Effect of Wearing Peripheral Focus-out Glasses on Emmetropization in Chinese Children Aged 6-8 Years: Study Protocol For a 2-year, Randomized, Controlled Intervention Trial.

Abstract

Abstract Background Myopia is one of the most common eye diseases causing visual impairment and blindness, and the high prevalance in adolescents remains a major public health concern. Based on clinical studies using optical defocus to regulate ocular growth and refractive changes through visual feedback, we hypothesize that early wearing of peripheral myopic defocusing spectacles in children at high risk of myopia may slow the process of emmetropization and even prevent the onset of myopia by inducing more peripheral myopic defocus. The aim of this study is to investigate whether the wearing of peripheral focus-out glasses can be effective in delaying emmetropization in non-myopic children aged 6- 8 years. Methods The study is a 2-year, randomized, controlled trial. A total of 160 subjects will be randomized to the experimental or the control group. The experimental group will be fitted with Direct Emmetropia with Focus-out Glasses (DEFOG) to guide the emmetropization process. The control group will not receive any treatment and will serve as a blank control group. The primary aim is to determine whether non-myopic children wearing DEFOG lenses are superior to those who do not receive any intervention on progression of cycloplegic objective refraction over 2 years. Discussion This is the first randomized controlled trial aiming at myopic prevention by non-invasive intervention in non-myopic children. This study aims to initially investigate whether wearing peripheral focus-out glasses can effectively delay the process of emmetropization in children aged 6-8 year at high risk of myopia, which might give potential clues for further exploration on early prevention of myopia. Trial registration NCT05689567 (https://clinicaltrials.gov/ct2/manage-recs/register, registered on 10 January 2023).