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New combo therapy may slow severe nearsightedness in kids

NCT ID NCT07406399

Disease control Sponsor: Beijing Tongren Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether combining low-dose atropine eye drops with special soft contact lenses can slow the progression of high myopia (severe nearsightedness) in children aged 6-12. 120 children were split into three groups: one got the combo therapy, one got atropine alone with glasses, and one got a lower dose of atropine with glasses. The main goal was to measure changes in eye length and prescription over 2 years.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

120 people

The number who actually took part.

Started

Jun 2023

Finished

Jan 2026

Lead sponsor

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

4 to 16 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Mainland Chinese children aged 4-16 years at enrollment * Spherical equivalent refraction ≤-6.0D in both eyes under cycloplegia * Astigmatism ≤2.5D in both eyes * Anisometropia ≤2.5D * Best corrected visual acuity ≥0.1 logMAR in both eyes * Subject-reported non-significant ocular and systemic medical history * Ability and willingness to wear contact lenses (for intervention groups) * Written informed consent from parents/guardians and assent from child * Ability to attend all scheduled follow-up visits Exclusion Criteria: * Previous use of myopia control treatments (atropine, orthokeratology, multifocal lenses) within 3 months * Current use of systemic medications affecting pupil size or accommodation * Known allergies to atropine or contact lens materials * Current use of systemic medications that may significantly affect contact lens wear, tear film production, pupil size, adaptability, or refractive status. * Ocular diseases: strabismus, amblyopia, glaucoma, cataract, corneal disease * Systemic diseases affecting ocular health * History of ocular surgery or trauma * Inability to perform study procedures * Participation in other clinical trials within 2 months

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Conditions

The condition(s) this trial relates to.

degenerative myopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Children High myopia Low concentration atropine Soft contact lens

Contacts and locations

Locations

  • Beijing Tongren Eye Center, Beijing Tongren Hospital

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.