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This multicenter US randomized clinical trial compared highly aspherical lenslet (HAL) spectacles with single-vision lenses in children aged 6 to 12 years with myopia.
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The trial was double-masked, randomized participants 1:1, and stratified assignment by site, age group, and baseline myopia severity.
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The prespecified 24-month analysis assessed changes from baseline in cycloplegic spherical equivalent refraction and axial length; the trial’s primary end point is at 36 months.
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HAL lenses combine a single-vision correction zone with 11 contiguous rings of highly aspherical lenslets designed to create myopic defocus anterior to the retina.
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The study assessed safety through adverse events, visual acuity, and symptoms, problems, and complaints, and instructed participants to wear study spectacles at least 10 hours daily on 6 days each wee
