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      Long-term evaluation of anterior lens density after implantable collamer lens V4c implantation in patients with myopia over 40 years old

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          Abstract

          Purpose

          To investigate the long-term safety and efficacy of implantable collamer lens (ICL) V4c implantation and changes in the anterior lens density (ALD) in patients with myopia ≥40 years of age.

          Methods

          This prospective study included 104 eyes of 52 patients >40 years of age before ICL V4c implantation. Spherical equivalent (SE), uncorrected distance visual acuity, corrected distance visual acuity (CDVA), intraocular pressure, endothelial cell density, anterior chamber depth, anterior chamber volume and anterior chamber angle preoperatively, at 1 and 3 months, and at 3 years postoperatively were recorded. Pentacam HR was used to analyse ALD changes at a depth of 0.5, 1.0 and 1.5 mm within a 3 mm diameter range around the pupil’s centre.

          Results

          The overall follow-up was uneventful at 42±7.1 months; the safety index at last follow-up was 1.26±0.35 and the efficacy index was 0.91±0.41. No eye lost the Snellen line of CDVA, 76% of the eyes had an increase in CDVA for ≥1 line and 62% had an SE within ±0.50 dioptre. The increase in ALD at 0.5, 1 and 1.5 mm was 16.52%±10.46%, 16.72%±9.85% and 17.28%±11.93%, respectively. Preoperative, 1-month and 3-month postoperative ALDs showed correlations with SE and age, and ALD at last follow-up was correlated only with age. There was no correlation between ALD and any other parameters.

          Conclusion

          ICL V4c shows long-term safety and efficacy in people ≥40 years of age. ALD increased in such patients, which may be related to age and SE.

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          Most cited references20

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          Central corneal endothelial cell changes over a ten-year period.

          To obtain longitudinal data to estimate long-term morphometric changes in normal human corneal endothelia. Ten years after an initial study, the authors rephotographed the central corneal endothelium of 52 normal subjects with the same contact specular microscope. The findings for the 10 subjects younger than 18 years of age at the initial examination were considered separately. For the remaining 42 adult subjects, the time between examinations averaged 10.6 +/- 0.2 years (range, 10.1 to 11 years). At the recent examination, these subjects' ages averaged 59.5 +/- 16.8 years (range, 30 to 84 years). Outlines of 100 cells for each cornea were digitized. For the 42 adult subjects, the mean endothelial cell density decreased during the 10.6-year interval from 2715 +/- 301 cells/mm2 to 2539 +/- 284 cells/mm2 (P < 0.001). The calculated exponential cell loss rate over this interval was 0.6% +/- 0.5% per year. There was no statistically significant correlation between cell loss rate and age. During the 10.6-year interval, the coefficient of variation of cell area increased from 0.26 +/- 0.05 to 0.29 +/- 0.06 (P < 0.001), and the percentage of hexagonal cells decreased from 67% +/- 8% to 64% +/- 6% (P = 0.003). For the 10 subjects 5 to 15 years of age at the initial examination, the exponential cell loss rate was 1.1% +/- 0.8% per year. Human central endothelial cell density decreases at an average rate of approximately 0.6% per year in normal corneas throughout adult life, with gradual increases in polymegethism and pleomorphism.
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            Meta-analysis and review: effectiveness, safety, and central port design of the intraocular collamer lens

            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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              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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                Author and article information

                Journal
                Br J Ophthalmol
                Br J Ophthalmol
                bjophthalmol
                bjo
                The British Journal of Ophthalmology
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0007-1161
                1468-2079
                November 2022
                28 June 2021
                : 106
                : 11
                : 1508-1513
                Affiliations
                [1 ] departmentDepartment of Ophthalmology and Optometry , Fudan University Eye Ear Nose and Throat Hospital , Shanghai, China
                [2 ] departmentKey Laboratory of Myopia , Chinese Academy of Medical Sciences , Shanghai, China
                [3 ] Shanghai Research Center of Ophthalmology and Optometry , Shanghai, China
                Author notes
                [Correspondence to ] Dr Xingtao Zhou, Department of Ophthalmology and Optometry, Fudan University Eye Ear Nose and Throat Hospital, Shanghai, China; doctzhouxingtao@ 123456163.com

                YY and JZ are joint first authors.

                Author information
                http://orcid.org/0000-0001-5419-6318
                http://orcid.org/0000-0002-3465-1579
                Article
                bjophthalmol-2021-319205
                10.1136/bjophthalmol-2021-319205
                9606511
                34183326
                cb78c3eb-e92f-4560-a799-28b54c1d7d7d
                © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 02 March 2021
                : 28 April 2021
                Funding
                Funded by: Project of Shanghai Science and Technology;
                Award ID: 20410710100
                Funded by: Joint research project;
                Award ID: SHDC12018103
                Funded by: Project of Shanghai Xuhui District Science and Technology;
                Award ID: 2020-015
                Funded by: FundRef http://dx.doi.org/10.13039/501100001809, National Natural Science Foundation of China;
                Award ID: 81770955
                Funded by: Clinical Research Plan of SHDC;
                Award ID: SHDC2020CR1043B
                Categories
                Clinical Science
                1506
                Custom metadata
                unlocked

                Ophthalmology & Optometry
                treatment surgery,imaging,posterior chamber,lens and zonules
                Ophthalmology & Optometry
                treatment surgery, imaging, posterior chamber, lens and zonules

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