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New glasses lens could slow Kids' nearsightedness

NCT ID NCT06647160

Disease control Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special lens called Blue Star MAX-5 can slow the progression of nearsightedness (myopia) in children aged 8 to 11. Two hundred kids will wear either the new lens or standard glasses and be checked every six months for two years. The goal is to see if the new lens reduces changes in eye prescription and eye growth.

What this could mean

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

Active substance
Blue Star MAX-5 spectacle lens (a special lens with concentric columnar microstructures)
What this could lead to
If it works, this lens could help slow down worsening nearsightedness in children, reducing the need for stronger glasses over time.
What could go wrong
This is a relatively small trial (200 children) and results may not apply to all kids. The lens may not slow myopia better than standard glasses, and long-term effects are unknown.

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 200 people

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

Started

Nov 2024

Expected to finish

Mar 2027

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 11 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: * Aged 8 to 11 years; * Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -6.00 to -0.50 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D; * Best-corrected visual acuity of equal or better than 0.00 LogMAR (\>= 1.0 as Snellen). * The intraocular pressure of 10 to 21mmHg. * Volunteer to participate in this clinical trial with signature of the informed consent form. Exclusion Criteria: * History of eye injury or intraocular surgery; * Clinically abnormal slit-lamp findings * Abnormal fundus examination * Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function; * Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses); * Participation of the drug clinical trial within three month and the device clinical trial within one month; * Only one eye meets the inclusion criteria; * Unable to have regular follow-up * Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursingproducts), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.

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Conditions

The condition(s) this trial relates to.

degenerative myopia myopia

As listed by the trial registrant

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

Myopia, progressive

Contacts and locations

Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

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