Yadav Shikha, Sahay Pranita, Maharana Prafulla K, Titiyal Jeewan S, Vajpayee Rasik B, Sharma Namrata
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
Vision Eye Institute, Royal Victorian Eye and Ear Hospital, North West Academic Centre, University of Melbourne, Australia.
Indian J Ophthalmol. 2017 Dec;65(12):1445-1449. doi: 10.4103/ijo.IJO_757_17.
Monofocal aspheric intraocular lenses (IOLs) provide better visual outcome compared to other available IOLs following cataract surgery. However, the imported IOLs are expensive and are not affordable by all subset of patients in low- to middle-income countries like India. The aim of this study is to compare the safety and efficacy of a relatively low cost indigenous IOL (Acriol EC) with an imported aspheric IOL (AcrySof IQ).
A randomized controlled trial was conducted at a tertiary care centre. Two hundred and five eyes of 137 patients >45 years of age with uncomplicated age-related cataract were recruited. All cases underwent standard phacoemulsification and randomly assigned to one of the IOL implantations (Group I: AcrySof IOL; Group II: Acriol EC IOL). Primary outcome measure was best-corrected visual acuity (BCVA). Secondary outcomes included visual function (VF) score, spherical equivalent, contrast sensitivity, optical aberrations, and posterior capsular opacification. Independent t-test to compare two means; Mann-Whitney test; Pearson's Chi-square test, and McNemar's test were used for analyzing the nonparametric data such as incidence of posterior capsule opacification.
There was no significant difference in the mean postoperative BCVA at 1, 3, 6, and 12 months in either group (P > 0.05). The contrast sensitivity, wavefront aberrations, VF score, and posterior capsular opacification were comparable between the groups except for higher-order aberrations and spherical aberration, which were higher in Group II.
Acriol EC IOL provides visual outcomes comparable to other commonly used aspheric IOLs with comparable safety and efficacy at an affordable cost.
与白内障手术后其他可用的人工晶状体相比,单焦点非球面人工晶状体(IOL)可提供更好的视觉效果。然而,进口的人工晶状体价格昂贵,像印度这样的低收入和中等收入国家的所有患者群体都难以承受。本研究的目的是比较一种成本相对较低的国产人工晶状体(Acriol EC)与进口非球面人工晶状体(AcrySof IQ)的安全性和有效性。
在一家三级医疗中心进行了一项随机对照试验。招募了137例年龄大于45岁、患有单纯年龄相关性白内障的患者的205只眼睛。所有病例均接受标准超声乳化手术,并随机分配到一种人工晶状体植入组(第一组:AcrySof人工晶状体;第二组:Acriol EC人工晶状体)。主要结局指标是最佳矫正视力(BCVA)。次要结局包括视觉功能(VF)评分、球镜等效度、对比敏感度、光学像差和后囊膜混浊。使用独立t检验比较两个均值;使用曼-惠特尼检验、皮尔逊卡方检验和麦克尼马尔检验分析后囊膜混浊发生率等非参数数据。
两组在术后1、3、6和12个月时的平均最佳矫正视力均无显著差异(P>0.05)。除高阶像差和球差外,两组之间的对比敏感度、波前像差、VF评分和后囊膜混浊情况相当,其中第二组的高阶像差和球差更高。
Acriol EC人工晶状体在可承受的成本下,提供了与其他常用非球面人工晶状体相当的视觉效果,安全性和有效性相当。