Trial reportBMJ open ophthalmology2026
Diffractive optical element (D.O.E) spectacle lenses for myopia prevention and control: a small-scale pilot study among younger Chinese children.
Trial report in BMJ open ophthalmology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06927414 (Exploratory Study on the Effectiveness and Safety of Light Diffraction Frame Glasses in Preventing and Controlling Myopia in Children and Adolescents), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Exploratory Study on the Effectiveness and Safety of Light Diffraction Frame Glasses in Preventing and Controlling Myopia in Children and Adolescents
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo 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.
methodsThis 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.
resultsAfter 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.
conclusionsD.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.
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