Packer Mark
Mark Packer MD Consulting, Inc., Boulder, CO, USA.
Clin Ophthalmol. 2016 Jun 9;10:1059-77. doi: 10.2147/OPTH.S111620. eCollection 2016.
The purpose of this review is to summarize relevant data from publications appearing in the peer-reviewed scientific literature over the past decade since US Food and Drug Administration approval of the implantable collamer lens (ICL), and, in particular, to review studies relating to sizing methodology, safety, and effectiveness, as well as more recent studies reporting clinical outcomes of the V4c Visian ICL with KS Aquaport, VICMO. A literature search was conducted using two databases, PubMed.gov and Science.gov, to identify all articles published after 2005 related to the Visian ICL (STAAR Surgical, Inc.). Articles were examined for their relevance to sizing methodology, clinical safety, and effectiveness, and the references cited in each article were also searched for additional relevant publications. The literature review revealed that all currently reported methods of determining the best-fit size of the ICL achieve similarly satisfactory results in terms of vault, the safe distance between the crystalline lens and the ICL. Specifically, meta-analysis demonstrated that sulcus-to-sulcus and white-to-white measurement-based sizing methods do not result in clinically meaningful nor statistically significant differences in vault (two-sample two-sided t-test using pooled mean and standard deviations; t (2,594)=1.33; P=0.18). The reported rates of complications related to vault are very low, except in two case series where additional risk factors such as higher levels of myopia and older age impacted the incidence of cataract. On the basis of preclinical studies and initial clinical reports, with up to 5 years of follow-up, the new VICMO central port design holds promise for further reduction of complications. Given its safety record and the significant improvement in vision and quality of life that the ICL makes possible, the benefits of ICL implantation outweigh the risks.
本综述的目的是总结自美国食品药品监督管理局批准可植入式胶原晶状体(ICL)以来过去十年间同行评审科学文献中发表的相关数据,特别是回顾与尺寸确定方法、安全性和有效性相关的研究,以及最近报告带有KS Aquaport的V4c Visian ICL(VICMO)临床结果的研究。使用两个数据库PubMed.gov和Science.gov进行文献检索,以识别2005年后发表的所有与Visian ICL(STAAR Surgical公司)相关的文章。检查文章与尺寸确定方法、临床安全性和有效性的相关性,并搜索每篇文章中引用的参考文献以查找其他相关出版物。文献综述表明,就晶状体与ICL之间的安全距离——房角而言,目前所有报告的确定ICL最佳适配尺寸的方法都取得了同样令人满意的结果。具体而言,荟萃分析表明,基于沟到沟和白到白测量的尺寸确定方法在房角方面不会导致临床上有意义的差异,也不会导致统计学上的显著差异(使用合并均值和标准差的双样本双侧t检验;t(2,594)=1.33;P=0.18)。除了两个病例系列中,如近视程度较高和年龄较大等其他风险因素影响了白内障的发生率外,与房角相关的并发症报告发生率非常低。基于临床前研究和初始临床报告,随访长达5年,新的VICMO中央端口设计有望进一步降低并发症。鉴于其安全记录以及ICL使视力和生活质量得到显著改善,ICL植入的益处大于风险。