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      Three-Year Follow-Up of Posterior Chamber Toric Phakic Intraocular Lens Implantation for Moderate to High Myopic Astigmatism

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          Abstract

          Purpose

          To assess the 3-year clinical outcomes of toric phakic intraocular lens (Visian ICL™; STAAR Surgical) implantation for moderate to high myopic astigmatism.

          Methods

          This retrospective study evaluated fifty eyes of 28 patients who underwent toric ICL implantation for the correction of moderate to high myopic astigmatism and who regularly returned for postoperative examination. Before, and 1, 3, and 6 months after, and 1, 2, and 3 years after surgery, we assessed the safety, efficacy, predictability, stability, and adverse events of the surgery in eyes undergoing toric ICL implantation.

          Results

          The logarithm of the minimal angle of resolution (LogMAR) uncorrected visual acuity and LogMAR best spectacle-corrected visual acuity were –0.10 (corresponding to Snellen equivalents 20/16) ± 0.16 and –0.20 (corresponding to 20/12.5) ± 0.07, 3 years postoperatively, respectively. The safety and efficacy indices were 1.16 ± 0.20 and 0.94 ± 0.28. At 3 year, 82% and 98% of the eyes were within 0.5 and 1.0 D, respectively, of the targeted correction. Manifest refraction changes of –0.15 ± 0.31 D occurred from 1 month to 3 year. No vision-threatening complications occurred during the observation period.

          Conclusions

          On the basis of the clinical results of this study, toric ICL implantation was good in all measures of safety, efficacy, predictability, and stability for the correction of moderate to high myopic astigmatism throughout a 3-year observation period.

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          Most cited references24

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          United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up.

          To report on 3-year postoperative safety and efficacy outcomes with the Myopic Implantable Collamer Lens (ICL). Prospective nonrandomized clinical trial. Five hundred twenty-six eyes of 294 patients with between 3.0 and 20.0 diopters (D) of myopia participating in the United States Food and Drug Administration clinical trial of the ICL for myopia. Implantation of the ICL. Uncorrected visual acuity (VA), refraction, best spectacle-corrected VA (BSCVA), adverse events, operative and postoperative complications, lens opacity analysis, subjective satisfaction, and patient symptoms. At 3 years, 59.3% had 20/20 or better VA, and 94.7% had 20/40 or better uncorrected VA if BSCVA was 20/20 and patients were targeted for emmetropia; 67.5% of patients were within 0.5 D and 88.2% were within 1.0 D of predicted refraction. The mean improvement in BSCVA ranged between 0.5 and 0.6 lines. At 3 years postoperatively, 3 eyes (0.8%) decreased by >or=2 lines of BSCVA, in contrast to 40 eyes (10.8%) that improved by a similar amount. Contrast sensitivity improved postoperatively. Cumulative 3-year corneal endothelial cell loss was under 10%. Early largely asymptomatic, presumably surgically induced anterior subcapsular opacities (trace or greater) were seen in 14 eyes (2.7%), with only 2 being clinically significant. Five eyes (0.9%) of 3 patients developed nuclear opacities of grade >2 at 2 to 3 years postoperatively. Three (0.6%) ICL removals with cataract extraction and IOL implantation have been performed. Only 0.6% reported dissatisfaction; 97.1% of patients reported they would choose ICL implantation again. Incidences of patient symptoms, glare, halos, double vision, night vision problems, and night driving difficulties decreased or remained unchanged after ICL surgery. Three-year results from this standardized, multicenter clinical investigation support the safety, efficacy, and predictability of ICL surgery to treat moderate to high myopic refractive errors.
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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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              U.S. Food and Drug Administration clinical trial of the Implantable Contact Lens for moderate to high myopia.

              (2003)
              To assess the safety and efficacy of the Implantable Contact Lens (ICL) to treat moderate to high myopia. Prospective nonrandomized clinical trial. Five hundred twenty-three eyes of 291 patients with between 3 and 20.0 diopters (D) of myopia participating in the U. S. Food and Drug Administration clinical trial of the ICL for myopia. Implantation of the ICL. Uncorrected visual acuity (UCVA), refraction, best spectacle-corrected visual acuity (BSCVA), adverse events, operative and postoperative complications, lens opacity analysis (Lens Opacity Classification System III), subjective satisfaction, and symptoms. Twelve months postoperatively, 60.1% of patients had a visual acuity of 20/20 or better, and 92.5% had an uncorrected visual acuity of 20/40 or better. Patients averaged a 10.31-line improvement in UCVA, 61.6% of patients were within 0.5 D, and 84.7% were within 1.0 D of predicted refraction. Only one case (0.2%) lost > 2 lines of BSCVA. Gains of 2 or more lines of BSCVA occurred in 55 cases (11.8%) at 6 months and 41 cases (9.6%) at 1 year after ICL surgery. Early and largely asymptomatic, presumably surgically induced anterior subcapsular (AS) opacities were seen in 11 cases (2.1%); an additional early AS opacity (0.2%) was seen because of inadvertent anterior chamber irrigation of preservative-containing solution at surgery. Two (0.4%) late (> or = 1 year postoperatively) AS opacities were observed. Two (0.4%) ICL removals with cataract extraction and intraocular lens implantation have been performed. Patient satisfaction (very/extremely satisfied) was reported by 92.4% of subjects on the subjective questionnaire; only four patients (1.0%) reported dissatisfaction. Slightly more patients reported an improvement at 1 year over baseline values for the following subjective symptoms: quality of vision, glare, double vision, and night driving difficulties. Only a 3% difference between pre-ICL and post-ICL surgery was reported for haloes. The results support the safety, efficacy, and predictability of ICL implantation to treat moderate to high myopia.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2013
                8 February 2013
                : 8
                : 2
                : e56453
                Affiliations
                [1 ]Department of Ophthalmology, University of Kitasato School of Medicine, Kanagawa, Japan
                [2 ]Sanno Hospital, Tokyo, Japan
                Case Western Reserve University, United States of America
                Author notes

                Competing Interests: Dr Shimizu is a consultant to STAAR Surgical. There are no patents, products in development or marketed products to declare. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

                Conceived and designed the experiments: KK KS MK. Performed the experiments: KK KS HK AI MK. Analyzed the data: KK HK AI. Contributed reagents/materials/analysis tools: KK HK AI. Wrote the paper: KK.

                Article
                PONE-D-12-31685
                10.1371/journal.pone.0056453
                3568037
                23409187
                ed2274a8-0781-425e-b2da-8266d01db8bf
                Copyright @ 2013

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 11 October 2012
                : 8 January 2013
                Page count
                Pages: 7
                Funding
                The authors have no current external funding sources for this study.
                Categories
                Research Article
                Biology
                Anatomy and Physiology
                Ocular System
                Ocular Anatomy
                Medicine
                Clinical Research Design
                Observational Studies
                Drugs and Devices
                Medical Devices
                Non-Clinical Medicine
                Health Care Policy
                Health Risk Analysis
                Ophthalmology
                Cataracts and Other Lens Disorders
                Surgery

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                Uncategorized

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