Novel Lenslet-ARray-Integrated Spectacle Lenses for Myopia Control: A 1-Year Randomized, Double-Masked, Controlled Trial.

ABSTRACT

PURPOSE: To investigate the myopia control efficacy of novel Lenslet-ARray-Integrated (LARI) spectacle lenses with positive power lenslets (PLARI) and negative power lenslets (NLARI) worn for 1 year in myopic children. DESIGN: Randomized, double-masked, controlled clinical trial. PARTICIPANTS: A total of 240 children 6 to 12 years of age with spherical equivalent refraction (SER) between -4.00 and -1.00 diopters (D), astigmatism of ≤ 1.50 D, and anisometropia of ≤ 1.00 D. METHODS: Participants were assigned randomly in a 111 ratio to PLARI, NLARI, and control (single-vision [SV]) groups. Cycloplegic autorefraction and axial length were measured at baseline and 6-month intervals after lens wear. MAIN OUTCOME MEASURES: Changes in SER, axial elongation (AE), and differences between groups. RESULTS: After 1 year, SER changes and AE in the PLARI and NLARI groups were significantly less than those in the SV group (SER -0.30 ± 0.48 D, -0.21 ± 0.35 D, and -0.66 ± 0.40 D, respectively; AE 0.19 ± 0.20 mm, 0.17 ± 0.14 mm, 0.34 ± 0.18 mm, respectively; all P < 0.001). No significant differences were found in SER changes and AE between PLARI and NLARI groups (P = 0.54 and P = 1.00, respectively). Younger age was associated with more rapid SER increase and larger AE in the SV group (r = 0.40 [P < 0.001] and r = -0.59 [P < 0.001], respectively) and PLARI group (r = 0.46 [P < 0.001] and r = -0.52 [P < 0.001], respectively), but not in the NLARI group (r = -0.002 [P = 0.98] and r = -0.08 [P = 0.48], respectively). CONCLUSIONS: Compared with the SV group, both PLARI and NARI groups showed significantly slower myopia progression in terms of SER and AE. Faster myopia progression, in terms of both SER and AE, was associated with younger age in the SV and PLARI groups but not the NLARI group. FINANCIAL DISCLOSURE(S) Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.