NCT06523504

Brief Summary

To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
410

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

February 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

2.2 years

First QC Date

July 19, 2024

Last Update Submit

August 30, 2025

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Visual Acuity

    Best Corrected Visual Acuity

    up to 24 months

Study Arms (5)

The DIMS Group

EXPERIMENTAL

wear DIMS ,and use placebo,once nightly, both eye

Device: DIMS

0.02% ATP

EXPERIMENTAL

wear SP, and use 0.02%ATP eye drops, once nightly, both eye

Drug: The 0.02% ATP Group

0.04%ATP

EXPERIMENTAL

wear SP, and use 0.04%ATP eye drops, once nightly, both eye

Drug: The 0.04% ATP Group

0.02%ATP+DIMS

EXPERIMENTAL

wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye

Combination Product: 0.02%ATP+DIMS

0.04%ATP+DIMS

EXPERIMENTAL

wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye

Combination Product: 0.04%ATP+DIMS

Interventions

DIMSDEVICE

wear DIMS ,and use placebo,once nightly, both eye

The DIMS Group
The 0.02% ATP GroupDRUG

wear SP, and use 0.02%ATP eye drops, once nightly, both eye

0.02% ATP
The 0.04% ATP GroupDRUG

wear SP, and use 0.04%ATP eye drops, once nightly, both eye

0.04%ATP
0.02%ATP+DIMSCOMBINATION_PRODUCT

wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye

0.02%ATP+DIMS
0.04%ATP+DIMSCOMBINATION_PRODUCT

wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye

0.04%ATP+DIMS

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • School-age children aged 6 to 12 years (including boundary value)
  • Children with moderate or high myopia (subjective refraction after cycloplegia: -9.00D≤spherical equivalent (SE)≤-3.00D, with-rule astigmatism (C)≤2.00D, against-rule astigmatism (C)≤1.00D, anisometropia of both eyes≤2.50D)
  • Binocular best corrected visual acuity (BCVA)≥0.8 (five-point visual acuity 4.9)
  • Agree with the study scheme and sign the informed consent

You may not qualify if:

  • Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in the past month; used red light treatment in the past
  • Children with obvious strabismus and amblyopia
  • With congenital eye disease, such as congenital cataract, congenital retinal disease
  • Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
  • Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
  • Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
  • Bnormal intraocular pressure and clinical significance (IOP \<10 mmHg or IOP \>21mmHg or binocular IOP difference ≥5mmHg)
  • Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
  • Optic nerve damage or congenital optic nerve dysfunction
  • Can not be regularly checked
  • The adjustment range is less than 8D or obvious near difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 120120, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Meinan He

CONTACT

+8613672135765hmn509@tmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 26, 2024

Study Start

February 1, 2024

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)