Randomized clinical trial of Diffusion Optics Technology spectacle lenses in a Chinese population (CATHAY): 12-month results

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-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: 195 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 and 12 months (M).Main Outcome Measures: Twelve-month changes in AL and cSER from baseline.Results: 186 children (DOT 128, SV 58) completed the 12-month visit (modified intent to treat, mITT cohort) with a mean age at pre-randomization 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 SD in AL was 0.09 0.22 (95%CI: 0.05 to 0.13), and cSER change was -0.16 0.51D (95%CI: -0.25 to -0.07).For the SV group, mean observed change from baseline at 12M for AL was 0.35 0.19 mm (95%CI: 0.30 to 0.40) and cSER change was -0.64 0.42D (95%CI: -0.76 to -0.53).The least squares mean (LSM) differences ( SE) in AL elongation and cSER progression were significantly lower for DOT versus SV at 12M.The difference in AL change between DOT and SV was -0.26 0.03mm (p<0.0001), and the difference in cSER progression for DOT versus SV was 0.48 0.08D (p<0.0001). Conclusions:The 12M 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.