Randomized clinical trial of Diffusion Optics Technology spectacle lenses in a Chinese population (CATHAY): 12-month results

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.

To investigate the 1-year preventive efficacy of dual-surface aberration-increasing (DSAI) lenses on axial elongation and refractive change in non-myopic children. This was a 2-year randomized, controlled, prospective trial with a planned interim analysis at the 1-year follow-up to assess the preliminary efficacy and safety of DSAI lenses. One hundred children aged 6-12years with cycloplegic spherical equivalent refraction between-0.50 diopters (D) and + 2.00D, classified as non-myopic, were recruited. Participants were randomly assigned to wear either DSAI spectacle lenses or single-vision (SV) spectacle lenses in daily life. The primary outcomes were axial elongation and refractive change relative to baseline measurements, with axial elongation considered the main structural outcome in the results. Enrolment commenced in June 2023. One hundred participants were recruited, and 92 (DSAI group: n = 46, mean ± standard deviation age: 8.15 ± 1.49years; SV group: n = 46, 8.32 ± 1.62years) completed the 1-year follow-up. No intervention-related adverse events were observed during the study period. Participants in the DSAI group exhibited significantly less axial elongation (difference: 0.15mm; 95% confidence interval [CI]: 0.06 to 0.24mm; P = 0.002) and refractive change (difference:-0.26 D; 95% CI: -0.50 to-0.02 D; P = 0.032) than those in the SV group. Subgroup analysis showed that emmetropic children, older children (8.1-12.0years), and those wearing lenses for longer durations (≥ 11h/day) in the DSAI group had significantly less model-adjusted axial elongation than the corresponding SV subgroups (all P < 0.05). The 1-year interim results suggest that DSAI lenses help to slow axial elongation and refractive change in non-myopic children, with a relatively greater effect observed in emmetropic children, older children, and those who wore the lenses for longer durations. This trial is registered at Chinese Clinical Trial Registry with trial registration number: ChiCTR2300078464.

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.

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.

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.

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 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.

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.

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.

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.

AimsTo evaluate the myopia control efficacy of Diffusion Optics Technology (DOT) spectacle lenses in children over a 4-year treatment period.MethodsCYPRESS Part 1 (NCT03623074) was a 3-year multicentre, randomised, controlled, double-masked...

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.

BackgroundMyopia is increasing in prevalence and is currently recognized as a significant public health issue worldwide, particularly in China. Once myopia develops, appropriate clinical interventions need to be prescribed to slow its progression. Currently, several publications indicate that myopic defocus (MD) retards eye growth and myopia progression. However, no clinical trials have compared the outcomes of different MD spectacle lenses in the same observational group, especially in mainland China. The aim of the present study is to compare the myopia control efficiency of two different MD spectacle lenses: defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition lenses (PALs).MethodsThe trial is designed as a 3-year, prospective, randomized, multicenter clinical trial of schoolchildren treated with DIMS lenses and PALs. A total of 600 Chinese primary school children aged 6–12 years will be recruited, and each group is intended to include 300 subjects. The inclusion criteria are myopia between − 1.00 and − 5.00 diopters and astigmatism ≤ 1.50 diopters. The follow-up time points will be 1 month (m), 3 m, 6 m, 12 m, 18 m, 24 m, 30 m, and 36 m. The primary outcome will be determined by the difference between the two groups in cycloplegic spherical equivalent refraction between baseline and the last follow-up visit. The secondary outcome is the axial length, and the exploratory outcomes include ocular biometric measures, peripheral refraction, binocular vision, accommodation, compliance, and the results of questionnaires related to wearing experiences.DiscussionThe present study will be the first randomized controlled trial in myopic primary school children treated with DIMS lenses and PALs in China. The results will indicate whether and how much different MD mechanisms retard myopia progression and axial elongation. In addition, the comparison will provide information on the clinical efficacy and safety of DIMS lenses and PALs, including information related to wearing experiences and visual function.Trial registrationChinese Clinical Trial Registry (ChiCTR), ChiCTR1900025645. Registered on 3 September 2019. http://www.chictr.org.cn/showproj.aspx?proj=42927.

Effect of aspherical lens spectacles on axial length progression and refractive error in children with low to moderate myopia: a 24-month randomized controlled trial.

To determine whether photobiomodulation (PBM) therapy can retard ocular axial length (AL) in children with myopia. A randomized controlled clinical trial was conducted on two consecutive cohorts of 50 eligible children aged 8–12 years with ≤ − 0.75 Diopter (D) of spherical equivalent refraction (SER). Participants were randomly assigned to the intervention group (n = 25) and treated with PBM therapy or the control group (n = 25) and treated with single vision spectacles only. At the 12-month follow-up, the changes in AL and cycloplegic SER from baseline were both compared between the two groups. In addition, the subfoveal choroidal thickness (SFChT), anterior chamber depth (ACD), and central corneal refractive power (CCP) were analysed at the 3-, 6-, 9-, and 12-month follow-ups, respectively. Among the 50 children, 78% were included at the final follow-up, with a mean age of 9.7 ± 1.5 years and a mean SER of − 2.56 ± 1.70. The mean difference in AL growth between the two groups at 12 months was 0.50 mm (PBM vs. Control, − 0.02 mm ± 0.11 vs. 0.48 mm ± 0.16, P < 0.001), and the mean difference in cycloplegic SER at 12 months was + 1.25 D (PBM vs. Control, + 0.28 D ± 0.26 vs. − 0.97 D ± 0.25, P < 0.001). There were no significant differences in any of the other parameters (including SFChT, ACD, and CCP) between the two groups at any time point. PBM therapy is an effective intervention for slightly decreasing the AL to control myopia in children.Trial registration: Chinese Clinical Trial Registration Number: ChiCTR2100043619. Registered on 23/02/2021; prospectively registered. http://www.chictr.org.cn/showproj.aspx?proj=121302.