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New combo treatment aims to stop Kids' nearsightedness from getting worse

NCT ID NCT06431841

Disease control Sponsor: Hospital San Carlos, Madrid Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether combining low-dose atropine eye drops with special glasses (DIMS lenses) can slow the worsening of nearsightedness in children better than atropine alone. About 111 kids aged 4–16 with progressing myopia will be randomly assigned to one of two groups. The main goal is to measure changes in eye prescription and eye length over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atropine 0.025% eye drops and DIMS spectacle lenses
What this could lead to
If successful, this could show that combining atropine drops with special defocus lenses slows nearsightedness in children better than atropine alone.
What could go wrong
This is a mid-stage trial with only 111 participants, so results may not apply to all children. Atropine can cause light sensitivity or blurry near vision, and the lenses may not be comfortable for everyone.

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

About 111 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Jun 2026

An estimate. End dates often move.

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 * Age between 4-16 years. * Signing of informed consent. * Refractive error: myopia greater than -1.00 diopters (D). * Myopia progression of at least -0.50 D in the last 12 months. * Astigmatism of 2 D or less and anisometropia of 1.50 D or less. * Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better. Exclusion criteria * Children under 4 years old and over 16 years old * Strabismus and binocular vision anomalies. * Alterations in eye fundus that the researcher consider necessary the patient exclution. * Ocular pathology of the anterior segment (media opacity such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision * Amblyopia * Previous eye surgery * Systemic pathology (cardiopulmonary pathology, connective tissue alterations, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination to be carried out (such as mental or psychomotor retardation) * Previous myopia control treatments including orthokeratology, rigid contact lenses, bifocal or myopia control soft contact lenses, bifocal and multifocal ophthalmic lenses within 3 months prior to the study.

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Conditions

The condition(s) this trial relates to.

myopia

As listed by the trial registrant

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

Myopia

Contacts and locations

Locations

  • Noemi Guemes

    Madrid, Madrid, 28040, Spain

More trials for these conditions

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