Diffractive optical element (D.O.E) spectacle lenses for myopia prevention and control: a small-scale pilot study among younger Chinese children.

AIM: To assess the efficacy and safety of diffractive optical element (D.O.E) spectacle lenses in reducing the incidence and progression of myopia compared with currently available myopia control spectacle lenses in younger Chinese children.

METHODS

This randomised, investigator-masked, parallel-controlled, small-scale pilot study included participants aged 6-8 years with a spherical equivalent refraction (SER) between 0.00 D and -1.75 D in either eye. Additionally, astigmatism and anisometropia did not exceed 1.50 D. Participants were randomly assigned to wear either the D.O.E (n=19) or highly aspherical lenslets ((H.A.L.T), n=17) spectacle lenses. Axial length (AL), choroidal thickness (ChT) and cycloplegic SER were measured at baseline and at 1, 2 and 3 months after wearing the spectacle lenses. Changes in AL, ChT and cycloplegic SER between the two groups were analysed using linear mixed models. Differences in compliance and subjective evaluations were also assessed.

RESULTS

After 3 months, compared with the H.A.L.T group, the D.O.E group exhibited significantly smaller changes in cycloplegic SER (p<0.001), a significant reduction in AL (p=0.024) and a significantly greater increase in ChT (p=0.009). The estimated least-squares mean differences (95% CIs) compared with the H.A.L.T group were as follows: cycloplegic SER, 0.197 (0.068 to 0.326) D; AL, -0.027 (-0.072 to 0.018) mm; and ChT, 11.098 (0.067 to 22.130) μm. No significant differences were observed between the groups regarding compliance or subjective evaluation.

CONCLUSIONS

D.O.E spectacle lenses used in this pilot study demonstrated a statistically significant, though not clinically meaningful, effect in slowing myopia progression among younger Chinese children. The primary limitations were the small sample size and the short observation period, which restricted the ability to detect clinically significant changes. These findings are preliminary and require further validation before they can inform clinical decision-making.

TRIAL REGISTRATION NUMBER: NCT06927414.