Von Tress Mark, Marotta James S, Lane Stephen S, Sarangapani Ramesh
Modeling and Simulation.
IOL Projects.
Clin Ophthalmol. 2018 Jun 22;12:1125-1136. doi: 10.2147/OPTH.S161380. eCollection 2018.
The purpose of this study is to estimate and compare neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomy rates for AcrySof and Clareon intraocular lens (IOL) materials using historical data from the medical literature and Alcon-sponsored clinical studies.
Clinical trials that involved the implantation of AcrySof or Clareon monofocal IOLs in subjects with cataract or presbyopia were extracted from the literature and a company repository of clinical studies. The study duration, number of eyes, and cumulative percent of Nd:YAGs for posterior capsule opacification were extracted. Bayesian random effects meta-analyses were conducted to estimate and compare outcomes for the 2 different IOL materials.
A Bayesian random effects, meta-analysis was performed that combined a literature review of published AcrySof Nd:YAG posterior capsulotomy rates and Nd:YAG rates observed in Alcon-sponsored clinical studies of AcrySof and Clareon. Sixteen Alcon studies contained Nd:YAG data suitable for meta-analysis. Three of these Alcon studies contained results for the Clareon material (2 one-year studies, and 1 three-year study). The literature review included 50 papers from 1998 to 2015. In combination, 30,891 eyes were available for analysis and 2040 Nd:YAG procedures were reported in studies with a follow-up duration ranging in length from 4 months to 10 years. The overall probability of performing a Nd:YAG capsulotomy within a year of implant for AcrySof was 1.44% (1.11% to 1.83%) and 0.62% (0.21% to 1.38%) for Clareon. There was small improvement in the probability of Nd:YAG within a year of implant for Clareon lenses of about 0.82% with a 95% credible interval of (0.07% to 1.36%) at 1 year. Results were similar for incidence rates per 100 surgeries in a year: 0.62 (0.21 to 1.40) for Clareon, 1.46 (1.12 to 1.87) for AcrySof, and the difference was 0.84 (0.07 to 1.39) favoring Clareon. At 3 years, the overall probability of performing a Nd:YAG capsulotomy for AcrySof was 4.19% (3.24% to 5.30%) compared with only 1.82% (0.63% to 4.02%) for Clareon.
A meta-analysis of Clareon multi-piece and single-piece clinical data predicts that the cumulative Clareon Nd:YAG probability will be ≤ AcrySof by 2.37% (0.18% to 3.91%) at 3 years. The results indicate that Clareon is likely to perform as well as, and possibly better than, AcrySof in terms of Nd:YAG capsulotomy rates.
本研究旨在利用医学文献和爱尔康赞助的临床研究中的历史数据，估算并比较AcrySof和Clareon人工晶状体（IOL）材料的钕掺杂钇铝石榴石（Nd:YAG）囊切开术发生率。
从文献以及公司临床研究资料库中提取涉及在白内障或老花眼患者中植入AcrySof或Clareon单焦点IOL的临床试验。提取研究持续时间、眼数以及后囊膜混浊的Nd:YAG累积百分比。进行贝叶斯随机效应荟萃分析，以估算和比较两种不同IOL材料的结果。
进行了贝叶斯随机效应荟萃分析，该分析结合了已发表的AcrySof Nd:YAG后囊切开术发生率的文献综述以及在爱尔康赞助的AcrySof和Clareon临床研究中观察到的Nd:YAG发生率。16项爱尔康研究包含适合进行荟萃分析的Nd:YAG数据。其中3项爱尔康研究包含Clareon材料的结果（2项为期一年的研究和1项为期三年的研究）。文献综述涵盖了1998年至2015年的50篇论文。综合起来，有30891只眼可用于分析，在随访时间从4个月到10年不等的研究中报告了2040例Nd:YAG手术。AcrySof在植入后一年内进行Nd:YAG囊切开术的总体概率为1.44%（1.11%至1.83%），Clareon为0.62%（0.21%至1.38%）。Clareon晶状体在植入后一年内进行Nd:YAG的概率有小幅提高，约为0.82%，1年时95%可信区间为（0.07%至1.36%）。每年每100例手术的发生率结果相似：Clareon为0.62（0.21至1.40），AcrySof为1.46（1.12至1.87），差异为0.84（0.07至1.39），有利于Clareon。在3年时，AcrySof进行Nd:YAG囊切开术的总体概率为4.19%（3.24%至5.30%），而Clareon仅为1.82%（0.63%至4.02%）。
对Clareon多片式和单片式临床数据的荟萃分析预测，在3年时Clareon的Nd:YAG累积概率将比AcrySof低2.37%（0.18%至3.91%）。结果表明，在Nd:YAG囊切开术发生率方面，Clareon的表现可能与AcrySof相当，甚至可能更好。
