Article Text
Abstract
Aims To report the 1-year results of the efficacy of a defocus distributed multipoint (DDM) lens in controlling myopia progression in a multicentre, randomised controlled trial.
Methods Overall, 168 children aged 6–13 years were recruited and randomly assigned to wear a DDM lens (n=84) or single-vision (SV) lens (n=84) in three centres. Cycloplegic autorefraction (spherical equivalent refraction (SER)) and axial length (AL) were measured. Linear mixed model analysis was performed to compare between-group SER and AL changes. Logistic regression analysis was used to analyse the between-group difference in rapid myopia progression (SER increase≥0.75 D per year or AL growth≥0.40 mm per year).
Results After 1 year, mean changes in SER were significantly lower in the DDM group (−0.47±0.37 D) than in the SV group (−0.71±0.42 D) (p<0.001). Similarly, mean changes in AL were significantly lower in the DDM group (0.21±0.17 mm) than in the SV group (0.34±0.16 mm) (p<0.001). After adjusting for age, sex, daily wearing time and parental myopia, rapid myopia progression risk was higher in the SV group than in the DDM group (OR=3.51, 95% CI: 1.77 to 6.99), especially for children who wore a lens for >12 hours per day, boys and younger children (6–9 years) with ORs (95% CIs) of 10.82 (3.22 to 36.37), 5.34 (1.93 to 14.78) and 8.73 (2.6 to 29.33), respectively.
Conclusions After 1 year, DDM lenses effectively retarded myopia progression in children. Longer daily wearing time of DDM lens improved the efficacy of myopia control. Future long-term studies are needed for validation.
Trial registration number NCT05340699.
- Clinical Trial
- Epidemiology
- Public health
- Prospective Studies
- Optics and Refraction
Data availability statement
Data are available upon reasonable request.
Statistics from Altmetric.com
Data availability statement
Data are available upon reasonable request.
Footnotes
XC and ML are joint first authors.
Contributors Concept and design: XC, ML, XG, LL and YanW; data acquisition and research execution: JL, MW, XL and CY; analysis and interpretation: YanboW, YansongW and WL; manuscript preparation and final approval: XC, ML, XG and YanW; and guarantor: LL and YanW.
Funding This study was funded by the National Natural Science Foundation of China (82271118) and Tianjin Key Medical Discipline (Specialty) Construction Project (TJYXZDXK-016A).
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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