NCT06200194

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
2mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Oct 2024Jul 2026

First Submitted

Initial submission to the registry

December 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

October 6, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1.7 years

First QC Date

December 28, 2023

Last Update Submit

June 9, 2025

Conditions

MyopiaPreschool

Outcome Measures

Primary Outcomes (1)

  • Myopic shift of spherical equivalent refraction

    The change of mean cycloplegic spherical equivalent refraction over 1.5 years

    18 months

Secondary Outcomes (3)

  • Axial length elongation

    18 months

  • Incidence of myopia

    18 months

  • Fast myopic shift of spherical equivalent refraction

    18 months

Study Arms (3)

DIMS lens

EXPERIMENTAL

DIMS spectacle lenses. Daily wear for 1.5 years.

Device: MiyoSmart Spectacles

0.01% Atropine

EXPERIMENTAL

0.01% Atropine. One drop per eye, per day, for 1.5 years.

Drug: 0.01% atropine

Usual care

NO INTERVENTION

Usual care including promoting outdoor time

Interventions

MiyoSmart SpectaclesDEVICE

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.

Also known as: MiyoSmart (Hoya, Tokyo, Japan)
DIMS lens
0.01% atropineDRUG

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

Also known as: "AIM" Atropine Eye Drops 0.01% (AIMedicine, Taipei, Taiwan)
0.01% Atropine

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University Hospital

Yilan, Taiwan, 26058, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 39739826DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Der-Chong Tsai, MD, PhD

    National Yang Ming Chiao Tung University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 10, 2024

Study Start

October 6, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)