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New glasses design may help stop Kids' eyesight from getting worse

NCT ID NCT05894382

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests whether special glasses with a double helix lens design can slow the progression of myopia (nearsightedness) in children and adolescents aged 6 to 13. About 236 participants will wear either the new glasses or standard single-vision glasses for over 10 hours a day. Researchers will measure changes in eye prescription and eye length over time to see if the new design is safe and effective.

What this could mean

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

Active substance
Double helix design defocus lens spectacle frames
What this could lead to
If successful, these glasses could offer a simple, non-invasive way to slow down worsening nearsightedness in children, reducing the need for stronger prescriptions.
What could go wrong
This is an early-stage study with 236 participants, so results may not apply to all children. The glasses must be worn over 10 hours daily, which may be challenging, and long-term safety is still being evaluated.

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 236 people

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

Started

Jun 2023

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

6 to 13 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. Race: Chinese children and adolescents. 2. Age 6-13 years, gender unrestricted. 3. Cycloplegic refraction SER: -0.75DS\~-5.0DS in both eyes. 4. Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6). 5. Refractive astigmatism and astigmatism are no more than 1.5D. 6. During the study period, willing to wear glasses provided by the researcher only (\>10 hours) and without additional interventions. 7. Willing to be randomly assigned. 8. Able to sign an informed consent form with the accompaniment and understanding of parents or guardians. Exclusion Criteria: 1. Allergic or intolerant to medications used for ciliary muscle paralysis. 2. Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within 30 days before the study. 3. Received defocus lenses for nearsightedness treatment in the past. 4. Diagnosed with any eye disease other than nearsightedness, including strabismus (esotropia greater than 8 prism diopters or exotropia greater than 12 prism diopters), corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.). 5. History of eye surgery (including strabismus correction surgery). 6. Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc. 7. Anatomical or dermatological factors that may interfere with the wearing of spectacle frames. 8. Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.

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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

  • Xiangui He

    Shanghai, Shanghai Municipality, 201103, China

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