A Pilot Evaluation of Refractive Error Progression in Pre-Myopic Children in Singapore With and Without Myopia Control Spectacles

Overview

This study aims to find out whether ZEISS MyoActive lenses can help prevent short-sightedness from developing in children. We aim to recruit at least 50 children in total for this study. Myopia (short-sightedness) is becoming increasingly common in children worldwide. Early onset of myopia often leads to faster progression and a higher chance of developing high myopia, which increases the risk of serious eye conditions that can affect vision in adulthood, such as retinal detachment, glaucoma, and cataracts. Current treatments can slow the worsening of short-sightedness once children become myopic, but there is limited evidence on whether early intervention can delay myopia from developing in the first place. This study will compare two types of commonly used spectacle lenses: ZEISS MyoActive lenses, which are designed to provide a type of optical signal that may reduce the worsening of short-sightedness; and Standard single-vision lenses, which are the usual lenses prescribed for clear vision. Children who join the study will be randomly assigned to wear one of these two lens types for 12 months. They will attend regular check-ups during this time so we can monitor their eye health and vision. By randomly assigning children to one of these two lens types and following them over 12 months, we aim to determine whether ZEISS MyoActive lenses: reduce the likelihood of developing short-sightedness, slow changes in how short-sighted a child's eyes are becoming and eye growth, and are safe, comfortable, and well-tolerated for everyday use. The findings from this study may help improve early myopia prevention strategies and potentially reduce future risks of high myopia and its associated eye conditions.

Myopia is a 'global epidemic' owing to its rapid rise in prevalence across the world. Half of the world's population is expected to be myopic by the year 2050. Myopia significantly affects the quality of life of an individual and is an economic burden to both the individual and the society on account of the costs involved in living with myopia. In addition, high myopia increases the risk of ocular morbidity such as retinal detachment, cataract, glaucoma which could lead to blindness. Several optical and pharmaceutical strategies developed over the recent years have been shown to control or slow the progression of myopia. However, there remains a critical knowledge gap in our understanding of refractive error progression during the pre-myopic phase, a period that precedes the onset of clinically manifest myopia and may represent a key window for early intervention. As such, increasing attention has been directed towards identifying children at risk of developing myopia and implementing preventive strategies before myopia onset, including those summarized in the IMI interventions for controlling myopia onset. Although it has been reported that interventions in the pre-myopic phase can be successful in slowing refractive error shift, much work remains to understand ocular development during this phase, and particularly the needs and motivation of pre-myopic children and their carers. For example, since the eye is not yet myopic, this group may demonstrate lower compliance with any prescribed modality. Furthermore, given the young age of this cohort (commonly 4 to 6 years in East Asia), there may be specific requirements that need to be better understood. In particular, the potential role of myopia control spectacle lenses, as highlighted in the IMI recommendations, in influencing refractive development in pre-myopic children remains inadequately explored. Understanding whether such optical interventions can modify refractive trajectories in this at-risk population may have important implications for early myopia prevention strategies. HYPOTHESIS AND OBJECTIVES We hypothesise that pre-myopic children randomised to ZEISS MyoActive lenses will demonstrate a reduced rate of progression to clinical myopia, defined by cycloplegic spherical equivalent ≤ -0.50 D, compared with children wearing single-vision spectacle lenses over the study duration. Primary Objectives * To evaluate the change in cycloplegic objective spherical equivalent refractive error with ZEISS * MyoActive spectacle lenses compared to plano single vision (SV) spectacles over 12 months of wear. Secondary Objectives * To determine motivation to use of interventions to slow refractive error shift in carers of children with pre-myopia. • To evaluate the change in axial length with ZEISS MyoActive spectacle lenses compared to the SV control group over 12 months of lens wear. * To determine compliance to use of optical intervention to slow refractive error shift in children with pre-myopia. * To assess differences in choroidal thickness between children wearing ZEISS MyoActive lenses and those wearing SV. * To assess the safety, tolerability (quality of life (QoL)), and adherence to ZEISS MyoActive lens wear compared to SV in premyopic children.