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双焦点和三焦点衍射型人工晶状体的视觉性能:一项前瞻性三臂随机多中心临床试验。

Visual Performance With Bifocal and Trifocal Diffractive Intraocular Lenses: A Prospective Three-Armed Randomized Multicenter Clinical Trial.

作者信息

Kaymak Hakan, Breyer Detlev, Alió Jorge L, Cochener Beatrice

出版信息

J Refract Surg. 2017 Oct 1;33(10):655-662. doi: 10.3928/1081597X-20170504-04.

Abstract

PURPOSE

To evaluate and compare quality of vision and reading performance outcomes after implantation of bifocal refractive-diffractive, bifocal apodized diffractive, or trifocal diffractive-refractive intraocular lenses (IOLs).

METHODS

This randomized, prospective, three-armed multicenter (Spain, Germany, and France) trial included 104 eyes of 52 patients (mean age: 63.2 ± 7.7 years). Patients underwent cataract surgery with bilateral implantation of either AT LISA 809M (Carl Zeiss Meditec, Jena, Germany: AT LISA group, 38 eyes), AT LISA tri 839MP (Carl Zeiss Meditec: AT LISA tri group, 32 eyes), or ReSTOR SN6AD1 (Alcon Laboratories, Inc., Fort Worth, TX: ReSTOR group, 34 eyes) IOLs. Visual and refractive outcomes, depth of focus, and reading performance were evaluated at 1, 6, and 12 months postoperatively.

RESULTS

The AT LISA tri group showed significantly better 12-month uncorrected (UIVA) and binocular distance-corrected (DCIVA) intermediate visual acuity (P ≤ .016) than the AT LISA group. The AT LISA tri group showed a significantly better 3-month UIVA compared to the ReSTOR group (P = .042). Binocular uncorrected and corrected distance visual acuities were not significantly different among groups (P ≥ .092) at the 12-month follow-up. A total of 85.3%, 90.0%, and 78.1% of eyes had a spherical equivalent within ±0.50 D in the AT LISA, AT LISA tri, and ReSTOR groups, respectively, at 12 months (P = .038). No statistically significant differences between the trifocal and bifocal groups were detected for reading performance (P ≥ .055).

CONCLUSIONS

The trifocal diffractive-refractive IOL provides enhanced intermediate visual restoration compared to bifocal diffractive-refractive or apodized diffractive IOLs. The addition of an intermediate focal point did not deteriorate far or near vision. A comparable reading performance was maintained with the trifocal lens. [J Refract Surg. 2017;33(10):655-662.].

摘要

目的

评估和比较双焦点折射-衍射型、双焦点变迹衍射型或三焦点衍射-折射型人工晶状体(IOL)植入术后的视力质量和阅读性能结果。

方法

这项随机、前瞻性、三臂多中心(西班牙、德国和法国)试验纳入了52例患者的104只眼(平均年龄:63.2±7.7岁)。患者接受白内障手术,双眼植入AT LISA 809M(德国耶拿卡尔蔡司医疗技术公司:AT LISA组,38只眼)、AT LISA tri 839MP(卡尔蔡司医疗技术公司:AT LISA tri组,32只眼)或ReSTOR SN6AD1(美国德克萨斯州沃思堡爱尔康实验室公司:ReSTOR组,34只眼)IOL。在术后1、6和12个月评估视觉和屈光结果、焦深和阅读性能。

结果

AT LISA tri组在术后12个月的未矫正(UIVA)和双眼距离矫正(DCIVA)中间视力方面显著优于AT LISA组(P≤0.016)。与ReSTOR组相比,AT LISA tri组在术后3个月的UIVA显著更好(P = 0.042)。在12个月随访时,各组之间的双眼未矫正和矫正远视力无显著差异(P≥0.092)。在术后12个月时,AT LISA组、AT LISA tri组和ReSTOR组分别有85.3%、90.0%和78.1%的眼等效球镜度在±0.50 D以内(P = 0.038)。三焦点组和双焦点组在阅读性能方面未检测到统计学显著差异(P≥0.055)。

结论

与双焦点折射-衍射型或变迹衍射型IOL相比,三焦点衍射-折射型IOL可提供更好的中间视力恢复。增加一个中间焦点并未使远视力或近视力恶化。三焦点晶状体保持了相当的阅读性能。[《屈光手术杂志》。2017;33(10):655 - 662。]

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