Five-Year Follow-up of Correction of Myopia: Posterior Chamber Phakic Intraocular Lens With a Central Port Design

To obtain longitudinal data to estimate long-term morphometric changes in normal human corneal endothelia. Ten years after an initial study, the authors rephotographed the central corneal endothelium of 52 normal subjects with the same contact specular microscope. The findings for the 10 subjects younger than 18 years of age at the initial examination were considered separately. For the remaining 42 adult subjects, the time between examinations averaged 10.6 +/- 0.2 years (range, 10.1 to 11 years). At the recent examination, these subjects' ages averaged 59.5 +/- 16.8 years (range, 30 to 84 years). Outlines of 100 cells for each cornea were digitized. For the 42 adult subjects, the mean endothelial cell density decreased during the 10.6-year interval from 2715 +/- 301 cells/mm2 to 2539 +/- 284 cells/mm2 (P < 0.001). The calculated exponential cell loss rate over this interval was 0.6% +/- 0.5% per year. There was no statistically significant correlation between cell loss rate and age. During the 10.6-year interval, the coefficient of variation of cell area increased from 0.26 +/- 0.05 to 0.29 +/- 0.06 (P < 0.001), and the percentage of hexagonal cells decreased from 67% +/- 8% to 64% +/- 6% (P = 0.003). For the 10 subjects 5 to 15 years of age at the initial examination, the exponential cell loss rate was 1.1% +/- 0.8% per year. Human central endothelial cell density decreases at an average rate of approximately 0.6% per year in normal corneas throughout adult life, with gradual increases in polymegethism and pleomorphism.

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.

To review the peer-reviewed literature reporting postoperative complications of the most recent models of Visian Implantable Collamer posterior chamber intraocular lenses (ICL, STAAR Surgical Co). A literature search of the PubMed database was performed to identify all articles related to ICL complications. Articles were obtained and reviewed to identify those that reported complications using the latest ICL designs. Cataract was the major postoperative complication reported: 136 (5.2%) in 2592 eyes. Of those, 43.4% (n=59) were reported within 1 year, 15.4% (n=21) between 1 and 3 years, and 35.3% (n=48) ≥ 3 years after ICL implantation. Twenty-one (15.4%) cataracts were reported as surgically induced, 46 (33.8%) eyes had poor vault (<200 μm), and cataract surgery was carried out in 27.9% (n=38) of eyes. Early acute intraocular pressure increase was also reported to be relatively frequent, whereas acute pupillary block was less frequent and mostly resolved with additional iridotomies. A total of 42 ICLs were explanted due to cataract and IOP. Reported endothelial cell loss varied from 9.9% at 2 years to 3.7% 4 years postoperatively. This loss was reported to be more pronounced within the first 1 to 2 years, with stability or lower progression after that time. The majority of reported complications after ICL implantation are cataract formation. The improvements in lens geometry and more accurate nomograms applied to the selection of the lens to be implanted, in addition to the surgeon's learning curve, might be factors in the decreased occurrence of postoperative complications reported currently. Copyright 2011, SLACK Incorporated.