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RecruitingNCT06523504atropineUpdated Sep 8, 2025

Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control

A Phase 1/2 interventional study of DIMS and The 0.02% ATP Group in Myopia, sponsored by Ruihua Wei. Recruiting at 1 site in China. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Ruihua Wei · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the detailed description

In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.

02

Conditions studied

  • Myopia

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03

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • Note: if both eyes meet the inclusion criteria, the eye with higher spherical equivalent is the study eye; if one eye meets the inclusion criteria, the eye is the study eye.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Other reasons researchers think it is not suitable for inclusion in researchers
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
410 participants (estimated)

Study arms

  • Experimental
    The DIMS Group

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

    Device: DIMS

  • Experimental
    0.02% ATP

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

    Drug: The 0.02% ATP Group

  • Experimental
    0.04%ATP

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

    Drug: The 0.04% ATP Group

  • Experimental
    0.02%ATP+DIMS

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

    Combination Product: 0.02%ATP+DIMS

  • Experimental
    0.04%ATP+DIMS

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

    Combination Product: 0.04%ATP+DIMS

Interventions

  • DeviceDIMS

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

  • DrugThe 0.02% ATP Group

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

  • DrugThe 0.04% ATP Group

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

  • Combination product0.02%ATP+DIMS

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

  • Combination product0.04%ATP+DIMS

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

05

What researchers measure

Primary outcomes

  1. Best Corrected Visual Acuity

    Best Corrected Visual Acuity

    Time frame: up to 24 months

06

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University Eye Hospital
    Tianjin, Tianjin Municipality 120120, China
    • Meinan He · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06523504
Lead sponsor
Ruihua Wei
Collaborators
Beijing Tongren Hospital
Responsible party
Ruihua Wei (Professor, Tianjin Medical University Eye Hospital) — Sponsor-investigator
First posted
Jul 26, 2024
Start date
Feb 1, 2024
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Sep 8, 2025

Study contacts

Meinan He
Contact
hmn509@tmu.edu.cn
+8613672135765

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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