不同附加屈光度的三款一体式Tecnis多焦点人工晶状体混合搭配后的视觉及主观结果评估
Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers.
作者信息
Dell Steven J
机构信息
Dell Laser Consultants, Austin, TX, USA.
出版信息
Clin Ophthalmol. 2020 Sep 29;14:2903-2911. doi: 10.2147/OPTH.S266120. eCollection 2020.
PURPOSE
To evaluate visual and subjective outcomes after bilateral mix-and-match implantation of one-piece diffractive multifocal IOLs in different near add powers (+2.75 D, +3.25 D, +4.0 D).
SETTING
Four US clinics.
DESIGN
Prospective, multi-center, parallel comparison clinical study design.
PATIENTS AND METHODS
Two treatment groups received implantation with either the +3.25 D (ZLB00) or the +4.00 D (ZMB00) Tecnis Multifocal 1-piece IOL in their non-dominant eye, and the +2.75 D (ZKB00) Tecnis Multifocal 1-piece IOL in their dominant eye (Abbott Medical Optics, Inc., Santa Ana, CA). Each study patient underwent the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the 1st eye surgery. Visual and subjective outcomes were evaluated at 90 days after 2nd eye surgery for the two groups: +3.25D/+2.75D (n=41) and +4.00D/+2.75D (n=36).
RESULTS
Mean binocular uncorrected distance visual acuities at 90 days postop were 0.02 ± 0.082 (+3.25D/+2.75D) vs 0.07 ± 0.128 (+4.00D/+2.75D) (p=0.025). Mean binocular uncorrected intermediate visual acuities at 90 days postop were 0.14 ± 0.185 (+3.25D/+2.75D) vs 0.26 ± 0.261 (+4.00D/+2.75D) (p=0.024). Mean binocular uncorrected near visual acuities at 90 days postop were 0.06 ± 0.098 (+3.25D/+2.75D) vs 0.19 ± 0.286 (+4.00D/+2.75D) (p=0.018). Over 88% of patients reported "none" for visual symptoms of glare, halos, starburst, or other. Freedom from glasses or contacts was reported by groups +3.25D/+2.75D and +4.00D/+2.75D as follows: distance (95.1% vs 97.1%), intermediate (92.7% vs 94.1%), and near activities (82.9% vs 64.7%).
CONCLUSION
At 90 days postoperatively, both groups demonstrated good visual and subjective outcomes; however, differences in near and intermediate outcomes favored the +3.25/+2.75 IOL combination.
CLINICALTRIALSGOV REGISTRATION
NCT02863159 (08/11/2016).
目的
评估在不同近附加度数（+2.75 D、+3.25 D、+4.0 D）下，双侧混合植入一体式衍射多焦点人工晶状体后的视觉和主观结果。
设置
四家美国诊所。
设计
前瞻性、多中心、平行对照临床研究设计。
患者与方法
两个治疗组在非优势眼植入+3.25 D（ZLB00）或+4.00 D（ZMB00）Tecnis多焦点一体式人工晶状体，在优势眼植入+2.75 D（ZKB00）Tecnis多焦点一体式人工晶状体（雅培医疗光学公司，加利福尼亚州圣安娜）。每位研究患者的每只眼睛都接受相同的常规白内障摘除手术，第二只眼计划在第一只眼手术后7至30天内进行白内障摘除。对两组患者在第二只眼手术后90天评估视觉和主观结果：+3.25D/+2.75D组（n = 41）和+4.00D/+2.75D组（n = 36）。
结果
术后90天，+3.25D/+2.75D组双眼平均未矫正远视力为0.02±0.082，+4.00D/+2.75D组为0.07±0.128（p = 0.025）。术后90天，+3.25D/+2.75D组双眼平均未矫正中视力为0.14±0.185，+4.00D/+2.75D组为0.26±0.261（p = 0.024）。术后90天，+3.25D/+2.75D组双眼平均未矫正近视力为0.06±0.098，+4.00D/+2.75D组为0.19±0.286（p = 0.018）。超过88%的患者报告眩光、光晕、星芒或其他视觉症状为“无”。+3.25D/+2.75D组和+4.00D/+2.75D组报告无需眼镜或隐形眼镜的情况如下：远视力（95.1%对97.1%）、中视力（92.7%对94.1%）和近视力活动（82.9%对64.7%）。
结论
术后90天，两组均显示出良好的视觉和主观结果；然而，近视力和中视力结果的差异有利于+3.25/+2.75人工晶状体组合。
临床试验注册
NCT02863159（2016年8月11日）。
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