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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 124 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Singapore National Eye Centre is the lead sponsor of 87 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
PDFs hosted by the registry, ClinicalTrials.gov.
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
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 12 months is below that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Singapore National Eye Centre