Two-year results of Lenslet-ARray-Integrated spectacle lenses for myopia control in children

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

This study aimed to examine the effect of Defocus Incorporated Multiple Segments (DIMS) lenses on myopia progression and axial elongation in a clinical population. A retrospective study was conducted using clinical data from 489 and 156 patients aged 3 to 17 years old who were prescribed DIMS and single vision (SV) lenses, respectively at the Optometry Clinic of The Hong Kong Polytechnic University between July 2018 and August 2019. The study included patients with previous myopia control interventions. The changes in spherical equivalent refraction (SER) and axial length (AL) were measured and normalized to annual changes. The correlation between age at baseline and annual change in AL was also examined. The total change in SER and AL after DIMS were -0.94 ± 0.79D and 0.55 ± 0.40 mm, respectively with an average wearing period of 31.98 ± 9.97 months. The normalized annual changes in SER and AL in DIMS wearers were significantly smaller than those in SV wearers (DIMS; SER change vs. AL changes; -0.38 ± 0.32D vs. 0.22 ± 0.16 mm. SV; -0.45 ± 0.41D vs. 0.29 ± 0.20 mm, p < 0.05). Patients with a history of myopia control had greater myopia progression after wearing DIMS lenses. There was a significant negative correlation between age at baseline and annual change in AL (correlation coefficient, r = -0.61, p < 0.001), suggesting that myopia progression was faster in children with a younger age of onset. A small proportion of patients (2.7%) experienced a clinically significant axial shortening (total change in AL:-0.13 ± 0.07 mm) after wearing DIMS lenses more than 2 years. The study demonstrated that DIMS lenses could retard axial elongation, with the effect sustained with increased duration of lens wear. However, patients with previous myopia control experienced greater myopia progression after wearing DIMS lenses. The study also highlighted the potential for axial length shortening in a small proportion of patients after the DIMS lens wear. These findings underscore the importance of adherence to intervention in achieving optimal treatment efficacy. Further research is needed to understand the mechanisms underlying these effects and to optimize the use of optical interventions in myopia control.

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.

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.

Effectiveness of orthokeratology and myopia control spectacles in a real-world setting in China

Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years. The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia. Myopic children (spherical equivalent refraction, -0.75 to -4.00 D; astigmatism, <1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight 1-day contact lens (test) or Proclear 1-day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length. Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was -0.73 D (59%) less in the test group than in the control group (-0.51 ± 0.64 vs. -1.24 ± 0.61 D, P < .001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P < .001). Changes in spherical equivalent refraction and axial length were highly correlated (r = -0.90, P < .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits. Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.

Reducing myopia progression can reduce the risk of associated ocular pathologies. To evaluate whether spectacle lenses with higher lenslet asphericity have a higher myopia control efficacy throughout 2 years. This double-masked randomized clinical trial was conducted between July 2018 and October 2020 at the Eye Hospital of Wenzhou Medical University in Wenzhou, China. Children aged 8 to 13 years with a cycloplegic spherical equivalent refraction (SER) of -0.75 D to -4.75 D and astigmatism with less than -1.50 D were recruited. A data and safety monitoring committee reviewed findings from a planned interim analysis in 2019. Participants were randomly assigned in a 1:1:1 ratio to receive spectacle lenses with highly aspherical lenslets (HAL), spectacle lenses with slightly aspherical lenslets (SAL), or single-vision spectacle lenses (SVL). Two-year changes in SER and axial length and their differences between groups. Of 157 participants who completed each visit (mean [SD] age, 10.4 [1.2] years), 54 were analyzed in the HAL group, 53 in the SAL group, and 50 in the SVL group. Mean (SE) 2-year myopia progression in the SVL group was 1.46 (0.09) D. Compared with SVL, the mean (SE) change in SER was less for HAL (by 0.80 [0.11] D) and SAL (by 0.42 [0.11] D; P ≤ .001). The mean (SE) increase in axial length was 0.69 (0.04) mm for SVL. Compared with SVL, increase in axial length was slowed by a mean (SE) of 0.35 (0.05) mm for HAL and 0.18 (0.05) mm for SAL (P ≤ .001). Compared with SVL, for children who wore HAL at least 12 hours every day, the mean (SE) change in SER was slowed by 0.99 (0.12) D, and increase in axial length slowed by 0.41 (0.05) mm. In this study, HAL and SAL reduced the rate of myopia progression and axial elongation throughout 2 years, with higher efficacy for HAL. Longer wearing hours resulted in better myopia control efficacy for HAL. Chinese Clinical Trial Registry Identifier: ChiCTR1800017683.

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.

Significance. Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years.Purpose. The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia.Methods. Myopic children (spherical equivalent refraction, −0.75 to −4.00 D; astigmatism, &lt; 1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight®1 day contact lens (test) or Proclear®1 day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length.Results. Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was −0.73 D (59%) less in the test group than in the control group (−0.51 ± 0.64 vs. –1.24 ± 0.61 D, P &lt; 0.001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P &lt; 0.001). Changes in spherical equivalent refraction and axial length were highly correlated (r = −0.90, P &lt; .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits.Conclusions. Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.

The aim of this study was to investigate the effect of individualized ocular refraction customized (IORC) spectacle lenses with different actual amounts of peripheral myopic defocus (MD) on myopia control over 1 year. These lenses compensate for the original peripheral refraction via the free-form surface on the back of the lens. This 1-year, double-masked randomised clinical trial included 184 myopic schoolchildren aged 8-12 years. Participants were randomised to receive IORC lenses with high (IORC-H group, +4.50 D), medium (IORC-M group, +3.50 D) or low (IORC-L group, +2.50 D) MD or single-vision (SV) lenses. The spherical equivalent refractive error (SER) and axial length (AL) were measured at baseline and 6-monthly intervals. After 1 year, the mean (SD) changes in SER were -0.18 (0.37), -0.36 (0.37), -0.52 (0.39) and -0.60 (0.42) D for the IORC-H, IORC-M, IORC-L and SV groups, respectively. Compared with the SV group, the effects of slowing myopia progression were 70%, 40% and 13% for the IORC-H (difference of 0.47 D, p < 0.001), IORC-M (difference of 0.32 D, p = 0.001) and IORC-L (difference of 0.15 D, p > 0.05) groups, respectively. The mean (SD) changes in AL were 0.12 (0.16), 0.23 (0.17), 0.29 (0.17) and 0.36 (0.17) mm for the IORC-H, IORC-M, IORC-L and SV groups, respectively. The axial elongation was 67%, 36% and 19% lower in the IORC-H (difference of 0.25 mm, p < 0.001), IORC-M (difference of 0.15 mm, p < 0.001) and IORC-L (difference of 0.10 mm, p = 0.04) groups, respectively, compared with the SV group. The IORC-H group exhibited significantly less axial elongation than the IORC-M and IORC-L groups (p = 0.01 and p < 0.001, respectively). Compared with the IORC-M and IORC-L lenses, the IORC-H lens was found to have superior efficacy in inhibiting myopic progression and slowing eye growth in schoolchildren, with better myopia control efficacy in younger children.

Purpose: To assess the efficacy of the Defocus Incorporated Multiple Segments (DIMS) spectacle lens for myopia control and its impact on vision-related quality of life in Chinese children over a 1-year period. Methods: This randomized double-blind prospective controlled clinical trial enrolled 176 myopic subjects aged between seven and 14 years who were randomly assigned into the DIMS group or the control single-vision (SV) group. Refractive error and axial length measurements at baseline, three-, six-, nine-, and 12-month follow-up visits were monitored. The Quality of Life Impact of Refractive Correction (QIRC) questionnaire was used to evaluate the vision-related quality of life at baseline and at 12 months postintervention. Results: Of the initial cohort, a total of 151 children successfully completed the study (DIMS n = 72; SV n = 79). Baseline characteristics were similar between both groups. Average axial elongation and myopia progression after 1 year were 0.17 (95% CI 0.13-0.20) mm and -0.27 (95% CI -0.36 to -0.18) D in the DIMS group and 0.30 (95% CI 0.26-0.33) mm and -0.55 (95% CI -0.64 to -0.47) D in the SV group. The mean differences in axial elongation and myopia progression were 0.13 mm (95% CI 0.08-0.18 mm, p < 0.001) and -0.28 D (95% CI -0.41 to -0.15 D, p < 0.001) between the two groups. No significant difference in the QIRC score was found between the DIMS and SV groups (55.30 (95% CI 53.17-56.90) versus 54.20 (95% CI 51.99-56.41), p=0.854)). Conclusion: The use of DIMS lenses in children was found to slow down myopia progression compared to SV lenses, without negatively affecting their overall quality of life. Trial Registration: Clinical Trial Registry identifier: ChiCTR2000037443.

The aim of this study was to evaluate the efficacy of Orthokeratology (Ortho-K), defocus incorporated multiple segment (DIMS) lens, combined Ortho-K/atropine, and combined DIMS/atropine for myopia control in children. A retrospective study included 167 myopic children aged 6-14 years with a spherical equivalent refraction (SER) of -0.75 to -4.00 diopter treated with Ortho-K (OK, n = 41), combined Ortho-K/atropine (OKA, n = 43), DIMS (n = 41), or combined DIMS/atropine (DIMSA, n = 42). Axial length (AL) was measured at baseline and at 3, 6, 9 and 12 months. Axial elongation over time and between groups were analysed. After 12 months, the AL change was 0.20 ± 0.12 mm, 0.12 ± 0.14 mm, 0.22 ± 0.14 mm, and 0.15 ± 0.15 mm in the OK, OKA, DIMS, and DIMSA, respectively. There was no significant difference in AL change between OK and DIMS. OKA and DIMSA significantly slowed axial elongation compared to OK and DIMS monotherapy. After stratification by age, in the subgroup aged 6-10 years, there was significant difference in AL change between OKA and DIMS (p = 0.013), and no difference between other groups, while in the subgroup aged 10-14 years, the difference between OKA and DIMS became insignificant (p = 0.237), and the difference between OK and OKA, OK and DIMSA, DIMS and DIMSA became significant. Ortho-K and DIMS lenses show similar reductions in myopia progression among children with low initial myopia. Atropine can significantly improve the efficacy of myopia control of both Ortho-K and DIMS lenses, and this add-on effect is better in older children.

AimsTo report the 1-year results of the efficacy of a defocus distributed multipoint (DDM) lens in controlling myopia progression in a multicentre, randomised controlled trial.MethodsOverall, 168 children aged 6–13 years...

Purpose: to evaluate the effect of wearing glasses with Stellest® lenses on the spherical equivalent of refraction (SER) dynamics, the yearly progression gradient (YPG) and the axial length (AL) of the eye in children with progressive myopia 12, 18 and 24 months after the start of use. Material and methods. The main and the control groups of the study included children aged 8 to 13 years with low to moderate myopia at the beginning of observation. Stellest® glasses (the main group) were prescribed to 35 children with myopia 3.15 ± 0.19 D, while single vision (SV) glasses (the control group) were prescribed to 32 children with myopia 2.68 ± 0.18 D. The dynamics of the SER, YPG, and AL of the eye were assessed. Results. In the main (Stellest®) group, after 24 months of observation, SER increased by ave. 0.20 ± 0.06 D. YPG was shown to decrease in 93.5 % of cases by ave. 0.81 ± 0.05 D. The AL increased by an average of 0.15 ± 0.03 mm. In the control group, after 24 months of observation, the SER averaged 0.95 ± 0.08 D. YPG showed a decrease of ave. 0.38 ± 0.05 D in 61.1 % of cases. The AL of the eye increased by an average of 0.48 ± 0.04 mm. Conclusion. Stellest® glasses, if worn constantly, effectively slow myopia progression and axial elongation as compared with SV glasses. By the end of the follow-up period, in the Stelest® group, SER showed an increase by 79 % less than in the control group of SV glasses, and the AL showed increase in the length of the eye which was 69 % less than in the control group. Over the 24 months’ wearing of Stellest® glasses, YPG turned out to be 4.8 times lower than in the control group.

<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.