Affiliation:
1. Department of Ophthalmology West China Hospital of Sichuan University Chengdu Sichuan China
2. Department of Optometry and Vision Science, West China School of Medicine Sichuan University Chengdu Sichuan China
3. Center of Biostatistics, Design, Measurement and Evaluation, Department of Clinical Research Management, West China Hospital Sichuan University Chengdu Sichuan China
4. Laboratory of Optometry and Vision Sciences, West China Hospital Sichuan University Chengdu Sichuan China
Abstract
AbstractPurposeThe aim of this study was to investigate the effect of individualized ocular refraction customized (IORC) spectacle lenses with different actual amounts of peripheral myopic defocus (MD) on myopia control over 1 year. These lenses compensate for the original peripheral refraction via the free‐form surface on the back of the lens.MethodsThis 1‐year, double‐masked randomised clinical trial included 184 myopic schoolchildren aged 8–12 years. Participants were randomised to receive IORC lenses with high (IORC‐H group, +4.50 D), medium (IORC‐M group, +3.50 D) or low (IORC‐L group, +2.50 D) MD or single‐vision (SV) lenses. The spherical equivalent refractive error (SER) and axial length (AL) were measured at baseline and 6‐monthly intervals.ResultsAfter 1 year, the mean (SD) changes in SER were −0.18 (0.37), −0.36 (0.37), −0.52 (0.39) and −0.60 (0.42) D for the IORC‐H, IORC‐M, IORC‐L and SV groups, respectively. Compared with the SV group, the effects of slowing myopia progression were 70%, 40% and 13% for the IORC‐H (difference of 0.47 D, p < 0.001), IORC‐M (difference of 0.32 D, p = 0.001) and IORC‐L (difference of 0.15 D, p > 0.05) groups, respectively. The mean (SD) changes in AL were 0.12 (0.16), 0.23 (0.17), 0.29 (0.17) and 0.36 (0.17) mm for the IORC‐H, IORC‐M, IORC‐L and SV groups, respectively. The axial elongation was 67%, 36% and 19% lower in the IORC‐H (difference of 0.25 mm, p < 0.001), IORC‐M (difference of 0.15 mm, p < 0.001) and IORC‐L (difference of 0.10 mm, p = 0.04) groups, respectively, compared with the SV group. The IORC‐H group exhibited significantly less axial elongation than the IORC‐M and IORC‐L groups (p = 0.01 and p < 0.001, respectively).ConclusionCompared with the IORC‐M and IORC‐L lenses, the IORC‐H lens was found to have superior efficacy in inhibiting myopic progression and slowing eye growth in schoolchildren, with better myopia control efficacy in younger children.