Can eye drops and special glasses stop Kids' nearsightedness from getting worse?
NCT ID NCT06523504
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether low-dose atropine eye drops (0.02% or 0.04%) combined with special glasses (DIMS) can slow the progression of moderate to high myopia (nearsightedness) in children aged 6 to 12. About 410 children will be assigned to different treatment groups and followed for changes in eye length and prescription. The goal is to find a safe, effective way to control myopia and reduce future eye health risks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- atropine eye drops (0.02% and 0.04%) and defocus incorporated multiple segments (DIMS) glasses
- What this could lead to
- If successful, this could offer a safe, non-surgical way to slow down worsening nearsightedness in children, reducing their risk of eye problems later in life.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with a moderate number of participants. The treatments may not work better than existing options, and atropine can cause side effects like light sensitivity or blurry near vision.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 410 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University Eye Hospital
RECRUITINGTianjin, Tianjin Municipality, 120120, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can AI protect Kids' eyesight where eye doctors are scarce?
- Two toric lenses go head to head in vision test
- Eye scans as a window to the body: study probes retinal imaging across diseases
- Lens showdown: which contact lens wins in dim light?
- Myopia glasses may keep working even after kids take them off
- Can glasses that slow nearsightedness also reshape a Child's astigmatism?