Drs Fine, Hoffman & Packer, LLC, Eugene, OR97401-7700, USA.
Am J Ophthalmol. 2010 Apr;149(4):577-584.e1. doi: 10.1016/j.ajo.2009.10.022. Epub 2010 Feb 6.
To evaluate the safety and effectiveness of the aspheric diffractive Tecnis multifocal ZM900 (TCMF) intraocular lens (IOL; Abbott Medical Optics, Inc, Santa Ana, California, USA).
One-year, nonrandomized, multicenter, evaluator-masked, bilateral, parallel-group comparative clinical evaluation.
Subjects underwent bilateral implantation with the TCMF IOL or the CeeOn 911A monofocal (CEMN) IOL (Abbott Medical Optics, Inc) according to subject preference.
One-year results were available for 244 eyes of 125 TCMF IOL subjects and for 245 eyes of 123 CEMN IOL subjects. Mean distance visual acuities (VAs) were statistically and clinically equivalent between the 2 groups. Mean binocular and monocular uncorrected and distance-corrected near VAs were significantly better for the TCMF IOL versus the CEMN IOL group (P < .0001). A greater proportion of TCMF IOL versus CEMN IOL subjects achieved binocular combined VAs of 20/25 distance and 20/32 near (84.2% [96/114] vs 6.2% [7/113]; P < .0001). The TCMF IOL group had excellent depth of focus, maintaining a mean of 20/40 or better for far, intermediate, and near distances. Mean contrast sensitivity scores were lower for the TCMF IOL versus the CEMN IOL group, but the differences were not considered clinically significant. Halos and night glare were more common in the TCMF IOL versus the CEMN IOL groups. Both reading acuity (20/20 vs 20/47; P < .0007) and speed (148 vs 117 words/minute; P < .0001) were significantly better for the TCMF IOL versus the CEMN IOL group, as were the proportions of the TCMF IOL group versus the CEMN IOL group that achieved spectacle independence (84.8% vs 5.2%; P < .0001) and that functioned comfortably at near without glasses (96.4% vs 30.4%; P < .0001).
The TCMF IOL provided enhanced near VA, reading acuity per speed, depth of focus, and spectacle independence compared with the monofocal IOL.
评估非球面衍射 Tecnis 多焦点 ZM900（TCMF）人工晶状体（IOL；雅培医疗光学公司，加利福尼亚州圣安娜，美国）的安全性和有效性。
为期一年、非随机、多中心、评估者盲法、双侧、平行组比较临床评估。
根据患者的偏好，对患者进行双侧 TCMF IOL 或 CeeOn 911A 单焦点（CEMN）IOL（雅培医疗光学公司）植入。
244 只眼的 125 例 TCMF IOL 患者和 245 只眼的 123 例 CEMN IOL 患者可提供一年的结果。两组之间的平均远距离视力（VA）在统计学上和临床上是等效的。与 CEMN IOL 组相比，TCMF IOL 组的双眼和单眼未矫正及远距离矫正近视力明显更好（P <.0001）。与 CEMN IOL 组相比，更多的 TCMF IOL 患者达到了双眼组合的远距离 20/25 和近距 20/32 的视力（84.2%[96/114]与 6.2%[7/113]；P <.0001）。TCMF IOL 组的景深极佳，远、中、近距离的平均保持 20/40 或更好。与 CEMN IOL 组相比，TCMF IOL 组的平均对比敏感度评分较低，但差异无临床意义。TCMF IOL 组的光晕和夜间眩光比 CEMN IOL 组更常见。与 CEMN IOL 组相比，TCMF IOL 组的阅读视力（20/20 与 20/47；P <.0007）和速度（148 与 117 个单词/分钟；P <.0001）均明显更好，以及 TCMF IOL 组与 CEMN IOL 组的不依赖眼镜的比例（84.8%与 5.2%；P <.0001）和舒适地不戴眼镜近距离工作的比例（96.4%与 30.4%；P <.0001）均明显更高。
与单焦点 IOL 相比，TCMF IOL 提供了更好的近视力、阅读速度/视力、景深和不依赖眼镜的视力。
