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      Refractive outcomes and safety of the implantable collamer lens in young low-to-moderate myopes

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          Abstract

          Purpose

          To evaluate visual and refractive outcomes and safety of implantable collamer lens (ICL) implantation in low-to-moderate myopia.

          Setting

          Private Practice – Dougherty Laser Vision, Westlake Village, CA, USA.

          Methods

          A chart review was performed in 56 (104 eyes) consecutive patients who underwent implantation of the Visian ICL V4 model. Inclusion criteria were age between 21 and 40 years, spherical equivalent between −3.00 D and −10.00 D, and cylinder up to −5 D. Data on visual acuity, refraction, and complications were collected.

          Results

          The mean time to the last postoperative visit was 13.1±14.0 months (range, 2 to 50 months). The mean preoperative spherical equivalent was −6.96±1.60 D and the mean preoperative cylinder was −1.03±0.88 D. The mean preoperative corrected distance visual acuity (CDVA) was 20/20 (range, 20/15 to 20/80) that remained unchanged at last postoperative visit. At the last postoperative visit, the spherical equivalent was −0.08±0.01 D and the cylinder was 0.29±0.71 D. Comparison of postoperative uncorrected distance visual acuity (UCDVA) to preoperative CDVA indicated that 27 eyes (26%) had better postoperative UCDVA and 61 eyes (59%) had UDVA equivalent to the preoperative CDVA. Postoperatively, 4 eyes lost 1 line of CDVA and no eyes lost >1 line of CDVA. There were 32 eyes that gained at least ≥1 of CDVA. There were no intraoperative complications. Postoperatively, 3 patients (6 eyes) had dry eye, and 1 patient complained of nighttime halos in 1 eye. At the last postoperative visit, there were no eyes with lens opacity or glaucoma.

          Conclusion

          ICL implantation for low and moderate myopia up to −10 D in patients up to 40 years of age was safe, accurate, and efficacious. ICL implantation may be a good alternative to laser in situ keratomileusis for young myopes less than −10.00 D.

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          Most cited references17

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          Toric Implantable Collamer Lens for moderate to high myopic astigmatism.

          To assess the efficacy of the Toric Implantable Collamer Lens (ICL) to treat moderate to high myopic astigmatism. Prospective nonrandomized clinical trial. Two hundred ten eyes of 124 patients with between 2.38 and 19.5 diopters (D) of myopia (spherical equivalent [SE]) and 1 to 4 D of astigmatism participating in the United States Food and Drug Administration clinical trial of the Toric ICL. Implantation of the Toric ICL. Uncorrected visual acuity (UCVA), refraction, best spectacle-corrected visual acuity (BSCVA), adverse events, and postoperative complications. At 12 months postoperatively, the proportion of eyes with 20/20 or better UCVA (83.1%) was identical to the proportion of eyes with preoperative 20/20 or better BSCVA (83.1%); 76.5% had postoperative UCVA better than or equal to preoperative BSCVA. The mean manifest refractive cylinder dropped from 1.93 D (+/-0.84) at baseline to 0.51 D (+/-0.48) postoperatively, a 73.6% decrease in astigmatism. Although only 21.0% of eyes had 1-D refractive cylinder preoperatively (none less), 91.4% of cases had or =2 lines of BSCVA after 12 months postoperatively, whereas 18.9% of cases improved by > or =2 lines. A total of 76.4% of cases gained > or =1 lines of BSCVA, whereas only 7.5% of cases lost the equivalent amount. Three ICL removals were performed without significant loss of BSCVA, and 1 clinically significant lens opacity was observed. The results support the efficacy and predictability of Toric ICL implantation to treat moderate to high myopic astigmatism. Important safety concerns were not identified.
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            Visual performance after posterior chamber phakic intraocular lens implantation and wavefront-guided laser in situ keratomileusis for low to moderate myopia.

            To compare postoperative visual function after implantable collamer lens (ICL) implantation and after wavefront-guided laser in situ keratomileusis (LASIK) in eyes with low to moderate myopia.
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              Anterior subcapsular opacities and cataracts 5 years after surgery in the visian implantable collamer lens FDA trial.

              To use the techniques of survival analysis to analyze the incidence of anterior subcapsular opacities (symptomatic and asymptomatic) and clinically significant cataract in the US Food and Drug Administration clinical trial of the Visian Implantable Collamer Lens (ICL). Five hundred twenty-six eyes were followed for an average of 4.7 years; 89% (468 eyes), 73% (384 eyes), and 59% (311 eyes) were seen at 3, 4, and 5 years or later, respectively. Anterior subcapsular opacities were defined as trace or more (> or =0.6 LOCS III opacity). Clinically significant cataract required loss of 2 or more lines of best spectacle-corrected visual acuity (BSCVA), a significant increase in glare symptoms, or cataract extraction. Kaplan-Meier analyses of opacities and cataract were performed. The Kaplan-Meier cumulative probability estimate for anterior subcapsular opacities over 7+ years of follow-up was 7% whereas 31 (5.9%) eyes were actually observed. Anterior subcapsular opacities generally occurred early with 58% seen in the first year, 68% in the first 2 years, and 74% in the first 3 years. The cumulative probability estimate for clinically significant cataracts over the 7+ years of follow-up was 2% whereas 7 (1.3%) were actually observed. The difference between the Kaplan-Meier estimate and the actual observed percentage is due to the fact that the former takes into account the differences in postoperative follow-up time of individual eyes. Preoperative myopia (>12.00 diopters) and patient age (>40 years) were significant factors in the development of cataract. No loss of BSCVA was observed in any eye following cataract extraction. Approximately 6% to 7% of eyes develop anterior subcapsular opacities at 7+ years following ICL implantation but only 1% to 2% progress to clinically significant cataract during the same period, especially very high myopes and older patients. Visual outcome following cataract extraction was good.
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                Clinical Ophthalmology
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove Medical Press
                1177-5467
                1177-5483
                2017
                31 January 2017
                : 11
                : 273-277
                Affiliations
                [1 ]Dougherty Laser Vision, Westlake Village, CA, USA
                [2 ]Jules Stein Eye Institute at the David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
                Author notes
                Correspondence: Paul J Dougherty, Dougherty Laser Vision, 4353 Park Terrace Drive #150, Westlake Village, CA 91361, USA, Tel +1 805 987 5300, Email natasha@ 123456doughertylaservision.com
                Article
                opth-11-273
                10.2147/OPTH.S120427
                5298816
                28203053
                01b776fb-4df2-4c23-b4fc-59b8c756bf13
                © 2017 Dougherty and Priver. 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.

                History
                Categories
                Original Research

                Ophthalmology & Optometry
                icl,low myopia,costa rica,dougherty laser vision
                Ophthalmology & Optometry
                icl, low myopia, costa rica, dougherty laser vision

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