Clinical Efficacy of Periphheral Defocus Versus Single Vision Spectacles in Myopia Progression Control.

<h3>Aim</h3> To determine if ‘Defocus Incorporated Multiple Segments’ (DIMS) spectacle lenses slow childhood myopia progression. <h3>Methods</h3> A 2-year double-masked randomised controlled trial was carried out in 183 Chinese children aged 8–13 years, with myopia between −1.00 and −5.00 D and astigmatism ≤1.50 D. Children were randomly assigned to wear DIMS (n=93) or single vision (SV) spectacle lenses (n=90). DIMS lens incorporated multiple segments with myopic defocus of +3.50 D. Refractive error (cycloplegic autorefraction) and axial length were measured at 6month intervals. <h3>Results</h3> 160 children completed the study, n=79 in the DIMS group and n=81 in the SV group. Average (SE) myopic progressions over 2 years were −0.41±0.06 D in the DIMS group and −0.85±0.08 D in the SV group. Mean (SE) axial elongation was 0.21±0.02 mm and 0.55±0.02 mm in the DIMS and SV groups, respectively. Myopia progressed 52% more slowly for children in the DIMS group compared with those in the SV group (mean difference −0.44±0.09 D, 95% CI −0.73 to −0.37, p&lt;0.0001). Likewise, children in the DIMS group had less axial elongation by 62% than those in the SV group (mean difference 0.34±0.04 mm, 95% CI 0.22 to 0.37, p&lt;0.0001). 21.5% children who wore DIMS lenses had no myopia progression over 2 years, but only 7.4% for those who wore SV lenses. <h3>Conclusions</h3> Daily wear of the DIMS lens significantly retarded myopia progression and axial elongation in myopic children. Our results demonstrated simultaneous clear vision with constant myopic defocus can slow myopia progression. <h3>Trial registration number</h3> NCT02206217.

The aim of this study is to investigate if baseline relative peripheral refraction (RPR) influences the myopia control effects in Chinese myopic children wearing Defocus Incorporated Multiple Segments (DIMS) lenses. Peripheral refraction at 10°, 20°, and 30° nasal (10 N, 20 N, 30 N) and temporal (10 T, 20 T, 30 T) retina were measured at six-month intervals for children who participated in a 2-year randomized controlled trial. The relationship between the baseline peripheral refractions and myopia progression and axial length changes were analysed. A total of 79 children and 81 children in the DIMS and single vision (SV) group were investigated, respectively. In the DIMS group, more baseline myopic RPR spherical equivalent (SE) was associated with more myopic progression (10 N: r = 0.36, p = 0.001; 20 N: r = 0.35, p = 0.001) and greater axial elongation (10 N: r = −0.34, p = 0.001; 20 N: r = −0.29, p = 0.006) after adjusting for co-factors. In the SV group, baseline RPR had association with only myopia progression (10 N: r = 0.37, p = 0.001; 20 N: r = 0.36, p = 0.001; 30 N: r = 0.35, p = 0.002) but not with axial elongation after Bonferroni correction (p > 0.008). No statistically significant relationship was found between temporal retina and myopia progression or axial elongation in both groups. Children with baseline myopic RPR had statistically significant more myopia progression (mean difference around −0.40 D) and more axial elongation (mean difference 0.15 mm) when compared with the children having baseline hyperopic RPR in the DIMS group but not in the SV group. In conclusion, the baseline RPR profile may not influence future myopia progression or axial elongation for the SV lens wearers. However, DIMS lenses slowed down myopia progression and was better in myopia control for the children with baseline hyperopic RPR than the children with myopic RPR. This may partially explain why myopia control effects vary among myopic children. Customised myopic defocus for individuals may optimise myopia control effects, and further research to determine the optimal dosage, with consideration of peripheral retinal profile, is warranted.

AimTo determine if ‘Defocus Incorporated Multiple Segments’ (DIMS) spectacle lenses slow childhood myopia progression.MethodsA 2-year double-masked randomised controlled trial was carried out in 183 Chinese children aged 8–13 years, with...

BackgroundMyopia control interventions, such as defocus incorporated multiple segments (DIMS) spectacle lenses, have been adopted in school-aged children to reduce the prevalence of myopia and its complications. This study aimed to investigate the effect of DIMS spectacle lenses on subfoveal choroidal thickness (SfChT) over a period of two years, as the choroidal response to myopic control is a crucial factor in exploring its potential effect on predicting myopia progression.MethodsThis study involved a secondary analysis of our previous randomized clinical trial. Myopic school-aged children aged 8–13 years were recruited in a two-year study investigating the effect of DIMS spectacle lenses on myopia progression. The treated group received DIMS spectacle lenses (n = 78), while the control group was treated with a pair of single vision (SV) spectacle lenses (n = 80). SfChT was monitored at 1 week, 1, 3, 6, 12, 18 and 24 months post lens wear using spectral-domain optical coherence tomography and a custom made auto-segmentation algorithm utilizing convolutional neural networks.ResultsSfChT increased significantly after one week of DIMS spectacle lens wear compared to those wearing SV spectacle lenses (adjusted mean change relative to baseline ± SEM at one week; DIMS vs. SV, 6.75 ± 1.52 µm vs. − 3.17 ± 1.48 µm; P < 0.0001, general linear model). The thickness of choroid increased to 13.64 ± 2.62 µm after 12 months of DIMS lens wear while the choroid thinned in SV group (− 9.46 ± 2.55 µm). Choroidal changes demonstrated a significant negative association with axial elongation over two years in both the DIMS and SV groups. Choroidal change at three months significantly predicted the changes in AL at 12 months after controlling the effect of age and gender.ConclusionsOur study demonstrated a significant choroidal thickening in response to myopic defocus incorporated in a spectacle lens after one week of lens wear, sustained over the two-year study period. The results suggested that choroidal changes at three months may help predict changes in axial length after one year.Trial registration ClinicalTrials.gov. Myopia control with the multi-segment lens. NCT02206217. Registered 29 July 2014, https://clinicaltrials.gov/ct2/show/study/NCT02206217

Efficacy of Cylindrical Annular Refractive Elements (CARE) Spectacle Lenses in Slowing Myopia Progression Over 2 Years.

PurposeTo compare visual function of myopic children who had worn either defocus incorporated multiple segment (DIMS) spectacle lenses or single vision (SV) spectacle lenses over two years.MethodsWe included 160 Chinese myopic (−1 diopter [D] to −5 D) children aged 8 to 13 years in a randomized clinical trial; they wore either DIMS lenses (DIMS; n = 79) or regular SV spectacles lenses (n = 81) full time for 2 years. Visual function, including high-contrast visual acuity (VA) and low-contrast VA at distance and near, binocular functions, and accommodation, before, during, and after 2 years of spectacle wear were assessed when both groups wore SV corrections. Changes of visual function between the two groups and within groups were compared.ResultsThere were no statistically significant differences in the 2-year visual function changes between DIMS and SV groups (repeated measures analysis of variance with group as factor; P > 0.05). Statistically significant improvement in the best-corrected distance high-contrast VA (P < 0.001) and stereoacuity score (P < 0.001) were found after DIMS lens wear over 2 years. Similar findings were observed after SV spectacle lens wear. For both the DIMS and SV groups, there were statistically significant decreases in accommodative lag, monocular and binocular amplitude of accommodation after two years (P < 0.01), but not in the changes in distance low-contrast VA, near high-contrast VA, near low-contrast VA, or phoria.ConclusionsAlthough changes in some visual function were shown during 2 years of DIMS lens wear, similar changes were found with SV lens wear. Wear of DIMS spectacle lenses for 2 years does not adversely affect major visual function when children return to SV corrections.Translational RelevanceDIMS spectacle lenses did not cause any adverse effects on visual function.

Objective. To evaluate the degree of axial elongation with soft radial refractive gradient (SRRG) contact lenses, orthokeratology (OK), and single vision (SV) spectacle lenses (control) during a period of 1 year before treatment and 2 years after treatment. Methods. This was a prospective, longitudinal, nonrandomized study. The study groups consisted of 30, 29, and 41 children, respectively. The axial length (AL) was measured during 2 years after recruitment and lens fitting. Results. The baseline refractive sphere was correlated significantly (Spearman's Rho (ρ) correlation = 0.542; P < 0.0001) with the amount of myopia progression before baseline. After 2 years, the mean myopia progression values for the SRRG, OK, and SV groups were −0.56 ± 0.51, −0.32 ± 0.53, and −0.98 ± 0.58 diopter, respectively. The results represent reductions in myopic progression of 43% and 67% for the SRRG and OK groups, respectively, compared to the SV group. The AL increased 27% and 38% less in the SRRG and OK groups, respectively compared with the SV group at the 2-year visit (P < 0.05). Axial elongation was not significantly different between SRRG and OK (P = 0.430). Conclusion. The SRRG lens significantly decreased AL elongation compared to the SV control group. The SRRG lens was similarly effective to OK in preventing myopia progression in myopic children and adolescent.

Background Nearsightedness (myopia) causes blurry vision when looking at distant objects. Highly nearsighted people are at greater risk of several vision-threatening problems such as retinal detachments, choroidal atrophy, cataracts and glaucoma. Interventions that have been explored to slow the progression of myopia include bifocal spectacles, cycloplegic drops, intraocular pressure-lowering drugs, muscarinic receptor antagonists and contact lenses. The purpose of this review was to systematically assess the effectiveness of strategies to control progression of myopia in children.

INTRODUCTION: Defocus Incorporated Multiple Segments (DIMS) lens imposes simultaneous myopic defocus for myopia control and has been proven to be effective in controlling myopia progression in children. However, the effectiveness of the DIMS lens may vary between different ethnicity due to different retinal profiles among children. This study aims to determine the effectiveness of DIMS lens in controlling myopia progression among myopic Malay schoolchildren. MATERIALS AND METHODS: This is a randomized control trial and was conducted as a single-site study where forty-two myopic Malay schoolchildren, (mean age of 9.53±1.50 years old) were recruited. The effectiveness of the DIMS lens was measured via changes in spherical equivalent refraction and axial length elongation for 12 months, and findings were compared with children wearing single vision (SV) lens. Data was analysed using repeated analysis of variance (ANOVA), between-within with Bonferroni correction, and p&lt;0.05 indicated a significant difference. RESULTS: After 12 months, 38 subjects completed the study, with 20 subjects in the DIMS group and 18 subjects in the SV group. The DIMS group showed a significantly lower myopia progression; with 0.07±0.10mm increment in axial length elongation and -0.16±0.30D in spherical equivalent refraction increment compared to the SV group. The main effect comparing the changes in axial length elongation and spherical equivalent refraction increment between the DIMS group and the SV group was significant, (F=7.61, p &lt;0.05) and (F=3.23, p&lt;0.05), respectively. CONCLUSIONS: Full time wear of the DIMS lens is significantly effective in slowing myopia progression compared to SV lens in myopic Malay schoolchildren.

PurposeTo compare changes in relative peripheral refraction (RPR) associated with myopia progression in myopic children wearing Defocus Incorporated Multiple Segments (DIMS) lenses and single vision (SV) spectacle lenses over 2 years.MethodsA 2-year double-blind, randomized controlled trial was conducted on 183 myopic children. Subjects were allocated to either wearing DIMS (n = 93) or SV spectacle lenses (n = 90). Peripheral refraction at 10°, 20°, and 30° of the nasal (10N, 20N, 30N) and temporal (10T, 20T, 30T) retinal eccentricities, central refraction, and axial length after cycloplegia were monitored every 6 months.ResultsDIMS group showed symmetrical peripheral myopic shifts between the nasal and temporal retina (comparing myopic shifts between the nasal and temporal retina, the difference between the corresponding eccentricities were nonclinically significance). SV group showed asymmetrical peripheral myopic shifts between the nasal and temporal retina, with more myopic shifts (all P ≤ 0.001) at 10T (−0.32 ± 0.62 diopters [D]), at 20T (−0.69 ± 0.95 D), and 30T (−0.85 ± 1.52 D). No significant changes in RPR spherical equivalent (M) were noted in the DIMS group, whereas significant increases (all P < 0.0001) in hyperopic RPR M were observed at 10N (0.27 ± 0.45 D), 20N (0.75 ± 0.72 D), and 30N (0.98 ± 0.76 D) in the SV group.ConclusionsWearing DIMS lenses resulted in a significantly different peripheral refraction profile and RPR changes, as well as significant myopia control effects when compared with SV lenses. Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.

Defocus Incorporated Soft Contact (DISC) lenses with +2.50 D myopic defocus reduced myopia progression by 25% in a previous randomised clinical trial (RCT). The current study aimed to evaluate if a stronger myopic defocus, +3.50 D with variable myopic defocus (DISC3.5plus), could slow myopia progression compared with single vision (SV) soft contact lenses in a 12-month RCT. Conducted from December 2018 to January 2021, the current RCT randomly assigned myopic children to wear DISC3.5plus (n = 87) or SV (n = 80) lenses. Myopia progression and axial elongation were compared between the two groups. Analyses were performed for both enrolled and completed participants. For all enrolled participants, the DISC3.5plus group had significantly less myopia progression (mean difference: -0.15 ± 0.07 D, p = 0.02) and axial elongation (mean difference: 0.04 ± 0.02 D, p = 0.04) than the SV group at 6 months but not at 12 months (myopia progression: p = 0.11; axial elongation: p = 0.13). For completed participants, the DISC3.5plus group (n = 33) had reduced myopia progression at both 6 months (0.25 ± 0.07 D, p = 0.001) and 12 months (0.19 ± 0.09 D, p = 0.049) compared with the SV group (n = 40), but not in axial elongation (6 months: p = 0.16; 12 months: p = 0.32). In January 2020, the coronavirus pandemic disturbed contact lens-wearing patterns. DISC3.5plus lenses significantly slowed myopia progression and axial elongation compared with SV lenses for all enrolled participants over 6 months. The pandemic hindered longer term efficacy follow-up and sample size; thus, further investigation with more participants is needed to confirm sustained treatment effects.

AimTo evaluate and compare the efficacy of combination treatment using 0.025% atropine and Defocus Incorporated Multiple Segments (DIMS) spectacle lenses to 0.025% atropine and single vision (SV) spectacle lenses in slowing myopia progression in children with myopia.MethodsRandomised controlled trial conducted on children aged 4–16 years with myopia between −1.00D and −6.00D and astigmatism ≤2.00D. Children were randomly allocated into two groups: 0.025% atropine and SV spectacle lenses treatment group (group A), and 0.025% atropine and DIMS spectacle lenses treatment group (group B). Cycloplegic spherical equivalent refraction (SER) and axial length were measured at baseline, 6 and 12 months.Results102 patients completed the 12-month follow-up: n=49 in group A, mean age 9.50±2.78 years and n=53 in group B, mean age 9.90±2.47 years. At 12 months, the mean AL±SD change was 0.18±0.16 mm in group A and 0.07±0.16 mm in group B (mean difference: 0.11, 95% CI: 0.05 to 0.17; p≤0.001). Mean SER±SD progression at 12 months was −0.19±0.42D and −0.09±0.35D in groups A and B, respectively (p=0.13). 39.6% of children in group B had no axial elongation over 12 months compared with 12.2% of the children in group A (p=0.002).ConclusionsCombination treatment with 0.025% atropine and DIMS spectacle lenses is more effective in controlling axial elongation than 0.025% atropine with SV lenses. Although not significant, SER differences between groups were lower in group B. These findings support a potential additive effect of the two treatments.

Novel Lenslet-ARray-Integrated Spectacle Lenses for Myopia Control: A 1-Year Randomized, Double-Masked, Controlled Trial

The Efficacy of Defocus Incorporated Multiple Segments Lenses in Slowing Myopia Progression: Results from Diverse Clinical Circumstances

To compare myopia progression in children randomized to MiSight contact lenses (CLs) versus children corrected with single-vision spectacles (SV) over a 2-year period. Subjects aged 8 to 12 with myopia (-0.75 to -4.00 D sphere) and astigmatism (<-1.00 D cylinder) were assigned to the lens study group (MiSight) or the control group (single vision). Measurements of visual acuity and subjective refraction were taken at 6-month intervals, and axial length, anterior chamber, corneal power, and cycloplegic autorefraction were measured at the baseline, 12-month, and 24-month visits. Eighty-nine subjects were recruited. Forty-fix children were assigned to the MiSight group, and 33 to the single-vision spectacle group. In total, 74 children completed the clinical trial, with the following parameters at the beginning of the study: n = 41 in the MiSight group (age: 11.01 ± 1.23years, spherical equivalent: -2.16 ± 0.94 D, gender: male: 21, female: 20) and n = 33 in the single-vision group (age: 10.12 ± 1.38years, spherical equivalent: -1.75 ± 0.94 D, gender: male: 12, female: 21). After 2years of follow-up, myopia progressed slowly in the MiSight group compared to the control group (0.45 D vs 0.74 D, p < 0.001) and there was less axial elongation in the MiSight group compared to the single-vision group (0.28mm vs 0.44mm, p < 0.001). Therefore, use of MiSight CLs produced lower myopia progression (39.32%) and lower axial growth of the eye (36.04%) at 2years compared to spectacle use. MiSight contact lens wear reduces axial elongation and myopia progression in comparison to distance single-vision spectacles in children. ClinicalTrials.gov Identifier: NCT01917110.