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.
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
- 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
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.
- 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 group | Role | What they receive |
|---|---|---|
| DIMS lens | Experimental | DIMS spectacle lenses. Daily wear for 1.5 years. Receives: Device: MiyoSmart Spectacles |
| 0.01% Atropine | Experimental | 0.01% Atropine. One drop per eye, per day, for 1.5 years. Receives: Drug: 0.01% atropine |
| Usual care | No intervention | Usual care including promoting outdoor time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myopic shift of spherical equivalent refraction
The change of mean cycloplegic spherical equivalent refraction over 1.5 years
Measured: 18 months
Secondary outcomes (3)
Axial length elongation
The change of mean axial length over 1.5 years
Measured: 18 months
Incidence of myopia
the cumulative percentage of incident myopia
Measured: 18 months
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.
- First posted10 Jan 2024
- Study start6 Oct 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Der-Chong Tsai, MD PhD, National Yang Ming Chiao Tung University Hospital
- Investigators
- Der-Chong Tsai, MD, PhD, Principal investigator, National Yang Ming Chiao Tung University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06200194
- Acronym / sponsor ID
- NYCUH2023A018
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 6 Oct 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DIMS lens | Experimental | Device: MiyoSmart SpectaclesDIMS spectacle lenses. Daily wear for 1.5 years. |
| 0.01% Atropine | Experimental | Drug: 0.01% atropine0.01% Atropine. One drop per eye, per day, for 1.5 years. |
| Usual care | No intervention | –Usual care including promoting outdoor time |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiyoSmart SpectaclesAlso: 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. | Device | DIMS lens |
| 0.01% atropineAlso: "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. | Drug | 0.01% Atropine |
Primary outcome
Myopic shift of spherical equivalent refraction
Time frame: 18 months
The change of mean cycloplegic spherical equivalent refraction over 1.5 years
3 secondary outcomes
Axial length elongation
Time frame: 18 months
Incidence of myopia
Time frame: 18 months
Fast myopic shift of spherical equivalent refraction
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 39739826Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Der-Chong Tsai, MD, PhD principal investigator
National Yang Ming Chiao Tung University Hospital
1 site in 1 country: see every site and its status.
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.