Myopia control efficacy of individualised ocular refraction customisation spectacle lenses: A 2-year follow-up study
摘要
To assess second-year myopia progression in children after a 1-year randomised controlled trial of individualised ocular refraction customisation (IORC) spectacle lenses, customised to each eye's peripheral refraction.
MethodsA total of 161 children were randomised to wear IORC lenses with high (+4.50 D, IORC-H), medium (+3.50 D, IORC-M) or low (+2.50 D, IORC-L) myopic defocus or single-vision lenses (SV). In year 2, all children received IORC-H, forming the IORC-H1/H2/H3/H4 groups, respectively. An external SV (eSV, n = 42) group was matched to year 2 baseline parameters. Spherical equivalent refraction (SER) and axial length (AL) were measured every 6 months.
ResultsCompared with the eSV group (12-month mean [SD] changes: SER −0.56 [0.44] D, AL 0.32 [0.16] mm), all IORC-H intervention groups demonstrated slower progression in year 2 (IORC-H1: −0.17 [0.37] D, 0.19 [0.14] mm; IORC-H2: −0.25 [0.41] D, 0.17 [0.16] mm; IORC-H3: −0.24 [0.36] D, 0.17 [0.14] mm; IORC-H4: −0.22 [0.40] D, 0.14 [0.17] mm; p < 0.05), with no intergroup differences (p > 0.05). Compared with the SV/eSV group, the IORC-H1 group presented 2-year reductions of 0.84 D and 0.38 mm in the SER and AL, respectively (p < 0.001) and exhibited minimal progression during the initial 0–6 months (p < 0.05), followed by constant progression over three subsequent 6-month intervals (p > 0.05).
ConclusionsSwitching to IORC-H in year 2 significantly reduced myopia progression and axial elongation. Maximal control efficacy occurred in the first 6 months, with sustained clinically meaningful effects thereafter.