Control of myopia using diffusion optics spectacle lenses: 4-year results of a multicentre randomised controlled, efficacy and safety study (CYPRESS)

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.

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.

Purpose. The prevalence of myopia is increasing worldwide and its long-term effects can have major impacts on eye health. Paediatric onset of myopia leads to a higher risk for developing high levels of myopia in adulthood. Slowing down or stopping myopia progression is an important task for the future. Material and Methods. Based on a literature review, the latest developments in the field of myopia control for children were summarized. The current study situation for orthokeratology, soft contact lenses, atropine therapy and spectacle lenses for the management of myopia is discussed in detail. Results. Results on the safety and effectiveness of orthokeratology and modified soft contact lenses are exceedingly consistent. Soft multifocal contact lenses, as well as newer spectacle lenses, recently received regulatory approval for myopia control. Studies on the administration of atropine recommend a dosage of 0.01 - 0.05 %. All methods slow down myopia progression and decrease axial length growth of the eye. Side effects, adverse events or discontinuation of treatment only occur in the rarest of cases. Orthokeratology and atropine continue to deliver the best results. Conclusion. From today’s perspective, carrying out myopia control can be recommended with great certainty. The choice of method depends on the individual requirements of each patient, with all methods offering success in reducing myopia progression. In the future, even more advanced contact lens geometries, more precise atropine dosages or improved optics of spectacle lenses will further increase the success of the treatment. Keywords. Progressive myopia, myopia control, children, contact lenses, atropine, spectacle lenses

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.

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.

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.

To explore the difference in myopia control efficacy between spectacle lenses with highly aspherical lenslets (HAL) combined with 0.01% atropine eye drops and spectacle lenses with HAL alone or single vision spectacle lenses (SVL) in children and adolescents. A retrospective cohort study was conducted with a total of 105 myopic children aged 6-15 years. According to the specific myopia correction and control methods of each subject, they were evenly divided into the HAL+0.01% atropine (HAL+AT) group, the HAL group, and the SVL group, with 35 subjects in each group. Relevant data, such as cycloplegic refraction and axial length (AL) at baseline and 12 months after wearing spectacles, were retrieved. One-way analysis of variance, or the Kruskal-Wallis test, was used to analyze the changes in AL and spherical equivalent refraction (SER) after wearing spectacles for 12 months in comparison to those at baseline in the three groups. There was no statistically significant difference in the baseline parameters and duration of wearing spectacles among the three groups (P>0.05). After wearing spectacles for 12 months, the changes in SER were －0.13 (－0.25, 0.00) D, －0.25 (－0.63, －0.25) D, and －0.63 (－1.00, －0.25) D in the HAL+AT group, HAL group, and SVL group, respectively; AL elongation in the three groups was (0.09±0.11) mm, (0.19±0.16) mm, and (0.34±0.16) mm, respectively. The HAL+AT group exhibited slower SER changes (P HAL+AT vs. HAL=0.001, P HAL+AT vs. SVL=0.002) and AL elongation (P HAL+AT vs. HAL=0.009, P HAL+AT vs. SVL=0.001) than those of the HAL and the SVL groups. Compared with those of the SVL group, myopia progression was reduced by 79.4% and AL elongation was slowed down by 73.5% in the HAL+AT group, while in the HAL group, myopia progression and AL elongation were reduced by 60.3% and 44.1%, respectively. According to stratified analysis based on age and myopia progression rate, among younger children aged 6 to 8 years and older children aged 9 to 15 years, the HAL+AT group had a significantly lower proportion of subjects experiencing fast AL elongation (AL>0.36 mm/year) and a significantly higher proportion of subjects experiencing slow AL elongation (AL≤0.18 mm/year) compared to the SVL group (P<0.017). The combination intervention of spectacle lenses with HAL and 0.01% atropine eye drops is effective in controlling myopia progression in children and adolescents, with better myopia control effect achieved using this combination intervention in myopic children of all ages.

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.

Purpose. To study the efficacy of spectacle lenses with highly aspherical lenslets (Stellest™) on refraction, axial length (AL) and accommodation in children with progressive myopia. Methods. The study included 259 children (518 eyes) aged 7 to 16 years (10.0±1.7 years) with progressive myopia from –0.5 D to –7.0 D (mean cycloplegic spherical equivalent refraction –2.6±1.6 D), astigmatism was present in 31 % of cases. Spectacles with Stellest™ lenses were always prescribed for continuous wear (at least 12 hours per day). Follow-up period was 6 months in 129 children (258 eyes), 12 months in 110 children (220 eyes) and 24 months in 47 children (94 eyes) from the beginning of Stellest™ wearing. Results In the first 6 months, stabilization of refraction was achieved in 82 % of patients (212 eyes), and in 14 % of patients (36 eyes) a hyperopic shift of refraction within +0.5 D was revealed. During 12 months of follow-up, stable cycloplegic refraction was detected in 80 % of cases (178 eyes). A hyperopic shift of refraction within +0.5 D and myopia progression up to –0.75 D were equally common: in 10 % of patients (21 eye in each group). During 2 years of follow-up, stable cycloplegic refraction was detected in 53 % of cases (50 eyes). A hyperopic shift of refraction within +0.5–0,75 D was noted in 17 % of patients. In some children myopia progressed, but the rate of progression decreased by 2 times or more. Thus, myopia progression by 0.25 D over 2 years of follow-up was detected in 14 % of patients (14 eyes), by 0.5 D – in 6 % (6 eyes) and by 1.25–1.5 D – in 10 % of patients (10 eyes). Mean initial axial length (AL) of the eyes was 24.5±0.1 mm. For the first 6 months, AL increase did not exceed 0.02±0.01 mm, for 12 and 24 months – 0.1±0.02 mm. Conclusions. Spectacle lenses with highly aspherical lenslets (HAL) effectively slow down myopia progression and axial elongation of the eyeball. Stabilization of refraction within 24 months was achieved in 70 % of patients. Accommodation has improved in all patients. Key words: myopia progression in children; peripheral myopic defocus; lenses with highly aspherical lenslets; Stellest™.

This study evaluated the effectiveness of defocus incorporated multiple segments (DIMS) spectacle lenses in controlling myopia progression and axial elongation in a Turkish paediatric population over a 12-month period. This retrospective observational study included 97 children (194 eyes), aged 6-16 years, who were prescribed either DIMS lenses (n = 54) or single vision spectacle lenses (SVSLs, n = 43). Cycloplegic spherical equivalent refraction (SER) and axial length (AL) were measured at baseline and after 12 months. Treatment effectiveness was assessed using generalised estimating equations (GEE) and subgroup analyses were conducted based on age group, gender and baseline AL. After 12 months, the DIMS group exhibited significantly less myopia progression (-0.28 D [0.42]) compared with the SVSL group (-0.74 D [0.75]), indicating a 62% reduction in SER progression (p < 0.001). Axial elongation was also significantly lower in the DIMS group (0.14 mm [0.31]) than in the SVSL group (0.29 mm [0.31]), corresponding to a 52% reduction (p < 0.001). Subgroup analyses revealed that younger age and high baseline AL were consistently associated with greater SER progression and AL elongation across both groups. In the DIMS group, high baseline AL predicted poorer outcomes, but age and gender were not significant predictors. DIMS spectacle lenses effectively reduced myopia progression and axial elongation in children compared with SVSLs. These lenses offer a safe and non-invasive method for myopia control, being especially beneficial for younger patients or those with higher baseline axial length.

Longitudinal Changes and Predictive Value of Choroidal Thickness for Myopia Control after Repeated Low-Level Red-Light Therapy

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.

To evaluate the efficacy of myopia control by spectacle lenses in a real-world study. This is a longitudinal, retrospective, comparative, observational, real-world study of the French Myopia Cohort. Records of prescriptions for optical correction, gender and age were collected from 1500 opticians between 2020 and 2023. The study cohort consisted of myopic children aged 4 to 15 years who were assigned to three groups: two control groups wearing single vision lenses (SVL) and one intervention group wearing myopia control spectacles (MCS); either defocus incorporated multiple segments (DIMS, n=1786) or highly aspheric lenses (HAL, n=585). The first SVL group was matched to the MCS group for age, sex and initial refractive error (first matching), and the second SVL group was matched for the same criteria and myopia progression during the first 6 months of follow-up (second matching).The difference in myopia progression was calculated between SVL groups and the MCS group. DIMS and HAL were also compared for myopia progression. A total of 2542 children (mean age of 9.5 years and mean spherical equivalent of -2.3 D at baseline) were included in each of the three groups. The mean progression rates for MCS were by +0.59 D (95% CI +0.57 to +0.62D; p<0.001) after the first matching and by +0.30 D (95% CI +0.28 to +0.32D; p<0.001) after the second matching, in comparison to the SVL groups. Children wearing HAL spectacles showed slightly less myopia progression (difference in progression = +0.14 D, 95% CI = +0.10 to +0.18, p<0.001) compared with the DIMS group. Although there are some limitations, including its retrospective design, the lack of lifestyle and environmental data and the use of SE rather than axial length, this study showed that in a real-world setting, both DIMS and HAL spectacles demonstrated efficacy in reducing myopia progression. While a statistically significant lower myopia progression rate was observed in the HAL group, this difference was not clinically meaningful. This study also showed that DIMS and HAL reduce myopia progression among younger children aged 4 to 6 years.

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.

IntroductionMyopia is a growing public health concern with long‐term risks for visual impairment. While Defocus Incorporated Multiple Segments (DIMS) spectacle lenses have proven efficacy in Chinese children, evidence from Western populations remains limited. This multi‐site interventional study evaluates the effectiveness of DIMS lenses in slowing myopia progression and their visual acceptability and tolerability among UK children.MethodsChildren aged 5–15 years with cycloplegic spherical equivalent refraction (SER) of −0.50 to −8.50 D, anisometropia ≤1.50 D and astigmatism ≤2.50 D were recruited. All participants were prescribed DIMS spectacle lenses. SER (cycloplegic autorefraction) and axial length (AL, IOLMaster) were measured at baseline and at 6‐monthly intervals for 24 months. Measured axial elongation was compared to expected eye growth in age‐ and ethnicity‐matched untreated myopes from published meta‐analyses. Visual function (distance/near visual acuity, stereoacuity, accommodative lag and ocular posture) and visual symptoms (participant questionnaire) were also assessed.ResultsA total of 108 participants completed the study to 2 years (baseline age 10.2 ± 2.2 years). Model‐adjusted mean (SE) changes in SER and AL change were −0.35 ± 0.04 D and 0.17 ± 0.01 mm at 12 months and −0.57 ± 0.05 D and 0.30 ± 0.03 mm at 24 months. Compared to expected untreated myopic progression, children wearing DIMS spectacle lenses showed 0.27 ± 0.20 mm (mean ± SD) less axial elongation over 24 months, with 91% exhibiting slower than average untreated myopic eye growth. Measures of visual function were comparable through DIMS and single‐vision spectacle lenses. Fifty‐seven percent of participants reported no visual symptoms within the first week, and on average, visual symptoms were ‘never’ or ‘seldom’ experienced by participants after 12 and 24 months of DIMS wear.ConclusionsThis study provides robust and novel evidence demonstrating that DIMS spectacle lenses provide meaningful slowing of axial elongation among UK children. Minimal visual symptoms and preserved visual function throughout lens wear support their clinical viability and real‐world applicability for myopia management in diverse populations.