优质单眼视力与双侧近视性单眼视力、混合性单眼视力及双侧三焦点人工晶状体植入术的比较研究
Premium Monovision versus Bilateral Myopic Monovision, Hybrid Monovision and Bilateral Trifocal Implantation: A Comparative Study.
作者信息
Labiris Georgios, Panagiotopoulou Eirini-Kanella, Perente Asli, Ntonti Panagiota, Delibasis Konstantinos, Fotiadis Ioannis, Konstantinidis Aristeidis, Dardabounis Doukas
机构信息
Department of Ophthalmology, University Hospital of Alexandroupolis, Dragana, 68100, Alexandroupolis, Greece.
Department of Computer Science and Biomedical Informatics, University of Thessaly, Lamia, 35131, Greece.
出版信息
Clin Ophthalmol. 2022 Mar 4;16:619-629. doi: 10.2147/OPTH.S351091. eCollection 2022.
PURPOSE
Contemporary monovision techniques use premium intraocular lenses (IOLs), either in both eyes or at least in the non-dominant one. Primary objective of this study was to compare the efficacy of premium monovision (implantation of the trifocal diffractive Panoptix IOL in the non-dominant eye and the bifocal hybrid refractive-diffractive Restor IOL in the dominant eye), against bilateral myopic monovision (implantation of the monofocal SN60WF IOL targeting -0.50 D in the dominant eye and -1.25 D myopia in the non-dominant one), hybrid monovision (implantation of Panoptix in the non-dominant eye and SN60WF in the dominant eye) and bilateral trifocal implantation (with bilateral Panoptix implantation).
METHODS
This is a prospective, comparative, clinic-based trial. Cataract patients populated four study groups: Monovision Group (MoG), Multifocal Lens Group (MfG), Hybrid Monovision Group (HmG) and Premium Monovision Group (PmG). Binocular Uncorrected Distance Visual Acuity (UDVA), Uncorrected Reading Acuity and Critical Print Size at 60cm (UIRA, UICPS) and at 40cm (UNRA, UNCPS), contrast sensitivity, vision-related functional impairment, dysphotopsia symptoms and spectacle dependence were evaluated 6 months following the operation of the second eye. A mathematical model was constructed, which calculated the relative efficacy of each surgical intervention.
RESULTS
A total of 120 participants were recruited and populated equally the study groups. Significant improvement of preoperative UDVA was observed in all study groups. No significant differences could be detected in postoperative UDVA and UIRA (p = 0.24) among study groups, while significant differences were noticed in UICPS (p = 0.04), UNRA (p = 0.02) and UNCPS (p = 0.01). Dysphotopic phenomena (glare and shadows) were significantly more in the MfG arm followed by the PmG group (p = 0.04 and p = 0.02, respectively), while perceived difficulty and spectacle independence rates were significantly better in PmG group. PmG presented the best overall relative efficacy.
CONCLUSION
All surgical techniques present satisfactory outcomes. Premium monovision seems to demonstrate the best outcomes.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04618380. Registered 05 November 2020, https://clinicaltrials.gov/ct2/show/NCT04618380.
目的
当代单眼视力技术使用高端人工晶状体（IOL），可用于双眼或至少非优势眼。本研究的主要目的是比较高端单眼视力（在非优势眼植入三焦点衍射型Panoptix人工晶状体，在优势眼植入双焦点折射 - 衍射型Restor人工晶状体）与双侧近视性单眼视力（在优势眼植入目标屈光度为 -0.50 D的单焦点SN60WF人工晶状体，在非优势眼植入 -1.25 D近视的人工晶状体）、混合单眼视力（在非优势眼植入Panoptix人工晶状体，在优势眼植入SN60WF人工晶状体）以及双侧三焦点植入（双侧植入Panoptix人工晶状体）的疗效。
方法
这是一项基于临床的前瞻性比较试验。白内障患者分为四个研究组：单眼视力组（MoG）、多焦点晶状体组（MfG）、混合单眼视力组（HmG）和高端单眼视力组（PmG）。在第二只眼手术后6个月，评估双眼未矫正远视力（UDVA）、未矫正近视力以及60cm（UIRA、UICPS）和40cm（UNRA、UNCPS）处的临界印刷字体大小、对比敏感度、视力相关功能损害、眩光症状和对眼镜的依赖程度。构建了一个数学模型，计算每种手术干预的相对疗效。
结果
共招募了120名参与者，平均分配到各研究组。所有研究组术前UDVA均有显著改善。各研究组术后UDVA和UIRA无显著差异（p = 0.24），而UICPS（p = 0.04）、UNRA（p = 0.02）和UNCPS（p = 0.01）有显著差异。多焦点晶状体组的眩光现象（眩光和阴影）明显更多，其次是高端单眼视力组（分别为p = 0.04和p = 0.02），而高端单眼视力组的感知困难和不依赖眼镜率明显更好。高端单眼视力组总体相对疗效最佳。
结论
所有手术技术均呈现出令人满意的结果。高端单眼视力似乎显示出最佳效果。
试验注册
ClinicalTrials.gov，NCT04618380。于2020年11月5日注册，https://clinicaltrials.gov/ct2/show/NCT04618380。
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