PurposeWe aimed to determine myopia control efficacy with novel contact lenses (CL) that (1) reduced both central and peripheral defocus, and (2) provided extended depth of focus with better global retinal image quality for points on, and anterior to, the retina and degraded for points posterior to the retina.MethodsChildren (n = 508, 8–13 years) with cycloplegic spherical equivalent (SE) −0.75 to −3.50D were enrolled in a prospective, double blind trial and randomised to one of five groups: (1) single vision, silicone hydrogel (SH) CL; (2) two groups wearing SH CL that imposed myopic defocus across peripheral and central retina (test CL I and II; +1.00D centrally and +2.50 and +1.50 for CL I and II at 3 mm semi‐chord respectively); and (3) two groups wearing extended depth of focus (EDOF) hydrogel CL incorporating higher order aberrations to modulate retinal image quality (test CL III and IV; extended depth of focus of up to +1.75D and +2.50D respectively). Cycloplegic autorefraction and axial length (AL) measurements were conducted at six monthly intervals. Compliance to lens wear was assessed with a diary and collected at each visit. Additionally, subjective responses to various aspects of lens wear were assessed. The trial commenced in February 2014 and was terminated in January 2017 due to site closure. Myopia progression over time between groups was compared using linear mixed models and where needed post hoc analysis with Bonferroni corrections conducted.ResultsMyopia progressed with control CL −1.12 ± 0.51D/0.58 ± 0.27 mm for SE/AL at 24 months. In comparison, all test CL had reduced progression with SE/AL ranging from −0.78D to −0.87D/0.41–0.46 mm at 24 months (AL: p < 0.05 for all test CL; SE p < 0.05 for test CL III and IV) and represented a reduction in axial length elongation of about 22% to 32% and reduction in spherical equivalent of 24% to 32%. With test CL, a greater slowing ranging from 26% to 43% was observed in compliant wearers (≥6 days per week; Control CL: −0.64D/0.30 mm and −1.14D/0.58 mm vs test CL: −0.42D to −0.47D/0.12–0.18 mm and −0.70 to −0.81D/0.19–0.25 mm at 12 and 24 months respectively).ConclusionsContact lenses that either imposed myopic defocus at the retina or modulated retinal image quality resulted in a slower progression of myopia with greater efficacy seen in compliant wearers. Importantly, there was no difference in the myopia control provided by either of these strategies.
PurposeTo develop age-specific and gender-specific reference percentile charts for axial length (AL) and AL/corneal radius of curvature (AL/CR) and, to use percentiles to determine probability of myopia and estimate refractive error (RE).MethodsAnalysis of AL, cycloplegic RE and CR of 14 127 Chinese participants aged 4–18 years from 3 studies. AL and AL/CR percentiles estimated using Lambda-Mu-Sigma method and compared for agreement using intraclass correlation (ICC). Logistic regression was used to model risk of myopia based on age, gender, AL and AL/CR percentiles. Accuracy of AL progression and RE estimated using percentiles was validated using an independent sample of 5742 eyes of children aged 7–10 years.ResultsAge-specific and gender-specific AL and AL/CR (3rd, 5th, 10th, 25th, 50th, 75th, 90th and 95th) percentiles are presented. Concordance between AL and AL/CR percentiles improved with age (0.13 at 4 years to >0.75 from 13 years) and a year-to-year change was observed for all except <10th percentile from 15 years. Increasing age, AL and AL/CR was associated with a more myopic RE (r2=0.45,0.70 and 0.83, respectively). The sensitivity and specificity of the model to estimate probability of myopia was 86.0% and 84.5%, respectively. Estimation of 1-year change in AL using percentiles correlated highly with actual AL (ICC=0.98). Concordance of estimated to actual RE was high (ICC=0.80) and within ±0.50D and ±1.0D of actual RE for 47.4% and 78.9% of eyes, respectively.ConclusionAge-specific and gender-specific AL and AL/CR percentiles provide reference data, aid in identifying and monitoring individuals at risk of myopia and have utility in screening for myopia. AL/CR percentiles were more accurate in estimating probability of myopia in younger children.
To determine the efficacy of two myopia control contact lenses (CL) compared with a single-vision (SV) CL.Methods: Ninety-five Chinese children with myopia, aged 7-13 years in a 1-year prospective, randomised, contralateral, cross-over clinical trial with 3 groups; bilateral SVCL (Group I); randomised, contralateral wear of an extended depth of focus (EDOF) CL and SVCL (Group II) and MiSight® CL and SVCL (Group III). In Groups II and III, CL were crossed over at the 6-month point (Stage 1) and worn for a further 6 months (Stage 2). Group I wore SVCL during both stages. At baseline and the end of each stage, cycloplegic spherical equivalent refractive error (SE) and axial length (AL) were measured. Six-monthly ΔSE/ΔAL across groups was analysed using a linear mixed model (CL type, stage, eye and eye* stage included as factors). Intragroup paired differences between eyes were determined. Results:In Group I, mean (SD) ΔSE/ΔAL with SVCL was −0.41 (0.28) D/0.13 (0.09) mm and −0.25 (0.27) D/0.16 (0.09) mm for stages 1 and 2, with a mean paired difference between eyes of 0.01 D/0.01 mm and 0.05 D/−0.01 mm, respectively. ΔSE/ΔAL with SVCL was similar across Groups I to III (Stage 1: p = 0.89/0.44, Stage 2: p = 0.70/ 0.64). In Groups II and III, ΔSE/ΔAL was lower with the EDOF and MiSight® CL than the contralateral SVCL in 68% to 94% of participants, and adjusted 6-month ΔSE/ ΔAL with EDOF was similar to MiSight® (p = 0.49/0.56 for ΔSE/ΔAL, respectively). Discontinuations across the three groups were high, but not different between the groups (33.3%, 48.4% and 50% for Groups I to III, respectively [p = 0.19]) and most discontinuations occurred immediately after baseline.Conclusions: Extended depth of focus and MiSight® CL demonstrated similar efficacy in slowing myopia. When switched from a myopia control CL to SVCL, myopia progression was similar to that observed with age-matched wearers in SVCL and not suggestive of rebound.K E Y W O R D S contact lenses, contralateral, cross-over, dual focus, extended depth of focus, myopia progression
ObjectivesTo report on: (a) overall myopia and high myopia prevalence, and (b) the impact of education on the spherical equivalent refractive error in children across Shanghai.DesignCross-sectional study.SettingAcross all 17 districts of Shanghai.Participants910 245 children aged 4–14 years from a school-based survey conducted between 2012 and 2013.Main outcome measuresData of children with non-cycloplegic autorefraction, visual acuity assessment and questionnaire were analysed (67%, n=6 06 476). Prevalence of myopia (≤−1.0 D) and high myopia (≤−5.0 D) was determined. We used a regression discontinuity design to determine the impact of school entry cut-off date (1 September) by comparing refractive errors at each age, for children born pre-September to post-1 September, and performed a multivariate analysis to explore risk factors associated with myopia. Data analysis was performed in 2017–2018.ResultsPrevalence rates of myopia and high myopia were 32.9% (95% CI: 32.8% to 33.1%) and 4.2% (95% CI: 4.1% to 4.2%), respectively. From 6 years of age onwards, children born pre-September were more myopic compared with those born post-1 September (ahead in school by 1 year, discontinuity at 6 years: −0.19 D (95% CI: −0.09 to −0.30 D); 14 years: −0.67 D (95% CI: −0.21 to −1.14 D)).ConclusionsOur findings suggest that myopia is associated with education, that is primarily focused on near-based activities. Efforts to reduce the burden should be directed to public awareness, reform of education and health systems.
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