Evaluating the effect of a new myopia control spectacle lens among children in Israel: 24-month results

AIM: To investigate the effectiveness of a novel spectacle lens designed to slow the progression of myopia in children. METHODS: In this prospective clinical trial, children aged 6-13 years (N = 126) with spherical equivalent (SER) refractive errors of -0.5 to -6.25 dioptres (D) were randomised into either the Shamir Myopia Control (SMC) lens group or single-vision spectacle lenses (SVL) groups. Outcome measures were changes in axial length (AL), SER, and subjective rating of visual experience (SVE). RESULTS: After 24 months, AL elongation in the SMC group (N:38) was slowed by 33%, while SER progression was slowed by 26% compared to SVL (N:37, p < 0.05). In the SMC younger subgroup (6-10 years), AL elongation was slowed by 0.28 mm (44%, p < 0.001) while SER progression was slowed by 0.53 D (43%, p < 0.05). In the SMC subgroup with 2 myopic parents, AL elongation was slowed by 0.18 mm (p < 0.001) while SER progression was slowed by 0.55 D (43%, p < 0.001). SVE reported in a 24-month questionnaire revealed no difference between the SMC and SVL groups. The average daily wearing hours reported in 24 months were similar in the SMC and SVL groups: 14.7 and 14.9 h, respectively. CONCLUSION: After 24 months of continuous wear, the SMC lens was proven to be effective in slowing the progression of myopia, especially in children younger than 10 years and in children with two myopic parents. SVE and the prolonged daily use reported by the SMC group indicated good lens tolerability.