The effect of individualized ocular refraction customized spectacle lenses on myopia control in schoolchildren: A 1-year randomised clinical trial

• Published in: Ophthalmic & physiological optics 2024-09, Vol.44 (6), p.1279-1289
• Main Authors: Lei, Si, Wu, Ye, Kou, Ji, Chen, Qian, Liu, Longqian
• Format: Article
• Language: English
• Subjects: Axial Length, Eye - physiopathology; Child; Clinical trials; Double-Blind Method; Elongation; Eye lens; Eyeglasses; Female; Humans; Male; Myopia; Myopia - physiopathology; Myopia - prevention & control; Myopia - therapy; Refraction; Refraction, Ocular - physiology; Treatment Outcome; Visual Acuity - physiology
• ISSN: 0275-5408; 1475-1313; 1475-1313
• DOI: 10.1111/opo.13354

The 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. This 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. After 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  0.05) 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