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Randomized Clinical Trial of Diffusion Optics Technology Spectacle Lenses in a Chinese Population (CATHAY): 12-Month
Zhi Chen1, Xiao Yang2, Longqian Liu3
1Department of Ophthalmology and Vision Science, Fudan University Eye and ENT Hospital, Shanghai, China.
Objective:
To evaluate 12-month myopia control efficacy of diffusion optics technology (DOT) spectacle lenses in a Chinese population (CATHAY study).
Design:
Interim analysis of 6-month and 12-month data from a 24-month, randomized controlled clinical trial across 5 Chinese hospital sites, evaluating DOT spectacle lenses versus control standard single-vision (SV) spectacle lenses.
Participants:
One hundred ninety-five myopic children aged 6-13 years were enrolled across 5 sites in China. Participants were dispensed DOT lenses in a 2:1 ratio versus SV.
Methods:
Participants were randomized to DOT or SV spectacles. Axial length (AL) and cycloplegic spherical equivalent refraction (cSER) were measured at baseline, 6 months, and 12 months.
Main Outcome Measures:
Twelve-month changes in AL and cSER from baseline.
Results:
One hundred eighty-six children (DOT 128, SV 58) completed the 12-month visit (modified intent-to-treat cohort) with a mean age at prerandomization eligibility visit (baseline) of 9.6 ± 1.8 years. No severe adverse events were observed in either group. For DOT wearers, the mean observed change ± standard deviation in AL was 0.09 ± 0.22 (95% confidence interval [CI]: 0.05 to 0.13), and cSER change was -0.16 ± 0.51 D (95% CI: -0.25 to -0.07). For the SV group, mean observed change from baseline at 12 months for AL was 0.35 ± 0.19 mm (95% CI: 0.30-0.40), and cSER change was -0.64 ± 0.42 D (95% CI: -0.76 to -0.53). The least squares mean differences (±standard error) in AL elongation and cSER progression were significantly lower for DOT vs. SV at 12 months. The difference in AL change between DOT and SV was -0.26 ± 0.03 mm (P < 0.0001), and the difference in cSER progression for DOT versus SV was 0.48 ± 0.08 D (P < 0.0001).
Conclusions:
The 12-month interim results from this ongoing trial demonstrate the effectiveness of DOT spectacles for reducing myopic progression and axial elongation in Chinese children. A lens design based on the modulation of contrast on the retina works favorably for young Chinese children.
Financial Disclosures:
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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