Combining atropine eye drops with defocus DIMS for controlling myopia in children

Efficacy and Safety of Low-concentration Atropine Eye Drops (0.02%, 0.04%) Combined With Defocus Incorporated Multiple Segments (DIMS) for Moderate and High Myopia Control

This study is testing if using atropine eye drops together with special glasses can help children aged 6 to 12 with moderate to high myopia see better and slow down their eye growth.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 410 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Tianjin Medical University Eye Hospital (Academic / other)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06523504 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of low concentration atropine eye drops combined with defocus DIMS in controlling axial length and refraction in children aged 6 to 12 with moderate to high myopia. A total of 410 participants will be randomly assigned to one of five treatment groups using stratified block randomization across multiple centers. The study aims to determine the best approach for managing myopia progression in this age group through a multicenter design.

Who should consider this trial

Good fit: Ideal candidates are school-age children aged 6 to 12 years with moderate to high myopia.

Not a fit: Patients currently using other myopia control methods or with certain eye conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for controlling myopia progression in children.

How similar studies have performed: Other studies have shown promise in using atropine for myopia control, but this specific combination approach is novel.

Eligibility criteria

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

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Eye Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Meinan He

Conditions Myopia