Contact lenses with non‑refractive opaque features for paediatric myopia: a randomised, safety pilot trial

Most optical myopia-control strategies employ competing defocus, extended depth of focus, or light scatter to modulate ocular growth [ 1 ]. A daily disposable, single-vision soft contact lens incorporating non-refractive, light-absorbing, opaque features was developed to alter the spatiotemporal retinal luminance profile during natural eye movement without inducing defocus or blur [ 2 ]. Computational modelling [ 2 ] indicates such features generate distinct retinal ganglion cell firing patterns compared with conventional designs, and visual performance in adults was subjectively superior to a dual-focus lens [ 3 ]. In-vivo relevance for myopia control remains unknown. Experimental evidence raises concern that partial occlusion could potentiate myopiagenesis [ 4 ], underpinning the need for paediatric safety data before larger efficacy trials. This 14-month, three-phase, within-participant crossover pilot in myopic children assesses safety, feasibility, and explores axial-length signals with the proposed non-refractive lens design.