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      Implantable collamer lens with central hole: 3-year follow-up


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          To evaluate the long-term predictability, stability, safety, and efficacy of the V4c Visian implantable collamer lens (ICL) with central hole to correct myopia.

          Patients and methods

          One hundred and eighty-four eyes of 92 patients were evaluated during 3 years after implantation of the V4c ICL. The refraction, uncorrected distance visual acuity, best-corrected distance visual acuity, IOP, endothelial cell count, vault, and adverse effects were evaluated every 12 months during the whole follow-up.


          The mean spherical equivalent dropped from -8.30±2.98 D preoperatively to −0.37±0.47 D at 36 months post-surgery, with 91.8% eyes being within ±1.00 D of emmetropia. With respect to the astigmatic components J0 and J45, 98.4% and 99.5% of eyes, respectively, were within ±0.50 D of the desired refraction. At 36 months, 78.8% of eyes had no change in the Snellen lines of best-corrected distance visual acuity, while 8.7% gained one line and 6.5% gained two or more lines; mean safety and efficacy indexes were 1.03 and 0.90, respectively. Mean endothelial cell count was 2,742±340 cells/mm 2 before and 2,663±366 cells/mm 2 at 36 months post-surgery. Mean IOP reduced from 13.7±1.9 mmHg preoperatively to 12.8±1.7 mmHg at 36 months post-surgery. Mean vault varied from 409±196 µm at 12 months to 349±165 µm at 36 months.


          The visual and refractive outcomes were very good and highly stable throughout the follow-up period, indicating that this ICL model may be predictable, stable, safe, and effective to correct myopia in the long term.

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          Most cited references37

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          Meta-analysis and review: effectiveness, safety, and central port design of the intraocular collamer lens

          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.
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            Implantable collamer posterior chamber intraocular lenses: a review of potential complications.

            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.
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              Phakic intraocular lens implantation for the correction of myopia: a report by the American Academy of Ophthalmology.

              To review the published literature for evaluation of the safety and outcomes of phakic intraocular lens (pIOL) implantation for the correction of myopia and myopic astigmatism. Literature searches of the PubMed and Cochrane Library databases were conducted on October 7, 2007, and July 14, 2008. The PubMed search was limited to the English language; the Cochrane Library was searched without language limitations. The searches retrieved 261 references. Of these, panel members chose 85 papers that they considered to be of high or medium clinical relevance to this assessment. The panel methodologist rated the articles according to the strength of evidence. Two pIOLs have been approved by the US Food and Drug Administration (FDA): one iris-fixated pIOL and one posterior-chamber IOL. In FDA trials of iris-fixated pIOLs, uncorrected visual acuity (UCVA) was >or=20/40 in 84% and >or=20/20 in 31% after 3 years. In FDA trials of posterior-chamber pIOLs, UCVA was >or=20/40 in 81% and >or=20/20 in 41%. Satisfaction with the quality of vision with both types of pIOLs was generally high. Toric anterior- and posterior-chamber pIOLs have shown improved clinical results in European trials compared with spherical pIOLs. Comparative studies showed pIOLs to provide better best spectacle-corrected visual acuity (BSCVA) and refractive predictability and stability compared with LASIK and photorefractive keratectomy and to have a lower risk of retinal detachment compared with refractive lens exchange. Reported complications and long-term safety concerns include endothelial cell loss, cataract formation, secondary glaucoma (pupillary block, pigment dispersion), iris atrophy (pupil ovalization), and traumatic dislocation. Phakic IOL implantation is effective in the correction of myopia and myopic astigmatism. In cases of high myopia of -8 diopters or more, pIOLs may provide a better visual outcome than keratorefractive surgeries and better safety than refractive lens exchange. The short-term rates of complications and loss of BSCVA are acceptable. Comprehensive preoperative evaluation and long-term postoperative follow-up examinations are needed to monitor for and prevent serious complications, and to establish long-term safety.

                Author and article information

                Clin Ophthalmol
                Clin Ophthalmol
                Clinical Ophthalmology
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove Medical Press
                11 October 2018
                : 12
                : 2015-2029
                [1 ]Department of Surgery, Fernández-Vega Ophthalmological Institute, Oviedo, Spain, j.alfonso@ 123456fernandez-vega.com
                [2 ]Department of Optics and Optometry and Visual Sciences, University of Valencia, Valencia, Spain
                [3 ]School of Medicine, University of Oviedo, Oviedo, Spain, j.alfonso@ 123456fernandez-vega.com
                Author notes
                Correspondence: José F Alfonso, Instituto Oftalmológico Fernández-Vega, Avda Dres Fernández-Vega 114, Oviedo, 33012, Spain, Tel +34 98 524 5533, Fax +34 98 523 3288, Email j.alfonso@ 123456fernandez-vega.com
                © 2018 Fernández-Vega-Cueto et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Original Research

                Ophthalmology & Optometry
                phakic intraocular lens,implantable collamer lens,visian icl,long-term evaluation


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