A new strategy to slow nearsightedness in kids: switching between two proven treatments

NCT ID NCT06667037

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether alternating two common myopia treatments—nightly ortho-k contact lenses and low-dose atropine eye drops—can slow the progression of nearsightedness in children and teens more effectively than using ortho-k lenses alone. The study will enroll 112 participants aged 8 to 15 with mild to moderate myopia and track changes in eye length over 25 months. If the sequential approach works, it could offer a new way to manage childhood myopia and reduce future vision risks.

What this could mean

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

Active substance
Orthokeratology (Ortho-k) lenses and 0.01% atropine eye drops
What this could lead to
If successful, this could offer a more effective way to slow nearsightedness in children, potentially reducing the risk of severe vision problems later in life.
What could go wrong
The trial is relatively small and early, and results may not apply to all children. Ortho-k lenses carry a small risk of eye infections, and atropine can cause light sensitivity or blurred 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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 112 people

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

Started

Sep 2024

Expected to finish

Dec 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

8 to 15 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: 1. Aged 8-15 years old. 2. Spherical equivalent refractions (SERs) -0.50 to -6.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D. 3. Best corrected visual acuity (BCVA) equal to or better than 20/25 in both eyes. 4. Bilateral intra-ocular pressure \< 21mmHg. 5. Normal binocular and stereoscopic visual function. 6. Participants and their guardians' understanding and acceptance of random allocation of grouping. Exclusion Criteria: 1. Manifest strabismus, except for intermittent tropia. 2. Ocular or systemic diseases which may affect vision or refractive error. 3. Previous use of myopia control without washout, including atropine, myopia control spectacles, myopia control contact lenses. 4. Other contraindications.

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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.

Contacts and locations

Locations

  • Zhongshan Ophthalmic Center Sun Yat-Sen University

    Guangzhou, Guangdong, 510060, China

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