An interventional study of Zeiss MyoActive lenses and Single Vision Lenses in Myopia and Pre-myopia, sponsored by Singapore National Eye Centre. Not yet recruiting at 1 site in Singapore. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Singapore National Eye Centre · Not applicable, Interventional, and Prevention
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
Secondary Objectives
To determine motivation to use of interventions to slow refractive error shift in carers of children with pre-myopia.
To determine compliance to use of optical intervention to slow refractive error shift in children with pre-myopia.
Participants enrolled in the trial must:
Exclusion Criteria
Participants enrolled in the trial must NOT have:
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.
Participants will be provided with a pair of spectacles fitted with plano single vision lenses according to the assigned study intervention.
Device: Single Vision Lenses
Participants will be provided with a pair of spectacles fitted with plano MyoActive lenses according to the assigned study intervention.
Device: Zeiss MyoActive lenses
The novel ZEISS MyoActive lens was designed to introduce simultaneous myopic defocus at the retina. Early studies, including interim results from the ongoing trial NCT06563700, have shown promise in reducing myopia progression in already-myope children. However, its utility in pre-myopic children remains underexplored, and no current optical strategy has been validated for delaying the transition from pre-myopia to clinical myopia.
Patients will be fitted with a pair of plano single vision glasses.
Change in cycloplegic objective spherical equivalent refractive error (dioptres) with ZEISS MyoActive spectacle lenses compared to plano single vision (SV) spectacles at 12 months.
Time frame: 12 months of wear
Change from baseline in axial length (mm) with ZEISS MyoActive spectacle lenses compared to single vision (SV) control lenses at 12 months.
Time frame: 12 months
Motivation to use myopia control interventions in carers of children with pre-myopia as assessed by motivation questionnaire at 12 months.
Time frame: 12 months
Compliance with ZEISS MyoActive spectacle lens wear in children with pre-myopia, as measured by patient reported questionnaire at 12 months
Time frame: 12 months
Change from baseline in choroidal thickness (µm) in children wearing ZEISS MyoActive spectacle lenses compared to single vision lenses at 12 months.
Time frame: 12 months
Number of participants with adverse events related to ZEISS MyoActive spectacle lens wear compared to single vision lenses at 12 months.
Time frame: 12 months
Adherence to ZEISS MyoActive spectacle lens wear compared to single vision lenses, as measured by patient reported questionnaire at 12 months.
Time frame: 12 months
Change from baseline in quality of life scores in children wearing ZEISS MyoActive spectacle lenses compared to single vision lenses, as assessed by tolerability questionnaire at 12 months.
Time frame: 12 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — In accordance with the Personal Data Protection Act (PDPA) of Singapore, individual participant data (IPD) will not be made available for sharing. All data collected in this study will be managed and protected in compliance with applicable Singapore data protection regulations
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Singapore National Eye Centre