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Recruiting Phase 1/2

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

NCT06523504 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Phase 1/2
Started
2024-02-01
Last updated
2025-09-08

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

DIMSThe 0.02% ATP GroupThe 0.04% ATP Group0.02%ATP+DIMS0.04%ATP+DIMS

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

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

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

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

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

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
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: * 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

Primary outcome measure(s)

  • Best Corrected Visual Acuity — up to 24 months
    Best Corrected Visual Acuity

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Eye Hospital Tianjin Tianjin Municipality Recruiting
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 NCT06523504 on ClinicalTrials.gov ↗ ← All trials in China