Early Intervention for High Risk Premyopic Children

With the increasing popularity of screen-based digital devices in the post-pandemic era, childhood myopia prevention and control has become a growing global challenge. Although the protective effect of increased outdoor time has been well established, the optimal strategy for preventing or delaying the onset of childhood myopia remains to be determined, particularly among pre-myopic children around the age of school entry. A substantial increase in myopia prevalence has been reported before and after entry into elementary school, and children with early-onset myopia are at increased risk of rapid progression and subsequent development of high myopia later in life.

Recent evidence suggests that low-concentration atropine eye drops may reduce the incidence of childhood myopia. However, photophobia and other dose-related adverse effects associated with higher concentrations of atropine may interfere with daytime visual activities and potentially reduce children's willingness to engage in outdoor activities. In addition, evidence regarding optical interventions for the prevention of myopia onset remains limited.

These unmet clinical needs motivate us to propose a randomized controlled trial evaluating optical and pharmacological approaches for myopia prevention using Defocus Incorporated Multiple Segments Triple Enhanced Design (DIMS TED) spectacle lenses and 0.025% atropine eye drops, respectively, in pre-myopic preschool children aged 5-6 years.

In this proposed study, we plan to recruit a total of 240 eligible participants identified as pre-myopic and asymptomatic through a population-based eye care program in Yilan County. Eligible participants will be randomly assigned to three groups: the DIMS TED spectacle lens group (n=80), the 0.025% atropine group (n=80), and the usual-care group (n=80).

Because environmental and near-work demands are generally lower during preschool than after entry into elementary school, children assigned to the DIMS TED group will be instructed to wear the spectacles using a stepwise strategy: primarily at home and during near-work activities during the preschool stage, followed by full-time wear after entering elementary school.

Cycloplegic spherical equivalent (SE) refraction and axial length will be measured every 6 months during the 7-year follow-up period. The primary outcome will be the change in mean cycloplegic SE over the study period among the three groups. Secondary outcomes will include the cumulative incidence of myopia, the cumulative proportion of participants exhibiting a fast myopic shift in SE, and changes in mean axial length over the study period.

This proposed project may provide further evidence regarding early optical and pharmacological intervention strategies for myopia prevention and may support the development of an eye-care model emphasizing early identification and intervention for pre-myopic preschool children before or around the time of elementary school entry.