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

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.

Inclusion criteria

Participants enrolled in the trial must:

• be accompanied by a parent or guardian who is able to read and comprehend English and sign a record of informed consent/assent;
• be able to understand and participate in the Assent process;
• at baseline, be within the age range of 6 to 12 years old inclusive;
• No prior spectacle correction
• Cycloplegic spherical equivalent (SE) 0.00 to + 2.00 D
• Astigmatism of less than -1.50D
• Anisometropia of not more than 1.50D
• At least 1 parent or more with myopia

Exclusion criteria

Participants enrolled in the trial must NOT have:

• Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error;
• Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus.
• Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the study. NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the study product is used.
• History of eye trauma
• Amblyopia
• Strabismus
• History of any form of optical correction
• Any concomitant myopia control treatment including atropine eyedrops, contact lenses or other myopia control glasses.

The Investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the study requirements or it is believed to be in the participant's best interests.