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New study tests extra treatments for kids whose nearsightedness keeps getting worse despite special lenses

NCT ID NCT07494799

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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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 Results may not be published yet.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

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Status unknown
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First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study will enroll about 3,890 children aged 8-12 who still have rapidly worsening nearsightedness (myopia) even after using orthokeratology (Ortho-K) lenses. Researchers will compare four approaches: continuing Ortho-K alone, adding low-dose atropine eye drops, using lenses with a smaller optical zone, or adding low-intensity red light therapy. The goal is to see which strategy best slows the lengthening of the eye over one year.

What this could mean

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

Active substance
0.01% atropine sulfate eye drops; low-intensity red light therapy
What this could lead to
If successful, this could identify the best way to slow worsening nearsightedness in children who still progress despite wearing orthokeratology lenses.
What could go wrong
This is a prospective study that hasn't started recruiting yet. Results may not apply to all children, and some interventions (like atropine drops or red light) may cause side effects such as eye irritation or discomfort.

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.

Participants

About 3,890 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 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.

Who is studied

Children aged 8-12 years with myopia who have worn orthokeratology (OK) lenses for at least 1 year, with axial length elongation \>0.3mm in the past 12 months, indicating progressive myopia despite OK lens wear. Both male and female participants are eligible, with no gender restriction.

Ages

8 to 12 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\) The initial fitting age is between 8-12 years, irrespective of gender; 2) The spherical equivalent refraction (SE) of both eyes at the initial fitting falls within the manufacturer's approved range of -6.00D to -0.50D; 3) The best corrected visual acuity of both eyes is ≥1.0 (Snellen); 4) The ability to ensure overnight Ortho-K lens wear for a duration of 8 to 10 hours; 5) No prior history of ocular trauma or surgery; 6) No prior history of acute or chronic ocular inflammation, such as keratoconjunctivitis or abnormal tear film; 7) The ability to meticulously adhere to instructions for lens care and attend regular follow-up examinations; 8) The standard use of other myopia progression interventions, such as 0.01% atropine or red-light therapy as prescribed; 9) Comprehensive follow-up data; 10) At least one eye exhibits an annual axial length elongation of \>0.30 mm during the first year of Ortho-K lens wear. Exclusion Criteria: 1\) Axial length elongation less than 0.30 mm in both eyes during the first year of Ortho-K treatment; 2) Incidence of significant complications during the study period, such as recurrent corneal inflammation; 3) Incomplete data or cases lost to follow-up; 4) SE of either eye less than -6.00D, or astigmatism greater than -2.00D; 5) Unstable vision during Ortho-K treatment, characterized by multiple instances of vision below 0.2 (LogMAR); 6) Change in the brand of Ortho-K lens. This study utilized a retrospective data collection approach. To prevent the influence of non-independent data from both eyes of a single participant on statistical analyses, data from only one eye per subject were included in the final analysis. The selection criterion prioritized data from the right eye; however, if the right eye did not satisfy the primary inclusion criterion of "annual axial elongation \>0.30 mm," data from the left eye were used instead. This study was conducted in accordance with the Declaration of Helsinki and received approval from the Ethics Committee of the Tianjin Medical University Eye Hospital. Informed consent was obtained from the guardians of all participating children.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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