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

      review-article
      Clinical Ophthalmology (Auckland, N.Z.)
      Dove Medical Press
      refractive surgery, Phakic lens, posterior chamber, myopia

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          Abstract

          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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          Most cited references79

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          The relationship between glaucoma and myopia: the Blue Mountains Eye Study.

          To quantify the relationship between myopia and open-angle glaucoma, ocular hypertension (OH), and intraocular pressure (IOP) in a representative older population. Cross-sectional population-based study of 3654 Australians 49 to 97 years of age. Subjects with any myopia (> or =-1.0 diopter [D]) were identified by a standardized subjective refraction and categorized into low myopia (> or =-1.0 D to or =-3.0 D). Glaucoma was diagnosed from characteristic visual field loss, combined with optic disc cupping and rim thinning, without reference to IOP. Ocular hypertension was diagnosed when applanation IOP was greater than 21 mmHg in either eye in the absence of glaucomatous visual field and optic disc changes. General estimating equation models were used to assess associations between eyes with myopia and either glaucoma or OH. Glaucoma was present in 4.2% of eyes with low myopia and 4.4% of eyes with moderate-to-high myopia compared to 1.5% of eyes without myopia. The relationship between glaucoma and myopia was maintained after adjusting for known glaucoma risk factors, odds ratio (OR) of 2.3, and 95% confidence intervals (CI) of 1.3 to 4.1 for low myopia. It was stronger for eyes with moderate-to-high myopia (OR, 3.3; CI, 1.7-6.4). Only a borderline relationship was found with OH, OR of 1.8 (CI, 1.2-2.9) for low myopia, and OR of 0.9 (CI, 0.4-2.0) for moderate-to-high myopia. Mean IOP was approximately 0.5 mmHg higher in myopic eyes compared to nonmyopic eyes. This study has confirmed a strong relationship between myopia and glaucoma. Myopic subjects had a twofold to threefold increased risk of glaucoma compared with that of nonmyopic subjects. The risk was independent of other glaucoma risk factors and IOP.
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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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              Eight-year follow-up of posterior chamber phakic intraocular lens implantation for moderate to high myopia.

              To assess the long-term clinical outcomes of Implantable Collamer Lens (Visian ICL; STAAR Surgical) implantation for moderate to high myopia.
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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
                2016
                09 June 2016
                : 10
                : 1059-1077
                Affiliations
                Mark Packer MD Consulting, Inc., Boulder, CO, USA
                Author notes
                Correspondence: Mark Packer, Mark Packer MD Consulting, Inc., 1400 Bluebell Avenue, Boulder, CO 80302, USA, Tel +1 541 915 0291, Email mark@ 123456markpackerconsulting.com
                Article
                opth-10-1059
                10.2147/OPTH.S111620
                4907705
                27354760
                8084d6c4-e0ba-4eac-9193-f7a5353c5c25
                © 2016 Packer. 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
                Review

                Ophthalmology & Optometry
                refractive surgery,phakic lens,posterior chamber,myopia
                Ophthalmology & Optometry
                refractive surgery, phakic lens, posterior chamber, myopia

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