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      A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control :

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          Abstract

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

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          Most cited references40

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          Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year randomized clinical trial.

          This single-masked randomized clinical trial aimed to evaluate the effectiveness of orthokeratology (ortho-k) for myopic control. A total of 102 eligible subjects, ranging in age from 6 to 10 years, with myopia between 0.50 and 4.00 diopters (D) and astigmatism not more than 1.25D, were randomly assigned to wear ortho-k lenses or single-vision glasses for a period of 2 years. Axial length was measured by intraocular lens calculation by a masked examiner and was performed at the baseline and every 6 months. This study was registered at ClinicalTrials.gov, number NCT00962208. In all, 78 subjects (37 in ortho-k group and 41 in control group) completed the study. The average axial elongation, at the end of 2 years, were 0.36 ± 0.24 and 0.63 ± 0.26 mm in the ortho-k and control groups, respectively, and were significantly slower in the ortho-k group (P 0.54) but was correlated with the initial age of the subjects (P 1.00D per year) were 65% and 13% in younger (age range: 7-8 years) and older (age range: 9-10 years) children, respectively, in the control group and were 20% and 9%, respectively, in the ortho-k group. Five subjects discontinued ortho-k treatment due to adverse events. On average, subjects wearing ortho-k lenses had a slower increase in axial elongation by 43% compared with that of subjects wearing single-vision glasses. Younger children tended to have faster axial elongation and may benefit from early ortho-k treatment. (ClinicalTrials.gov number, NCT00962208.).
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            Prevalence of refractive error in the United States, 1999-2004.

            To describe the prevalence of refractive error in the United States. The 1999-2004 National Health and Nutrition Examination Survey (NHANES) used an autorefractor to obtain refractive error data on a nationally representative sample of the US noninstitutionalized, civilian population 12 years and older. Using data from the eye with a greater absolute spherical equivalent (SphEq) value, we defined clinically important refractive error as follows: hyperopia, SphEq value of 3.0 diopters (D) or greater; myopia, SphEq value of -1.0 D or less; and astigmatism, cylinder of 1.0 D or greater in either eye. Of 14,213 participants 20 years or older who completed the NHANES, refractive error data were obtained for 12,010 (84.5%). The age-standardized prevalences of hyperopia, myopia, and astigmatism were 3.6% (95% confidence interval [CI], 3.2%-4.0%), 33.1% (95% CI, 31.5%-34.7%), and 36.2% (95% CI, 34.9%-37.5%), respectively. Myopia was more prevalent in women (39.9%) than in men (32.6%) (P < .001) among 20- to 39-year-old participants. Persons 60 years or older were less likely to have myopia and more likely to have hyperopia and/or astigmatism than younger persons. Myopia was more common in non-Hispanic whites (35.2%) than in non-Hispanic blacks (28.6%) or Mexican Americans (25.1%) (P < .001 for both). Estimates based on the 1999-2004 NHANES vision examination data indicate that clinically important refractive error affects half of the US population 20 years or older.
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              Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial

              Aims To determine if ‘Defocus Incorporated Soft Contact’ (DISC) lens wear slows childhood myopia progression. Methods A 2-year double-blind randomised controlled trial was carried out in 221 children aged 8–13 years, with myopia between −1.00 and −5.00 Dioptres (D) and astigmatism ≤1.00 D. Subjects were randomly assigned to the DISC (n=111) or single vision (SV; n=110) contact lens group. DISC lenses incorporated concentric rings, which provided an addition of +2.50 D, alternating with the normal distance correction. Refractive error (cycloplegic autorefraction) and axial length were measured at 6-month intervals. Differences between groups were analysed using unpaired t test. Results In total, 128 children completed the study, n=65 in the DISC group and n=63 in the SV group. Myopia progressed 25% more slowly for children in the DISC group compared with those in the control group (0.30 D/year; 95% CI −0.71 to −0.47 vs 0.4 D/year; 95% CI −0.93 to −0.65, p=0.031). Likewise, there was less axial elongation for children in the DISC versus SV groups (0.13 mm/year; 95% CI 0.20 to 0.31 vs 0.18 mm/year; 95% CI 0.30 to 0.43, p=0.009). Treatment effect correlated positively with DISC lens wearing time (r=0.342; p=0.005). Indeed, myopia in children who wore the DISC lenses for five or more hours/day progressed 46% (mean difference=−0.382 D, p=0.001; 95% CI −0.59 to −0.17) less than those in the SV group. Conclusions The daily wearing of DISC lens significantly slowed myopia progression and axial elongation in Hong Kong schoolchildren. The findings demonstrated that simultaneous clear vision with constant myopic defocus can retard myopia progression.
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                Author and article information

                Journal
                Optometry and Vision Science
                Optometry and Vision Science
                Ovid Technologies (Wolters Kluwer Health)
                1040-5488
                2019
                August 2019
                : 96
                : 8
                : 556-567
                Article
                10.1097/OPX.0000000000001410
                31343513
                1b2c5785-414f-48d5-91a2-dd5d80eab89a
                © 2019
                History

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