Background
Myopia has reached epidemic proportions globally, with particularly rapid progression in pediatric populations. Axial elongation remains the primary biomarker for myopia progression, correlating strongly with future vision-threatening complications. While Defocus Incorporated Multiple Segments (DIMS) lenses have demonstrated efficacy in clinical trials, this real-world study provides the first multicenter comparison of next-generation Diversified Segmental Defocus Optimization (DSDO) lenses against both DIMS technology and natural history controls.
Study Design
Population and Interventions
This prospective study enrolled 1541 participants across eight Aier Eye Hospital Group centers in China, stratified into myopic (n=1315) and non-myopic (n=226) cohorts. The intervention arms included: DSDO lenses (myopic: n=654; non-myopic: n=85), DIMS lenses (myopic: n=661), and untreated controls (non-myopic: n=141). Propensity score matching ensured balanced baseline characteristics including age, sex, spherical equivalent (SE), and axial length (AL).
Methodological Rigor
The study implemented standardized AL measurements using the Haag-Streit Lenstar at baseline, 6 and 12 months. Treatment efficacy was analyzed through repeated measures ANCOVA with post-hoc Bonferroni correction. Subgroup analyses examined age stratification (≤10 vs >10 years), baseline SE, and AL quartiles.
Key Findings
Superiority in Myopia Control
DSDO lenses demonstrated statistically significant reduction in AL elongation compared to DIMS lenses at both 6 months (0.07±0.12mm vs 0.09±0.10mm, P=0.026) and 12 months (0.17±0.18mm vs 0.19±0.16mm, P=0.019). The treatment effect appeared most pronounced in younger children (≤10 years) with low myopia (SE ≤ -3.00D), showing 42% greater AL control (P=0.001). Notably, baseline AL emerged as an independent predictor of subsequent elongation (β=0.31, P<0.001).
Prophylactic Potential in Non-Myopes
The non-myopic cohort revealed DSDO lenses suppressed physiological AL growth by 38% compared to untreated controls at 12 months (0.18±0.14mm vs 0.29±0.14mm, P=0.01). This protective effect was most evident in hyperopic/emmetropic children (0.00 < SE ≤1.50D), with 62% greater efficacy (P=0.004).
Clinical Implications
The time-dependent treatment response suggests an opportunity window for early intervention, with 72% of DSDO’s annual treatment effect occurring within the first 6 months. Differential efficacy across refractive subgroups supports personalized prescription strategies based on age and baseline refractive status. The non-myopia findings warrant further investigation into preventive applications before myopia onset.
Limitations
This real-world study maintained strong internal validity through propensity matching but was limited to 12-month follow-up. Future research should evaluate long-term durability of treatment effects and ocular safety parameters beyond AL. The Chinese population focus necessitates confirmation of results in diverse ethnic groups.
Conclusion
DSDO lenses represent an advancement in optical myopia control, demonstrating superiority over DIMS technology while establishing potential for physiological axial growth modulation in pre-myopic children. These findings support early, risk-stratified intervention paradigms in pediatric myopia management.