Defocus Incorporated Multiple Segments (DIMS) spectacle lenses in UK children: Outcomes from a 2‐year multi‐site interventional trial

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.

Clinical relevance Spectacle lenses with aspherical lenslets are effective in controlling axial elongation and slowing myopia progression in children with myopia, and its effectiveness may extend to children at risk of developing myopia. Background This study aims to examine the effectiveness of plano highly aspherical lenslets (HAL) spectacle lenses in slowing down axial elongation and spherical equivalent refraction (SER) progression among non-myopic children, using retrospective data records. Methods This retrospective study included data from medical records from an eye hospital network (Wellem Group) in Shanghai, China. Non-myopic children (non-cycloplegic SER between >-0.50 and ≤+0.75 D) aged 4–9 years, prescribed plano HAL lenses, were reviewed (N = 147). With available data prior to intervention, annualised changes in axial length and SER before and after wearing plano HAL lenses were computed. Effectiveness was evaluated with pre-treatment rates acting as controls, and differences in changes over time were calculated. Results A total of 105 non-myopic children were prescribed plano HAL lenses and had both pre-treatment and post-treatment visits (≥6 months). The mean ±SD age, SER, and axial length was 6.8 ± 1.3 years, 0.22 ± 0.29 D, and 23.1 ± 0.7 mm, respectively. The mean ±SE axial length and SER pre-treatment change was +0.44 ± 0.01 mm/year and −0.28 ± 0.03 D/year, respectively. After treatment, the mean axial length and SER change were +0.13 ± 0.01 mm/year and +0.14 ± 0.03 D/year, respectively. The mean difference in axial length and SER change over time was significantly different at −0.31 ± 0.02 mm/year and 0.42 ± 0.06 D/year, respectively (both p < 0.001). Lens wearing time was significantly associated with difference in axial length change over time (R2 = 0.19, p < 0.001). Conclusion Plano HAL lenses are effective in slowing axial elongation and SER progression among non-myopic children aged 4–9 years, which can potentially help in delaying myopia onset.

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.

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.

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.

PurposeTo evaluate the efficacy and safety of the new defocus spectacle lens in preventing myopia progression compared with the conventional single-vision spectacle lens (SVL).DesignA randomized, open-label, controlled clinical trial.SubjectsChildren aged 6 to 14 years with a cycloplegic spherical equivalent refraction (SER) of –1.00 to –3.50 diopters (D) in both eyes were enrolled.MethodsEligible participants were randomly assigned in a 1:1 ratio to receive either the novel defocus spectacle lens (MYOGEN) or the SVL. Data from the right eyes at the 12-month follow-up were used for the current analysis.Main Outcome MeasuresThe primary outcome was the 1-year change in SER from baseline to 12 months. Secondary outcomes included changes in axial length (AL), choroidal thickness, subjective visual quality scores, and daily spectacle wear time. Axial length was designated as the main secondary outcome due to its close relationship with myopia progression.ResultsA total of 85 patients were assigned to the MYOGEN group and 89 to the SVL group, with mean (standard deviation) ages of 10.44 (0.92) years and 10.61 (0.73) years, respectively. After 1 year, myopia progression and axial elongation were all significantly less in the MYOGEN group than in the SVL group (SER change: –0.80 ± 0.44 D and –1.06 ± 0.51 D, respectively; AL change: 0.25 ± 0.15 mm and 0.37 ± 0.18 mm, respectively; all P < 0.001). Among patients with good compliance (≥8 hours/day and ≥5 days/week), the treatment effect was even more pronounced for SER (adjusted difference: 0.40 D [95% confidence interval [CI], 0.25 to 0.56]) and AL (adjusted difference: –0.15 mm [95% CI, –0.21 to –0.10]). No significant between-group differences were observed in compliance with spectacle wear and subjective visual quality.ConclusionsCompared with the SVL, MYOGEN was shown to reduce myopia progression and axial elongation over the 1-year follow-up period.Financial Disclosure(s)Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Background/aimsThe global increase in childhood myopia underscores the need for effective control strategies. This study compares the effectiveness of Defocus Incorporated Multiple Segments (DIMS) spectacle lenses versus 0.01% atropine eye drops in slowing myopia progression in European children. This report summarises 1-year outcomes from an ongoing 2-year clinical trial.MethodsA total of 110 Polish children aged 6–16 years, without significant ocular pathology, were randomly assigned to two groups. Group A received single-vision spectacles plus nightly 0.01% atropine drops; group B received DIMS spectacle lenses plus nightly placebo drops. Primary outcomes were changes in cycloplegic spherical equivalent refraction (SER) and axial length, measured every 6 months.ResultsAfter 12 months, mean axial elongation was 0.19±0.03 mm in group A and 0.11±0.02 mm in group B. Among 6–11-year olds, group A showed greater elongation (0.30±0.05 mm) than group B (0.15±0.02 mm). For 12–16-year olds, axial elongation was 0.10±0.02 mm in group A and 0.07±0.02 mm in group B. Mean SER progression was 0.37±0.06 D in group A and 0.23±0.05 D in group B. In the younger group (6–11 years), SER progression was higher in group A (0.60±0.1 D) than group B (0.25±0.05 D). Among older children (12–16 years), SER changes were similar between groups (0.19±0.05 D vs 0.21±0.08 D).ConclusionDIMS spectacle lenses demonstrated superior efficacy to the 0.01% atropine in controlling myopia progression in this cohort, particularly among children aged 6–11 years. These findings support DIMS lenses as an effective intervention for myopia control in Caucasian populations.

This study compared the 12-month real-world effectiveness of defocus incorporated multiple segments (DIMS) spectacle lenses, Myopi-X progressive addition lenses, and single-vision (SV) lenses in slowing myopia progression in children. This retrospective observational study included 385 eyes using one of the three spectacle types. Baseline age, spherical equivalent refraction (SER), and axial length (AL) were recorded. Twelve-month changes in SER and AL were analyzed using the Kruskal-Wallis test with Bonferroni-adjusted pairwise comparisons. Generalized estimating equations (GEE) were used to assess the effects of treatment group, age group, sex, and baseline AL group on SER and AL changes. The study population consisted of 118 Myopi-X eyes (32.4%), 107 SV eyes (29.4%), and 139 DIMS eyes (38.2%). Baseline demographic and ocular characteristics (including age, sex, SER, AL, age group, and baseline AL group) were comparable among the groups (all p>0.05). After 12 months, mean SER progression was -0.35±0.34 diopters (D) in the Myopi-X group, -0.46±0.37 D in the SV group, and -0.24±0.33 D in the DIMS group (p<0.001). Mean AL elongation was 0.21±0.12 mm, 0.24±0.17 mm, and 0.17±0.16 mm, respectively (p=0.004). GEE analyses demonstrated a significant treatment effect for both SER and AL change (p<0.001 for both). The least progression occurred in the DIMS group, followed by Myopi-X, while the SV group showed the highest progression. Baseline AL group was the only significant predictor of AL elongation (β=0.210, 95% confidence interval: 0.189-0.231, p<0.001), with greater elongation in eyes with high baseline AL. Age group and sex did not significantly influence SER or AL outcomes. DIMS spectacle lenses were more effective than Myopi-X and SV lenses in reducing both refractive progression and axial elongation over 12 months. Baseline AL was a key determinant of axial growth, supporting the use of individualized risk assessment in pediatric myopia management.

Real-world outcomes on myopia management efficacy of diverse segmented defocus optics (DSDO) and defocus incorporated multiple segments (DIMS) spectacle lenses in Chinese children: An initial 12-month prospective clinical study.

To evaluate the 12-month myopia control efficacy of an asymmetric multipoint defocus technique (AMDT) spectacle lens. Double-masked randomized controlled trial. One hundred forty participants completed all visits (mean age, 10.6 ± 1.5 years; 50% female), with spherical equivalent refraction (SER) between -5.00 and -0.75 diopters (D), astigmatism of 1.50 D or less, and anisometropia of 1.50 D or less. One hundred forty-four children 8 to 13 years of age with myopia of -0.75 D to -5.00 D recruited from 2 ophthalmic centers were randomized (1:1) to wear AMDT spectacle lenses or single-vision lenses (SVLs). Cycloplegic SER and axial length (AL) were measured at the baseline, 6-month, and 12-month visits. Adaptation and visual performance questionnaires were administered during the intervention. The SER change after 1 year was the primary outcome, and the changes in AL, visual performance, and ocular parameters after 1 year were defined as secondary outcomes. After 12 months, the SVL group (n = 69) exhibited mean changes in SER and AL of -0.50 ± 0.06 D and 0.32 ± 0.02 mm, respectively, compared with -0.16 ± 0.06 D and 0.17 ± 0.02 mm (both P < 0.001) in the AMDT group (n = 71). Compared with the SVL group, participants in the AMDT group showed significantly less myopia progression by 0.39 D in SER (74%) and 0.17 mm in AL (51%) after adjustment for baseline age, baseline SER and AL, and ophthalmic center. The correlation between younger age and more rapid AL elongation was more pronounced in the SVL group (r = -0.68; P < 0.001) compared with the AMDT group (r = -0.37; P = 0.002). Thirty participants (42%) in the AMDT group displayed no SER progression after 1 year. No serious adverse events or persistent visual discomfort were observed. Compared with SVLs, AMDT spectacle lenses significantly reduced SER and AL progression over 1 year, with a favorable safety profile and visual performance. The correlation between age and myopia progression was diminished after AMDT participants intervention, but not for SVLs. The author(s) have no proprietary or commercial interest in any materials discussed in this article.

To investigate myopia control efficacy in children who continued wearing spectacle lenses with highly aspherical lenslets (HAL) or switched from spectacle lenses with slightly aspherical lenslets (SAL) and single-vision spectacle lenses (SVL) to HAL for 1 year after a 2-year myopia control trial. This was a 1-year extension of a randomized clinical trial. Of 54 children who had worn HAL for 2 years, 52 continued wearing HAL (HAL1 group), and of the 53 and 51 children who had originally worn SAL or SVL, 51 and 48 switched to wearing HAL (HAL2 and HAL3 groups) in year 3, respectively. A new SVL (nSVL) group of 56 children was recruited, matched for age, sex, cycloplegic spherical equivalent refraction (SER), and axial length (AL) of the HAL3 group at extension baseline, and used for a comparison of third-year changes. SER and AL were measured every 6 months in year 3. During year 3, the mean (SE) myopia progression in the nSVL group was -0.56 (0.05) diopters (D). Compared with nSVL, the changes in SER were less in HAL1 (-0.38 [0.05] D, P=.02), HAL2 (-0.36 [0.06] D, P=.01), and HAL3 (-0.33 [0.06] D, P=.005). The mean (SE) AL elongation in the nSVL group was 0.28 (0.02) mm. Compared with nSVL, the elongation in AL was less in the HAL1 (0.17 [0.02] mm, P < .001), HAL2 (0.18 [0.02] mm, P < .001), and HAL3 (0.14 [0.02] mm, P < .001) groups. Myopia progression and axial elongation were comparable in all 3 HAL groups (all P > .05) in year 3. Myopia control efficacy has remained in children who wore HAL in the previous 2 years. Children who switched from SAL or SVL to HAL in year 3 had slower myopia progression and axial elongation than that in the control group.

This study aimed to evaluate the efficacy of 18-month 0.01% atropine in 61 myopic children (aged 7–10) and the relationship with central retinal response (by multifocal electroretinogram [mfERG]) in a double-masked randomized placebo-controlled clinical trial. Global-flash mfERG was measured at baseline, while cycloplegic spherical equivalent refraction (SER) and axial length (AL) were measured at baseline and at 6-month intervals. Annualized change in SER and AL were compared between atropine and control groups, and the relationships with baseline mfERG were evaluated. Changes in SER (−0.70 ± 0.39D vs. −0.66 ± 0.41D, p = 0.63) and AL (0.32 ± 0.16 mm vs. 0.30 ± 0.22 mm, p = 0.52) were similar in atropine and control groups. Interestingly, in the placebo group, mfERG amplitude was negatively correlated with axial elongation (Rp = −0.44, p = 0.03) as in our previous study. However, in the atropine group, an opposite trend was observed that axial elongation was positively correlated with mfERG amplitude (Ra = 0.37, p = 0.04). Annualized myopia progression demonstrated similar opposite effect between atropine and placebo groups but did not reach statistical significance. An ERG screening protocol may be warranted to identify suitable candidates to reduce the likelihood of an unfavorable treatment response by 0.01% atropine.

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

Childhood myopia progression remains a major global public health concern, and spectacle lenses designed to induce peripheral myopic defocus have emerged as a non-pharmacological strategy for myopia control; however, real-world evidence from European populations remains limited. This retrospective observational study evaluated the 12-month real-world effectiveness of cylindrical annular refractive element spectacle lenses in a Turkish pediatric cohort. Children aged 5-15 years who wore myopia-control spectacle lenses from the CARE platform or single-vision lenses were included. Cycloplegic spherical equivalent refraction (SER) and axial length (AL) were measured at baseline and at 12 months. The primary outcomes were 12-month changes in SER and AL. Multivariable generalized estimation equations were applied to account for inter-eye correlation and to adjust for age and gender. A total of 168 eyes were analyzed (85 with single-vision lenses; 83 with myopia-control lenses). After 12 months, the myopia-control group demonstrated significantly slower progression than the single-vision group, with mean SER changes of -0.40 ± 0.92 D versus -0.77 ± 0.74 D and axial elongation of 0.17 ± 0.25 mm versus 0.31 ± 0.30 mm, respectively. Treatment group remained a significant predictor of both refractive progression (p = 0.008) and axial elongation (p = 0.003). Age was independently associated with axial length change (p < 0.001), whereas gender was not. These findings provide real-world European evidence supporting the role of defocus-modulating spectacle lenses in pediatric myopia management.

PurposeTo evaluate myopia control efficacy in myopic children wearing spectacle lenses with highly aspherical lenslets (HAL) for 5 years.MethodsThis is a randomized, double-masked extended trial. Myopic children aged 8 to 13 years who were originally allocated to the HAL group in the 2-year clinical trial. The HAL group underwent a 5-year assessment for myopia progression using cycloplegic spherical equivalent refraction (SER) and axial length (AL). An extrapolated single-vision spectacle lenses (ESVL) group was used as a control group. The 5-year myopia progression and axial elongation of the ESVL group was calculated based on the 2-year data from the single-vision spectacle lenses group in the same clinical trial, and the data for the following 3 years was estimated by assuming an annual reduction in SER by 9.7% and in AL by 15%. A generalized linear model approach was used to evaluate the treatment efficacy. The validity of the ESVL group was evaluated by comparing myopia progression in the first year of the 3-year estimates with a single-vision spectacle lenses (SVL2) group from a 1-year extended study of the same clinical trial.ResultsForty-three participants from the original HAL group completed the 5-year visit (74%). Five-year myopia progression [mean ± standard error (SE)] in the HAL group was − 1.27 ± 0.14 D. Compared with the ESVL (− 3.03 ± 0.18 D), myopia progression was − 1.75 ± 0.24 D less for the HAL group (P < 0.001). The mean AL elongation over 5 years was 0.67 ± 0.06 mm for the HAL group compared with 1.40 mm in the ESVL group (P < 0.001), AL elongation was slower by 0.72 ± 0.10 mm for the HAL group (P < 0.001). No significant differences were found for myopia (− 0.58 ± 0.04 D vs. − 0.56 ± 0.05 D) or AL elongation (0.28 ± 0.02 mm vs. 0.28 ± 0.02 mm) between the ESVL group and SVL2 group (PSER = 0.83; PAL = 0.93) in year 3.ConclusionsIn this 5-year study, HAL spectacles reduced the rate of myopia progression and axial elongation, preventing the equivalent of 3 years of myopia progression and axial elongation. Long-term use of HAL spectacles also decreased the incidence of high myopia. Extrapolated control groups are valid for evaluating myopia progression in long-term studies.Trial registration The study was registered at the Chinese Clinical Trial Registry (ChiCTR2100047262), https://www.chictr.org.cn/showproj.html?proj=127182.