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      Artiflex foldable lens for myopia correction results of 10 years of follow-up

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          Abstract

          The aim of this study was to evaluate the long-term efficacy and safety of the Artiflex® lens implant and to follow the evolution of the number of corneal endothelial cells over time. It was a retrospective study of an observational case series of patients who underwent surgery at “The INVISION Ophthalmic Hospital” (Almería, Spain) in 2007 and who were followed for 10 years. Setting : Clinical practice. Study population included 53 eyes of 30 patients who underwent an Artiflex® lens implant for the correction of myopia from −4 to −14 D. Each patient included in this study had stable myopia for at least 2 years and a contraindication for corneal refractive surgery. The efficacy index was defined as the quotient between uncorrected distance visual acuity postoperative and best-corrected distance visual acuity (BCDVA) preoperative. The safety index was calculated as the quotient between BCDVA postop and BCDVA preop. The average efficacy and safety indices of the lenses implanted were 1.1 (SD 0.30) and 1.06 (SD 0.2) at 10 years of follow-up. In this period of time there has been a loss of 12% of the corneal endothelial cells. The postoperative complications were pigment dispersion in four eyes (7%) of four patients and decentration of phakic intraocular lens in two eyes (4%) of another two patients. The Artiflex® foldable phakic lens could be a safe and effective long-term alternative for myopic patients in whom laser surgery was contraindicated.

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          Most cited references23

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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.
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            Phakic intraocular lenses part 1: historical overview, current models, selection criteria, and surgical techniques.

            In this 2-part overview, the current status of phakic intraocular lens (pIOL) surgery to correct refractive errors is reviewed. Three types of pIOLs, categorized by their intraocular position, are included: angle-supported anterior chamber, iris-fixated anterior chamber, and posterior chamber (usually fixated in the ciliary sulcus). Part 1 reviews the main models of each pIOL type, the selection criteria, and the surgical techniques, with emphasis on currently available pIOLs. Bioptics, adjustable refractive surgery, and enhancements are addressed, and applications of the new anterior segment imaging techniques are reviewed. Copyright © 2010 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.
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              Foldable Artiflex phakic intraocular lens for the correction of myopia: two-year follow-up results of a prospective European multicenter study.

              To evaluate the safety, efficacy, predictability, stability, and complications of the foldable Artiflex iris-fixated intraocular lens (Ophtec BV, Groningen, The Netherlands) for the correction of myopia in phakic eyes. Prospective, nonrandomized, open-label, multicenter trial. Two hundred ninety eyes of 191 patients aged 18 to 60 years with average spherical equivalent of -7.33+/-2.60 diopters (D; range, -12.63 to -1.5 D) were analyzed. All eyes underwent implantation of the foldable iris-fixated Artiflex phakic intraocular lens (PIOL) with an optic zone of 6 mm. The follow-up was 2 years. Phakic intraocular lenses were implanted in powers ranging from -2.0 to -12.0 D. The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), refraction, and endothelial cell count. After 2 years, a UCVA of 20/40 or better was observed in 97.2% of eyes. The BSCVA was 20/40 or better in all eyes. A gain of 1 line or more of BSCVA was found in 49.9% of eyes, and 0.8% lost 2 or more lines. The mean endothelial cell change was -0.05%, 1.79%, and -1.07% at 6 months, 1 year, and 2 years, respectively. Complications were comparable with complications that have been reported previously of the Artisan PIOL, the only exception being a higher incidence of iris pigment precipitates (4.8% at 2 years after surgery). After 2 years of follow-up, the implantation of the foldable iris-fixated Artiflex intraocular lens proved to be effective and predictable for the correction of myopia in phakic eyes.
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                Author and article information

                Journal
                Eye
                Eye
                Springer Nature
                0950-222X
                1476-5454
                April 29 2019
                Article
                10.1038/s41433-019-0446-7
                7002379
                31036878
                32891b82-0461-440a-bd3b-b402a9c398c6
                © 2019

                http://www.springer.com/tdm

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