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      Contralateral eye comparison of the long‐term visual quality and stability between implantable collamer lens and laser refractive surgery for myopia

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          Abstract

          Purpose

          To investigate the long‐term visual quality and stability of implantable collamer lens ( ICL) and laser refractive surgery ( LRS) for myopia.

          Methods

          This study comprised 52 eyes of 26 high‐myopia anisometropia patients who were suitable for surgical treatment. In each patient, the higher‐myopia eye was implanted with ICL and the lower‐myopia eye was treated with LRS. The patients were followed for 3 years. During that time period, uncorrected ( UDVA) and corrected distance visual acuity ( CDVA), refraction, wavefront aberration and visual quality were evaluated.

          Results

          The spherical equivalent refractive error changed from −14.11 ± 3.39 D preoperatively to −1.27 ± 1.05 D 3 years after ICL implantation and from −8.75 ± 2.76 D to −1.12 ± 1.30 D after LRS. The changes in refractive error from 1 month to 3 years were −0.52 and −0.77 D for the ICL and LRS groups, respectively. The safety indices (postoperative CDVA/preoperative CDVA) were 1.84 ± 1.00 and 1.32 ± 0.40, and the efficacy indices (postoperative UDVA/preoperative CDVA) were 1.40 ± 1.10 and 1.11 ± 0.44, respectively. The postoperative coma, spherical and total higher‐order aberrations in the ICL group were lower than those in the LRS group.

          Conclusion

          Both ICL implantation and LRS are safe and effective procedures for myopia with suitable indications, but ICL implantation is more stable. Fewer induced aberrations are gained after ICL implantation.

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          Most cited references32

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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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              • Abstract: found
              • Article: not found

              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
                doctxiaoyingwang@163.com
                doctzhouxingtao@163.com
                Journal
                Acta Ophthalmol
                Acta Ophthalmol
                10.1111/(ISSN)1755-3768
                AOS
                Acta Ophthalmologica
                John Wiley and Sons Inc. (Hoboken )
                1755-375X
                1755-3768
                05 September 2018
                May 2019
                : 97
                : 3 ( doiID: 10.1111/aos.2019.97.issue-3 )
                : e471-e478
                Affiliations
                [ 1 ] Department of Ophthalmology Eye and ENT Hospital of Fudan University Shanghai China
                [ 2 ] Department of Ophthalmology NHC Key Laboratory of Myopia Fudan University Shanghai China
                [ 3 ] Department of Ophthalmology Xi'an No. 4 Hospital of Xi'an Jiao Tong University Xi'an China
                [ 4 ] Department of Ophthalmology Jing'an District Centre Hospital of Fudan University Shanghai China
                Author notes
                [*] [* ] Correspondence:

                Xiaoying Wang, MD, PhD and Xingtao Zhou, MD, PhD

                Department of Ophthalmology

                Eye and ENT Hospital of Fudan University

                No. 19 BaoQing Road

                XuHui District

                Shanghai 200031

                China

                Tel/Fax: +86‐021‐64377134

                Emails: doctxiaoyingwang@ 123456163.com (XW); doctzhouxingtao@ 123456163.com (XZ)

                [†]

                These authors contributed equally to this work.

                Author information
                http://orcid.org/0000-0001-5419-6318
                http://orcid.org/0000-0002-3465-1579
                Article
                AOS13846
                10.1111/aos.13846
                6585688
                30187653
                07f1a8d9-10b4-4bc8-8d09-b3c83e92ace7
                © 2018 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 22 January 2018
                : 14 May 2018
                Page count
                Figures: 4, Tables: 4, Pages: 8, Words: 5974
                Funding
                Funded by: Health and Family Planning Committee of Pudong New District of Shanghai
                Award ID: PW2014D‐1
                Funded by: Shanghai Shenkang Hospital Development Center
                Award ID: SHDC12016207
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                aos13846
                May 2019
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.4 mode:remove_FC converted:20.06.2019

                Ophthalmology & Optometry
                high myopia,higher‐order aberration,implantable collamer lens,laser refractive surgery,visual quality

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