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      Buffering zone of implantable Collamer lens sizing in V4c

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          Abstract

          Background

          The purpose of this study was to identify factors related to the unexpected vault in V4c implantable collamer lens (ICL; STAAR Surgical) implantation.

          Methods

          V4c ICLs were implanted in 43 eyes of 43 patients for the correction of myopia. The implanted V4c ICL sizes were determined individually with our previous V4 ICL sizing nomogram based on the sulcus-to-sulcus diameter (STS), and the V4 ICL sizes were then converted to V4c ICL sizes with a size-converting table. We defined the “normal-sizing group” as having a pre-converted ICL size larger than the STS, and the “under-sizing group” as having a pre-converted ICL size smaller than the STS. Refractive outcomes, safety and parameters related to postoperative vault were compared between the two groups.

          Results

          The value of “actual ICL size – STS” differed significantly between the normal-sizing and under-sizing groups ( p < 0.001), but postoperative vault did not differ significantly ( p = 0.442). The demographics, implanted ICL characteristics, effectiveness indexes, safety indexes, and parameters related to postoperative vault did not differ significantly between the two groups ( p > 0.05). Two patients in the normal-sizing group exhibited over-vaulting; these patients had shallow anterior chambers and were implanted with high-dioptric-power ICLs.

          Conclusions

          The achievement of acceptable vault in both normal-sizing and under-sizing groups indicates the existence of a buffering zone in V4c ICL sizing. The smaller size of V4c ICLs should be considered in patients susceptible to over-vaulting, such as those with shallow anterior chambers and high-dioptric-power ICLs.

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          Most cited references24

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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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            Correlation between preoperative biometry and posterior chamber phakic Visian Implantable Collamer Lens vaulting.

            To evaluate (1) the effect of preoperative biometric factors on vault error and (2) the difference in achieved vault (AV) and expected vault (EV) after Visian Implantable Collamer Lens (ICL) implantation.
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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

                Contributors
                82-2-3410-3548 , tychung@skku.edu
                Journal
                BMC Ophthalmol
                BMC Ophthalmol
                BMC Ophthalmology
                BioMed Central (London )
                1471-2415
                22 December 2017
                22 December 2017
                2017
                : 17
                : 260
                Affiliations
                [1 ]ISNI 0000 0001 2181 989X, GRID grid.264381.a, Department of Ophthalmology, Samsung Medical Center, , Sungkyunkwan University School of Medicine, ; #81 Irwon-ro, Gangnam-gu, Seoul, 06351 South Korea
                [2 ]ISNI 0000 0004 0470 4224, GRID grid.411947.e, Department of Preventive Medicine, , Graduate School, The Catholic University of Korea, ; Seoul, South Korea
                [3 ]Saevit Eye Hospital, Goyang, South Korea
                Article
                663
                10.1186/s12886-017-0663-4
                5741871
                29273016
                b43eef9d-ffcf-4452-bfbd-24295de3ca36
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 4 August 2017
                : 13 December 2017
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2017

                Ophthalmology & Optometry
                implantable collamer lens,postoperative vault,sulcus-to-sulcus diameter

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