The rising global prevalence of both myopia and high myopia (myopia > −6.00 D) have caused both conditions to become major public health concerns.1 It is predicted that high myopia will affect nearly 10 % of the global population by 2050 if the phenomenon of myopic progression is left unaddressed.2 This is of most concern in East and Southeast Asia, where the reported prevalences of high myopia range from 10–20 %.3 High myopia is an irreversible eye disease often accompanied by complications such as retinal detachment, macular degeneration, posterior staphyloma, choroidal neovascularization, and glaucoma.4,5 The risk of myopia-related complications increases with each diopter of myopia;6 thus, slowing or halting myopia progression, even in high myopes, is crucial. Therefore, developing interventions to slow the progression of myopia and reduce the incidence of high myopia has become an urgent problem to be solved.

Optical devices provide a safe and convenient method for myopia correction. Many myopia control strategies are based on the peripheral defocus theory, which has led to the development of specially spectacle lenses and multifocal contact lenses. Currently, novel spectacle lenses incorporating peripheral myopic defocus have demonstrated efficacy in slowing myopia progression. Defocus Incorporated Multiple Segments Lenses (DIMS) lenses have shown promising results in achieving effective myopia control in one year or long-term visit.7–9 Lam et al. reported significantly shower myopia progression with DIMS lenses compared to single-vision spectacles, with mean annual changes of −0.17±0.05 D versus −0.55±0.04 D (1-year data) and −0.41±0.06 D versus −0.85±0.08 D (2-year follow-up).7 The 3-year follow-up demonstrated sustained efficacy, with SE and AL changes of −0.52±0.69 D and 0.31±0.26 mm, respectively.8 The 6-year cohort maintained consistent control, showing comparable progression rates between initial and later periods (SE: −0.52±0.66 vs −0.40±0.72 D; AL: 0.32±0.26 vs 0.28±0.28 mm; both p > 0.05).9 In clinical practice, efforts have been made to expand the scope of DIMS applications. Domsa P et al. study10 assessed the effectiveness of DIMS lenses in managing myopia up to −8.25 D and astigmatism up to −3.25 D, reporting a one-year spherical equivalent (SE) change of −0.40 ± 0.05 D (n = 62) and an axial length (AL) change of 0.16 ± 0.03 mm (n = 33). However, the study did not exclusively assess the efficacy of DIMS lenses in controlling high myopia. Previous studies reported decreasing efficacy of DIMS lenses with increasing spherical equivalent (SE) among children,11 or no significant difference compared to the SVLs,12 suggesting that there was limited effect of DIMS for children with high myopia. Thus, developing more effective interventions for managing high myopia is essential.

Recently, multifocal soft contact lenses (MFSCLs), known for their acceptability, comfort, and greater efficacy, have been well-received by children. Previous studies have reported that the effectiveness of MFSCLs in reducing myopic progression over one year ranges from 38 % to 74 %13–16 in low to moderate myopia. The amount of myopic progression, determined by computing annual shifts in SE, ranges from 0.22 to 0.81 D in those wearing multifocal soft contact lenses and from 0.50 to 1.45 D in control groups who wore single-vision spectacles or single-vision contact lenses over at least 1 year.17 A similar soft multifocal design, daily disposable defocus incorporated soft contact lenses (DISC), feature a concentric ring design with a central corrective zone and alternating defocus zones (+2.50 D add), was also effective in reducing axial length elongation (52.3 %) compared to single vision contact lenses over a 2-year follow-up period in Hong Kong schoolchildren.13 Although multifocal soft contact lenses can correct myopia up to −20.00 D,18–20,22 their efficacy as an intervention in children with high myopia remains underexplored. To date, some studies19,20 have evaluated this, involving 96 Caucasian children with myopia ranging from −0.75 D to −10.00 D who were fitted with Extended Depth of Focus (EDOF) soft contact lenses. A 2-year follow-up showed a myopia control effect of −0.62 ± 0.30 D with MYLO lenses, compared to −1.13 ± 0.20 D with SVLs.19 At 3 years, the corresponding values were −0.90 ± 0.36 D (MYLO) and −1.64 ± 0.26 D (SVLs).20 However, it should be noted that high myopia cases represented <5 % of the study population. Moreover, races variations in treatment response to multifocal soft contact lenses may exist among myopia children.

Therefore, we aimed to preliminarily evaluate the efficacy of MFSCLs and DIMS lenses in Chinese children with high myopia by retrospective study and to identify potential factors influencing their effectiveness.

The baseline characteristics of the study subjects are shown in Table 1. The subjects’ age ranged from 8 to 16 years (12.1 ± 2.0 years). Age distribution was as follows: 8 years (n = 9), 9 years (n = 21), 10 years (n = 25), 11 years (n = 47), 12 years (n = 39), 13 years (n = 37), 14 years (n = 46), 15 years (n = 18), and 16 years (n = 7). The baseline SE ranged from −6.00 to −10.00 D (−7.15 ± 0.88 D). There were no significant differences in age, sex, and SE between each group at baseline (all P > 0.05). No adverse events (e.g., corneal infection) occurred during follow-up.

Table 2 shows the changes in SE in each group. Myopic progression tended to occur in each group: the mean change in spherical equivalent (∆SE) was −0.71±0.54D (SVLs), −0.47±0.39D (DMIS) and −0.39±0.47D (MFSCLs). The between-group difference was statistically significant (Z = 9.664, P < 0.001). The efficacy of myopia control, defined as the difference between the change in SE in single-vision spectacle vs. myopia intervention, was 0.23 D for DIMS and 0.32 D for MFSCLs. Table Appendix 1 presents the one-year SE changes stratified by age group for all three treatment modalities (SVLs, DIMS, and MFSCLs).

To further compare myopic progression between each group, we examined the proportion of slow, moderate, and fast progressors in each lens modality group and found significant differences (χ2=13.221, P = 0.010). The Fig. 1 demonstrated that while the SVLs group showed nearly equal distribution across fast (▵SE≤−0.75D/year), moderate (▵SE −0.25D to −0.75D/year), and slow (▵SE≥−0.25D/year) progression categories (each ∼33 %), the DIMS group exhibited a significant shift toward slower progression (slow: 39.81 %, moderate: 40.74 %, fast: 19.44 %; P = 0.035), with an even more pronounced slow-progression shift observed in the MFSCLs group (slow: 51.67 %, moderate: 33.33 %, fast: 15.00 %; P < 0.001).

Fig. 1.

Percentage of subjects with different myopic progression (slow, moderate, fast) in SVLs, DIMS, and MFSCLs groups.

Multiple linear regression analyses indicated baseline age, but not sex and SE, was the covariate most associated with 1-year myopia progression in both SVLs and DIMS groups (Table 3, β=0.120, β=0.108, all P < 0.001). The older subjects showed slower myopia progression in those groups. In contrast, for the MFSCLs group, baseline age did not appear to be associated with myopia progression in children with high myopia.

We analyzed age-related myopia progression in high myopia children. Fig. 2 compares progression rates across groups at a fixed age. The slopes of those two groups appeared the same, indicating that the DIMS group achieved a similar advantage over the SVLs group at all ages. However, the flat regression line of the MFSCLs group suggests that the ▵SE varied little across different ages. The confidence intervals for the DIMS and MFSCL groups began to overlap around age 12, with the predicted regression lines for the two groups intersecting at approximately age 13. In children younger than 12, the MFSCLs group achieved better myopia control than DIMS and SVLs. After 12 years of age, MFSCLs advantage gradually disappeared.

Fig. 2.

Age-dependent effects on myopia progression across different intervention groups. Blue: SVLs group, red: DIMS group, green: MFSCLs group. The shaded area represents the 95 % confidence interval.

To the best of our knowledge, this is the first study to analyses and compare the efficacy of MFSCLs and DIMS in slowing myopia progression in children with high myopia. Previous studies conventionally focused on low-to-moderate myopia wearing bifocal or multifocal contact lenses, effective between 37 % and 74 %.6,13–16 This study found numerically similar efficacies for either MFSCLs (45.1 %) towards the retardation of myopia progression in children with high myopia. The 1-year myopia progression was −0.39 ± 0.47 D in the MFSCLs group compared to −0.71 ± 0.54 D in the SVLs group. Additionally, MFSCLs have shown greater efficacy in slowing myopic progression, with half of the subjects with an annual refractive change of <0.25 D. We hypothesize that MFSCLs, compared to spectacle lenses, reduce the vertex distance, allowing the multifocal imaging to align more accurately on the retina. However, the distribution and effect of defocus signals on the retina require further investigation. There is limited to no evidence regarding the efficacy of either multifocal soft contact lenses in controlling high myopic progression.19,20 The study by Diaz-Gomez et al. reported that after 2 years treatment, the EDOF soft contact lens group showed significantly less myopia progression than single-vision spectacles in children aged 6–13 years with myopia ranging from −0.75 to −10.00D Mean changes were −0.62±0.30D SE and 0.37±0.04 mm AL for EDOF lenses versus −1.13±0.20D SE and 0.66±0.03 mm AL for spectacles (p < 0.001).19 After three years of treatment, the mean changes in SE and AL were −0.90 ± 0.36 D and 0.55 ± 0.04 mm in the EDOF group, compared to −1.64 ± 0.26 D and 0.97 ± 0.03 mm in the spectacle group, respectively (all p < 0.001).20 The study did not perform subgroup analyses based on baseline refractive error, particularly for high myopia cases (≤−6.00D), which precludes definitive conclusions about treatment efficacy in this specific population. Our study aimed to provide theoretical support for MFSCLs as a potential intervention for high myopia.

Some studies have shown that myopia continues to progress in children with high myopia.24 In Xu's study,25 children with a mean age of 12.54 ± 2.53 years exhibited an annual myopia progression of −0.76 ± 0.46 D and an axial length growth (ALG) of 0.23 ± 0.14 mm. High myopia progression remains a concern, and interventions such as DIMS spectacle lenses have been introduced to address this issue. Liu et al.11 reported a one-year follow-up in highly myopic individuals, showing a change in SE of −0.50 ± 0.41 D in the DIMS group compared to −0.46 ± 0.76 D in the SVL group, with no significant difference between the two groups. The absolute SE change observed with DIMS in their study is similar to our research findings. In clinical practice, some researchers have combined DIMS lenses with low-concentration atropine to enhance their myopia control efficacy. Among children aged 6–14 years with myopia less than −4.00 D, the combination of DIMS lenses and low-concentration atropine achieved better axial length control (0.15 ± 0.15 mm) compared to the DIMS-only group (0.22 ± 0.14 mm).26 In clinical practice, for DIMS lens wearers, regular axial length monitoring is essential. Combination therapy should be considered if progression remains significant despite treatment.27

Previous studies have demonstrated an association between age and myopia progression,11,28 a phenomenon observed in the DIMS and SVL groups. The age-dependent efficacy of MFSCLs suggests that in children younger than 12 years, the MFSCL group exhibited superior myopia control compared to the DIMS and SVLs groups. However, this advantage progressively declined after the age of 12. Therefore, this study suggests that for children under 12 years of age, MFSCLs may be a preferred option for myopia control. For children over 12 years with high myopia, DIMS and MFSCLs demonstrate comparable efficacy and are both viable options. Additionally, previous studies have shown that initial SE can influence myopia progression.10–12 However, our findings indicate that in individuals already classified as having high myopia, myopia progression is no longer affected by SE but is instead influenced solely by the age at the time of intervention. This underscores the importance of early intervention. The absence of a relationship between the initial spherical equivalent and myopic progression suggests that each individual’s “final” amount of myopia that develops is unique. In other words, the initial presence of high myopia does not rule out the possibility of continued progression.

In summary, MFSCLs and DIMS both effectively limit myopic progression in highly myopic children aged 8–16. This study suggests that MFSCLs may be preferred for children under 12, while DIMS and MFSCLs show comparable efficacy for those over 12 with high myopia. Our findings suggest clinicians may choose appropriate lenses for children with high myopia to achieve ideal myopia control effects.