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Clinical Trials in Taiwan / NCT06200194
Active, not recruiting Phase 2

Early Intervention for Premyopic Children

NCT06200194 · tracked via the Priya Life Science Taiwan tracker
Phase
Phase 2
Started
2024-10-06
Last updated
2025-06-12

Condition(s) studied

MyopiaPreschool

Investigational drug(s) / intervention(s)

MiyoSmart Spectacles0.01% atropine →

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

Study 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 in premyopic children.

Eligibility

Sex
ALL
Min age
5 Years
Max age
6 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
National Yang Ming Chiao Tung University Hospital Yilan Taiwan

More National Yang Ming Chiao Tung University Hospital trials in Taiwan

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06200194 on ClinicalTrials.gov ↗ ← All trials in Taiwan