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      Center-for-Near Extended-Depth-of-Focus Soft Contact Lens for Myopia Control in Children: 1-Year Results of a Randomized Controlled Trial


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          This study aimed to assess the safety and efficacy of a novel extended-depth-of-focus (EDOF) soft contact lens for myopia control in children.


          A prospective, multicenter, randomized, double-masked, placebo-controlled, contralateral-eye comparison clinical trial was conducted in 72 children (40 male and 32 female) aged 9 to 14 years, with each eye randomly selected to wear either an experimental EDOF contact lens or a single-vision control lens at least 8 h per day, 5 days a week, for 52 weeks. Each contact lens was worn and then replaced daily. Measurements including best-corrected visual acuity, spherical equivalent refractive error (SER), axial length (AXL), and keratometry were performed at weeks 1, 4, and 13, and every 13 weeks thereafter for 52 weeks. The primary outcome measure was the change in SER, measured using cycloplegic auto-refraction. The secondary outcome measure was the change in AXL.


          At week 52, the mean change in SER was significantly lower with the experimental lens (−0.70 ± 0.49 D) than with the control lens (−0.88 ± 0.51 D; P < .001). The mean AXL elongation was significantly lower with the experimental lens (0.34 ± 0.19 mm) than with the control lens (0.38 ± 0.19 mm; P < .001). The EDOF lens reduced AXL and myopia progression by 10.5% and 20.5%, respectively. The change in SER, but no AXL, was significantly associated with EDOF lens wear in adjusted multivariate regression analysis. Reported adverse events did not differ significantly between the two lens types.


          The results of this 1-year clinical trial demonstrate that the experimental EDOF soft contact lens slows myopia progression and reduces AXL elongation in children compared with a single-vision contact lens. (This study was retrospectively registered with ClinicalTrials.gov; identifier: NCT04238897; date of registration: January 23, 2020.)

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          Most cited references37

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          Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050.

          Myopia is a common cause of vision loss, with uncorrected myopia the leading cause of distance vision impairment globally. Individual studies show variations in the prevalence of myopia and high myopia between regions and ethnic groups, and there continues to be uncertainty regarding increasing prevalence of myopia.
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            Myopia and associated pathological complications.

            Besides the direct economic and social burden of myopia, associated ocular complications may lead to substantial visual loss. In several population and clinic-based cohorts, case-control and cross-sectional studies, higher risks of posterior subcapsular cataract, cortical and nuclear cataract in myopic patients were reported. Patients with high myopia (spherical equivalent at least -6.0 D) are more susceptible to ocular abnormalities. The prevalent risks of glaucoma were higher in myopic adults, and risks of chorioretinal abnormalities such as retinal detachment, chorioretinal atrophy and lacquer cracks increased with severity of myopia and greater axial length. Myopic adults were more likely to have tilted, rotated, and larger discs as well as other optic disc abnormalities. Often, these studies support possible associations between myopia and specific ocular complications, but we cannot infer causality because of limitations in study methodology. The detection and treatment of possible pathological ocular complications is essential in the management of high myopia. The ocular risks associated with myopia should not be underestimated and there is a public health need to prevent the onset or progression of myopia.
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              A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control

              Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years.

                Author and article information

                lucia_tsai@yahoo.com.tw , 018224@ntuh.gov.tw
                Ophthalmol Ther
                Ophthalmol Ther
                Ophthalmology and Therapy
                Springer Healthcare (Cheshire )
                23 June 2022
                23 June 2022
                August 2022
                : 11
                : 4
                : 1577-1588
                [1 ]GRID grid.481324.8, ISNI 0000 0004 0404 6823, Department of Ophthalmology, , Taipei Tzu Chi Hospital, The Buddhist Tzu Chi Medical Foundation, ; Taipei, Taiwan (R.O.C.)
                [2 ]GRID grid.411824.a, ISNI 0000 0004 0622 7222, School of Medicine, , Tzu Chi University, ; Hua-Liang, Taiwan (R.O.C.)
                [3 ]GRID grid.19188.39, ISNI 0000 0004 0546 0241, Department of Ophthalmology, National Taiwan University Hospital, College of Medicine, , National Taiwan University, ; 12F, No 7, Zhongshan S. Rd., Zhongzheng Dist., Taipei, 10002 Taiwan (R.O.C.)
                Author information
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                : 6 May 2022
                : 31 May 2022
                Funded by: FundRef http://dx.doi.org/10.13039/501100005762, National Taiwan University Hospital;
                Funded by: App Vision Care Co, Ltd
                Award ID: MQ2432
                Award ID: 03-FS05-33
                Original Research
                Custom metadata
                © The Author(s) 2022

                axial length,children,extended depth of focus,myopia control,soft contact lens


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