A randomized clinical trial on the effectiveness of plano spectacle lenses with lenslets on myopia prevention in pre-myopic children: Study protocol of a randomized controlled trial.

Abstract

Purpose: Myopia is a growing concern in children worldwide, leading to significant visual impairments. This study investigates the efficacy of plano spectacle lenses with lenslets in preventing the onset of myopia in pre-myopic children. This study aims to contribute to the development of evidence-based strategies for myopia prevention by assessing compliance, efficacy and safety of plano spectacle lenses with lenslets.

Methods: This randomized controlled trial involves 388 pre-myopic children aged 6-9 years. Participants are randomly assigned to either the intervention group, using plano spectacle lenses with lenslets for at least 8 h daily with smart frames recording wearing time, or the control group, which receives no intervention. The primary outcome is the 1-year cumulative incidence of myopia. Secondary outcomes include changes in spherical equivalent under cycloplegia, axial length, choroidal thickness, visual acuity and accommodation function over the study period. Statistical analyses, including chi-squared tests and t-tests, will evaluate these outcomes.

Discussion: This study will offer valuable insights into the use of plano spectacle lenses with lenslets in slowing down the progression to myopia in children at risk. Findings are expected to inform clinical practices and shape guidelines for myopia prevention strategies among the paediatric population.

Trial registration: NCT06860737.