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MyopiaPhase 2NCT06200194

Early Intervention for Premyopic Children

A Phase 2 study testing MiyoSmart Spectacles and 0.01% atropine in people with Myopia and Preschool, run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this research project is to add evidence of pharmacological (0.01% atropine) and optical (Defocus Integrated Multiple Segments spectacle lenses) approaches for myopia prevention among premyopic preschoolers, which may contribute to a better understanding of the intervention strategy for myopia control… Read more about this study

Who is it for?
Ages 5 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Myopia, Preschool
What is being tested?
MiyoSmart Spectacles and 0.01% atropine
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteTaiwan
Study dates
6 Oct 2024to Jul 2026
Phase
Phase 2
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 5 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age at enrollment: 5-6 years old (the senior grade of kindergarten)
  • Cycloplegic SE of the eye with less SE (less positive or more negative refractive error): < +1.00 D and > -0.50 D
  • Astigmatism: 1.0 D or less in both eyes
  • Anisometropia: 1.50 D or less
  • Monocular uncorrected visual acuity: 6/7.5 or better in both eyes
  • Either of the parents with moderate myopia
  • Acceptance of random group allocation
  • Submission of complete informed consent.

Who cannot join

  • Strabismus or any ocular motility disorder
  • Any ophthalmic and systemic disorders that might affect visual functions or refractive development
  • Previous treatment of atropine or other myopia control intervention

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Yang Ming Chiao Tung University Hospital

    Yilan, Taiwan, 26058

Other trials in Taiwan

About this study

Official title: Early Intervention for Premyopic Children: A Comparison Study of Defocus Integrated Multiple Segments Spectacle Lenses, 0.01% Atropine and Usual Care for Myopia Prevention

The purpose of this research project is to add evidence of pharmacological (0.01% atropine) and optical (Defocus Integrated Multiple Segments spectacle lenses) approaches for myopia prevention among premyopic preschoolers, which may contribute to a better understanding of the intervention strategy for myopia control in premyopic children.

Read the detailed description

With more popularity of screen-based digital devices in the post-pandemic era, childhood myopia prevention and control has encountered a tough challenge on a global scale. Though the protective effect of spending more time outdoors has been well proven, the optimal practice for preventing or delaying the early onset of childhood myopia still needs further investigations, particularly in pre-myopic children around the school entrance age. It has been reported that there is a double-digit increase in myopia prevalence before and after elementary school entry, and young children with early-onset myopia are at great risk of rapid progression to high myopia later in life. Most recently, nightly use of 0.05% atropine eye drops is effective in reducing the incidence of childhood myopia. However, photophobia is a common adverse effect of higher concentration atropine, which may hinder children from daytime outdoor activities. Besides, little is known about the optical approach for myopia prevention in the existing literature. These unmet demands in clinical practice motivate us to propose a randomized controlled trial on myopia prevention with optical (Defocus Incorporated Multiple Segments [DIMS] spectacle lenses) or pharmacological (0.01% atropine eye drops) modalities among pre-myopic preschoolers aged 5-6 years. To explore the adaptability and feasibility of DIMS spectacle lenses for pre-myopic children with normal visual acuity, we have conducted a pilot study and revealed that all 24 subjects can tolerate daily full-time wearing of DIMS spectacle lenses without significant visual complaints. In this proposal, we plan to recruit a total of 234 eligible participants who have been identified as pre-myopic and asymptomatic in a population-based eye care program in Yilan County. Eligible subjects will be randomly assigned to the DIMS spectacles (n=78), 0.01% atropine (n=78), and usual care (n=78) groups. Less environmental pressure is hypothesized in preschool compared with elementary school. Hence, pre-myopic children will be asked to wear DIMS spectacle lenses in a stepwise pattern: at-home wearing in the preschool stage and full-time in the elementary school stage. Cycloplegic spherical equivalent (SE) refraction and axial length will be measured every 3 months over the 18-month follow-up period. The primary outcome is the changes in mean cycloplegic SE over the study period in each group. The secondary outcomes include the cumulative percentage of incident myopia, the cumulative percentage of a fast myopic shift of SE, and the changes in mean axial length over the study period in each group. This proposed project may offer insight into the intervention strategy for myopia prevention and evoke the possibility of a reinvented eye care policy that may focus on early identification and intervention for pre-myopic preschoolers.

Conditions
Myopia, Preschool
Being tested
MiyoSmart Spectacles, 0.01% atropine
Medical subject headings
Myopia

What participants receive

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

  • MiyoSmart SpectaclesDevice

    Also called MiyoSmart (Hoya, Tokyo, Japan)

    No power in the central optic zone of DIMS lens for premyopic children with normal vision. Before entering elementary school, eligible preschoolers are asked to wear the DIMS spectacles after kindergarten hours and during weekends and holidays. After entering elementary school, full-time mode wearing of DIMS spectacles is required.

  • 0.01% atropineDrug

    Also called "AIM" Atropine Eye Drops 0.01% (AIMedicine, Taipei, Taiwan)

    daily use of non-preservative 0.01% atropine eye drop for each eye over the study period.

Study groups in NCT06200194
Study groupRoleWhat they receive
DIMS lensExperimentalDIMS spectacle lenses. Daily wear for 1.5 years.
Receives: Device: MiyoSmart Spectacles
0.01% AtropineExperimental0.01% Atropine. One drop per eye, per day, for 1.5 years.
Receives: Drug: 0.01% atropine
Usual careNo interventionUsual care including promoting outdoor time

What is being measured

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

  1. Myopic shift of spherical equivalent refraction

    The change of mean cycloplegic spherical equivalent refraction over 1.5 years

    Measured: 18 months

Secondary outcomes (3)
  1. Axial length elongation

    The change of mean axial length over 1.5 years

    Measured: 18 months

  2. Incidence of myopia

    the cumulative percentage of incident myopia

    Measured: 18 months

  3. Fast myopic shift of spherical equivalent refraction

    the cumulative percentage of fast myopic shift of spherical equivalent refraction

    Measured: 18 months

Timeline

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

  1. First posted10 Jan 2024
  2. Study start6 Oct 2024
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06200194
Sponsor's protocol ID
NYCUH2023A018
Status last verified
Jun 2025
First submitted
28 Dec 2023
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang HY, Tsai DC, Yang YC, Wang CY, Lee CW, Huang PW. Efficacy of defocus incorporated multiple segments (DIMS) lenses and low-dose atropine on retarding myopic shift among premyopic preschoolers: Protocol for a prospective, multicenter, randomized controlled trial. PLoS One. 2024 Dec 31;19(12):e0312935. doi: 10.1371/journal.pone.0312935. eCollection 2024.

    PubMed 39739826

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MiyoSmart Spectacles and 0.01% atropine in people with Myopia and Preschool, run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.

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 8 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2025. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myopic shift of spherical equivalent refraction (time frame: 18 months). 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 NCT06200194, which also lists 1 linked publication.

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 12 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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