RESUMEN
PURPOSE: To investigate the effectiveness of a novel spectacle lens designed to slow the progression of myopia in children. DESIGN: A prospective, randomized, double blind clinical trial. METHODS: One hundred twenty-six Israeli children aged 6-13 years with spherical equivalent (SER) refractive errors of -0.5 to -6.25 diopters (D) were randomized into either the Shamir Myopia Control (SMC) lens design group or the conventional single-vision spectacle lenses (SVL), the control group. Outcomes measured were changes in axial length and cycloplegic refraction as well as subjective rating of visual experience over a period of 12 months. RESULTS: At 12 months, AL and SER progression were slowed by 0.11 mm (35%, P < .05) and 0.16 D (25%, P = .122), respectively. In the subgroup of 6-10-year-olds, AL and SER progression were slowed by 0.17 mm (41%, P < .05) and 0.31 D (43%, P < .05), respectively. Similarly, for the subgroup of children with 2 myopic parents AL and SER progression were slowed by 0.15 mm (45% P < .05) and 0.36 D (42%, P < .05), respectively. Subjective visual experience reported in the 12-month questionnaire revealed no difference between the SMC and SVL groups, and average daily wearing hours were also not different between the groups: 14 (±1.4) and 13.8 (±2.3) hours, respectively. The study continues to its second year. CONCLUSIONS: SMC lenses were effective in slowing the progression of SER and AL, especially for younger children and those having 2 myopic parents. The subjective rating of visual experience and the daily duration of use reported by the SMC group at 12 months were similar to the control group, indicating good lens tolerability.