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MyopiaNCT07779941

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

A study testing Zeiss MyoActive lenses and Single Vision Lenses in people with Myopia and Pre-myopia, run by Singapore National Eye Centre at 1 site in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Myopia, Pre-myopia
What is being tested?
Zeiss MyoActive lenses and Single Vision Lenses
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
1 siteSingapore
Study dates
Aug 2026to Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 9Show fewer
  • Astigmatism of less than -1.50D
  • Anisometropia of not more than 1.50D
  • At least 1 parent or more with myopia

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Singapore1 site
  • Singapore National Eye Centre

    Singapore

    Dr Foo Li Lian, +6596572880, foo.li.lian@singhealth.com.sg

Other trials in Singapore

About this study

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.

Read more

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.

Read the detailed description

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.
Conditions
Myopia, Pre-myopia
Being tested
Zeiss MyoActive lenses, Single Vision Lenses
Keywords
myopia, pre-myopia
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zeiss MyoActive lensesDevice

    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.

  • Single Vision LensesDevice

    Patients will be fitted with a pair of plano single vision glasses.

Study groups in NCT07779941
Study groupRoleWhat they receive
PlaceboSham comparatorParticipants will be provided with a pair of spectacles fitted with plano single vision lenses according to the assigned study intervention.
Receives: Device: Single Vision Lenses
Zeiss MyoActive LensesExperimentalParticipants will be provided with a pair of spectacles fitted with plano MyoActive lenses according to the assigned study intervention.
Receives: Device: Zeiss MyoActive lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cycloplegic objective spherical equivalent refractive error (dioptres) with ZEISS MyoActive spectacle lenses compared to plano single vision (SV) spectacles at 12 months.

    Measured: 12 months of wear

Secondary outcomes (7)
  1. Change from baseline in axial length (mm) with ZEISS MyoActive spectacle lenses compared to single vision (SV) control lenses at 12 months.

    Measured: 12 months

  2. Motivation to use myopia control interventions in carers of children with pre-myopia as assessed by motivation questionnaire at 12 months.

    Measured: 12 months

  3. Compliance with ZEISS MyoActive spectacle lens wear in children with pre-myopia, as measured by patient reported questionnaire at 12 months

    Measured: 12 months

  4. Change from baseline in choroidal thickness (µm) in children wearing ZEISS MyoActive spectacle lenses compared to single vision lenses at 12 months.

    Measured: 12 months

  5. Number of participants with adverse events related to ZEISS MyoActive spectacle lens wear compared to single vision lenses at 12 months.

    Measured: 12 months

  6. Adherence to ZEISS MyoActive spectacle lens wear compared to single vision lenses, as measured by patient reported questionnaire at 12 months.

    Measured: 12 months

  7. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07779941
Sponsor's protocol ID
2025-2058
Status last verified
Jul 2026
First submitted
30 Jul 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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

Publications

  • Wildsoet CF, Chia A, Cho P, Guggenheim JA, Polling JR, Read S, Sankaridurg P, Saw SM, Trier K, Walline JJ, Wu PC, Wolffsohn JS. IMI - Interventions Myopia Institute: Interventions for Controlling Myopia Onset and Progression Report. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M106-M131. doi: 10.1167/iovs.18-25958.

    PubMed 30817829
  • Bullimore MA, Saunders KJ, Baraas RC, Berntsen DA, Chen Z, Chia AWL, Goto S, Jiang J, Lan W, Logan NS, Najjar RP, Polling JR, Read SA, Woodman-Pieterse EC, Szell N, Verkicharla PK, Wu PC, Zhu X, Loughman J, Nagra M, Phillips JR, Tran HDM, Vera-Diaz FA, Yam J, Liu YM, Singh SE, Wildsoet CF. IMI-Interventions for Controlling Myopia Onset and Progression 2025. Invest Ophthalmol Vis Sci. 2025 Sep 2;66(12):39. doi: 10.1167/iovs.66.12.39.

    PubMed 40960225
  • Sankaridurg P, Berntsen DA, Bullimore MA, Cho P, Flitcroft I, Gawne TJ, Gifford KL, Jong M, Kang P, Ostrin LA, Santodomingo-Rubido J, Wildsoet C, Wolffsohn JS. IMI 2023 Digest. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):7. doi: 10.1167/iovs.64.6.7.

    PubMed 37126356
  • Sankaridurg P, Tahhan N, Kandel H, Naduvilath T, Zou H, Frick KD, Marmamula S, Friedman DS, Lamoureux E, Keeffe J, Walline JJ, Fricke TR, Kovai V, Resnikoff S. IMI Impact of Myopia. Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):2. doi: 10.1167/iovs.62.5.2.

    PubMed 33909036
  • Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

    PubMed 26875007

Questions about this trial

What is this clinical trial studying?

A study testing Zeiss MyoActive lenses and Single Vision Lenses in people with Myopia and Pre-myopia, run by Singapore National Eye Centre at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dr Foo Li Lian (+6596572880, foo.li.lian@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07779941, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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Clinical Trial NCT07779941 | AzTrials