New study tests extra treatments for kids whose nearsightedness keeps getting worse despite special lenses
NCT ID NCT07494799
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Orthokeratology-related myopia progression are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.