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      Posterior chamber collagen copolymer phakic intraocular lens with a central hole for moderate-to-high myopia : First experience in China

      research-article
      , MD a , , MD b , , MD a , , MD a , , MD, PhD a , , MD, PhD a
      Medicine
      Wolters Kluwer Health
      central hole, Chinese, implantable collamer lens, myopia, phakic intraocular lens

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          Abstract

          The purpose of this article is to evaluate the clinical outcomes of a posterior chamber phakic intraocular lens (pIOL) (Visian Implantable Collamer Lens V4c) for the correction of moderate to high myopia in Chinese eyes.

          The article is designed as a retrospective case series.

          This study included the first consecutive eyes that had implantation of a new pIOL design with a central hole, at our department by the same surgeon. The safety, efficacy, predictability, stability, and adverse events of the surgery were evaluated over 6 months.

          The study enrolled 63 eyes (32 patients). The mean spherical equivalent decreased from −12.81 ± 3.11 diopters (D) preoperatively to −0.05 ± 0.27 D 6 months postoperatively; 96.8% of eyes were within ±0.50 D of the target and 100% of eyes were within ±1.00 D. All eyes had a decimal uncorrected distance visual acuity of 0.5 (20/40) or better at every follow-up visit. The safety and efficacy indices were 1.42 ± 0.34 and 1.11 ± 0.19, respectively. Postoperatively, the intraocular pressure (IOP) remained stable over time. No significant rises in IOP (including pupillary block) and no secondary cataract were found. After 6 months, the mean vault was 505.2 ± 258.9 μm (range 120–990 μm), and the mean endothelial cell loss was 2.0%.

          Implantation of the pIOL was safe, effective, predictable, and stable in the correction of moderate-to-high myopia in Han Chinese patients, even without peripheral iridectomy.

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          Most cited references35

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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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            Early clinical outcomes of implantation of posterior chamber phakic intraocular lens with a central hole (Hole ICL) for moderate to high myopia.

            To assess the early clinical outcomes of an ICL with a central hole (Hole ICL) implantation for the correction of moderate to high myopia.
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              Four-year follow-up of posterior chamber phakic intraocular lens implantation for moderate to high myopia.

              To assess the long-term clinical outcomes of implantation of a lens consisting of a biocompatible collagen copolymer (Visian implantable Collamer lens [ICL]; STAAR Surgical, Nidau, Switzerland) for moderate to high myopia. We evaluated 56 eyes of 34 patients with myopic refractive errors of -4.00 to -15.25 diopters (D) who underwent ICL implantation and routine postoperative examinations. Before and 1, 3, and 6 months and 1, 2, and 4 years after surgery, we assessed the safety, efficacy, predictability, stability, and adverse events of the surgery. Mean (SD) logMAR uncorrected and best spectacle-corrected visual acuities were -0.03 (0.23) and -0.21 (0.09), respectively, at 4 years after surgery. The mean (SD) safety and efficacy indexes were 1.19 (0.25) and 0.83 (0.29), respectively. At 4 years, 44 (79%) and 52 (93%) of the eyes were within +/-0.5 and +/-1.0 D, respectively, of the targeted correction. Mean (SD) manifest refraction changes of -0.24 (0.57) D occurred from 1 month to 4 years after surgery. No vision-threatening complications occurred during the observation period. Implantation of ICLs is safe and effective and provides predictable and stable refractive results in the treatment of moderate to high myopia during a 4-year observation period, suggesting its viability as a surgical option for the treatment of such eyes.
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                September 2016
                09 September 2016
                : 95
                : 36
                : e4641
                Affiliations
                [a ]Department of Ophthalmology, the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, P.R. China.
                [b ]Department of Orthopedics, Children's Hospital, College of Medicine, Zhejiang University, Hangzhou, P.R. China.
                Author notes
                []Correspondence: Ye Shen, Department of Ophthalmology, the First Affiliated Hospital, College of Medicine, Zhejiang University, 79 Qingchun Rd, Hangzhou, Zhejiang 310003, P.R. China (e-mail: idrshen@ 123456zju.edu.cn ).
                Article
                04641
                10.1097/MD.0000000000004641
                5023878
                27603356
                7f2ab797-1636-4956-89fc-b7ba3b8856e0
                Copyright © 2016 the Author(s). Published by Wolters Kluwer Health, Inc. All rights reserved.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                : 10 January 2016
                : 28 July 2016
                : 1 August 2016
                Categories
                5800
                Research Article
                Observational Study
                Custom metadata
                TRUE

                central hole,chinese,implantable collamer lens,myopia,phakic intraocular lens

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