

PURPOSE

To evaluate functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses (IOLs) with a +3.0 or +4.0 diopter (D) addition (add) power.

SETTING

Twelve study centers in the United States.

METHODS

This randomized patient-masked parallel-group 6-month follow-up study comprised patients having bilateral cataract extraction with implantation of an AcrySof IQ ReSTOR SN6AD3 IOL with a +4.0 D add power (+4.0 D group) or an AcrySof IQ ReSTOR SN6AD1 IOL with a +3.0 D add power (+3.0 D group) (both IOLs, Alcon, Inc.). Visual acuity, defocus testing, patient-reported outcomes, and safety measures were assessed.

RESULTS

Of the 279 patients, 141 were in the +3.0 D group and 138 were in the +4.0 D group. Binocular distance-corrected intermediate visual acuity was statistically significantly better in the +3.0 D group than in the +4.0 D group (P<.0001); there was no difference in binocular near or distance visual acuity. There were no statistically significant differences in visual disturbances between the 2 groups. Patients in both groups reported excellent overall spectacle independence, near visual function, and satisfaction with the IOLs.

CONCLUSIONS

Intermediate vision at a mean reading distance of approximately 40 cm was better with the aspheric IOL with a +3.0 D add than with the aspheric IOL with a +4.0 D add, as shown by the near peak in the mean binocular defocus curve; near and distance acuity were similar between the 2 IOLs. Patients reported excellent overall quality of vision, spectacle independence, and satisfaction.

摘要

目的

评估双侧植入具有+3.0 或+4.0 屈光度(D)附加(add)度数的渐变折射非球面丙烯酸人工晶状体(IOL)后的功能结果。

地点

美国的 12 个研究中心。

方法

本随机患者掩蔽平行组 6 个月随访研究纳入了接受双侧白内障摘除术并植入 AcrySof IQ ReSTOR SN6AD3 IOL(+4.0 D 组)或 AcrySof IQ ReSTOR SN6AD1 IOL(+3.0 D 组)(均为 Alcon,Inc. 公司)的患者。评估了视力、离焦测试、患者报告的结果和安全性措施。

结果

在 279 名患者中,141 名患者在+3.0 D 组,138 名患者在+4.0 D 组。双眼距离矫正中间视力在+3.0 D 组显著优于+4.0 D 组(P<.0001);双眼近视力或远视力无差异。两组之间视觉干扰无统计学显著差异。两组患者均报告了极好的总体眼镜独立性、近视力和对 IOL 的满意度。

结论

与具有+4.0 D add 的非球面 IOL 相比,具有+3.0 D add 的非球面 IOL 在平均阅读距离约为 40 cm 的中间视力更好,这表现为平均双眼离焦曲线的近峰;两种 IOL 的近视力和远视力相似。患者报告了极好的总体视觉质量、眼镜独立性和满意度。

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