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

tiistai 18. elokuuta 2026 päivittänyt: Foo Li Lian, Singapore National Eye Centre

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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

124

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi

Hyväksyy terveitä vapaaehtoisia

Joo

Kuvaus

Inclusion Criteria

Participants enrolled in the trial must:

  1. be accompanied by a parent or guardian who is able to read and comprehend English and sign a record of informed consent/assent;
  2. be able to understand and participate in the Assent process;
  3. at baseline, be within the age range of 6 to 12 years old inclusive;
  4. No prior spectacle correction
  5. Cycloplegic spherical equivalent (SE) 0.00 to + 2.00 D
  6. Astigmatism of less than -1.50D
  7. Anisometropia of not more than 1.50D
  8. 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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Huijausvertailija: Placebo
Participants will be provided with a pair of spectacles fitted with plano single vision lenses according to the assigned study intervention.
Laite: Single Vision Lenses
Patients will be fitted with a pair of plano single vision glasses.
Kokeellinen: Zeiss MyoActive Lenses
Participants will be provided with a pair of spectacles fitted with plano MyoActive lenses according to the assigned study intervention.
Laite: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Aikaikkuna
Change from baseline in axial length (mm) with ZEISS MyoActive spectacle lenses compared to single vision (SV) control lenses at 12 months.
Aikaikkuna: 12 months
12 months
Motivation to use myopia control interventions in carers of children with pre-myopia as assessed by motivation questionnaire at 12 months.
Aikaikkuna: 12 months
12 months
Compliance with ZEISS MyoActive spectacle lens wear in children with pre-myopia, as measured by patient reported questionnaire at 12 months
Aikaikkuna: 12 months
12 months
Change from baseline in choroidal thickness (µm) in children wearing ZEISS MyoActive spectacle lenses compared to single vision lenses at 12 months.
Aikaikkuna: 12 months
12 months
Number of participants with adverse events related to ZEISS MyoActive spectacle lens wear compared to single vision lenses at 12 months.
Aikaikkuna: 12 months
12 months
Adherence to ZEISS MyoActive spectacle lens wear compared to single vision lenses, as measured by patient reported questionnaire at 12 months.
Aikaikkuna: 12 months
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.
Aikaikkuna: 12 months
12 months

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Singapore National Eye Centre

Yhteistyökumppanit

Duke-NUS Graduate Medical School
ZEISS Vision Care

Julkaisuja ja hyödyllisiä linkkejä

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Yleiset julkaisut

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

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Ensisijainen valmistuminen (Arvioitu)

Sunnuntai 1. elokuuta 2027

Opintojen valmistuminen (Arvioitu)

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Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 30. heinäkuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 18. elokuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Perjantai 21. elokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 21. elokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 18. elokuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. heinäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 2025-2058

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Yhdysvalloissa valmistettu ja sieltä viety tuote

Ei

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