High MyopiaPhase 4NCT07406399
Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia
A Phase 4 study testing soft peripheral defocus contact lenses, Atropine 0.04% and Atropine (0.01%) in people with High Myopia and Low Concentration Atropine, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Peripheral contact lens in controlling myopia progression in high myopia children（PAM）is a prospective, single-center, randomized controlled trial with three parallel arms conducted at Beijing Tongren Hospital. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- High Myopia, Low Concentration Atropine, Soft Contact Lens
- What is being tested?
- soft peripheral defocus contact lenses, Atropine 0.04% and Atropine (0.01%)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2023to 30 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mainland Chinese children aged 4-16 years at enrollment
- Spherical equivalent refraction ≤-6.0D in both eyes under cycloplegia
- Astigmatism ≤2.5D in both eyes
- Anisometropia ≤2.5D
- Best corrected visual acuity ≥0.1 logMAR in both eyes
- Subject-reported non-significant ocular and systemic medical history
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- Ability and willingness to wear contact lenses (for intervention groups)
- Written informed consent from parents/guardians and assent from child
- Ability to attend all scheduled follow-up visits
Who cannot join
- Previous use of myopia control treatments (atropine, orthokeratology, multifocal lenses) within 3 months
- Current use of systemic medications affecting pupil size or accommodation
- Known allergies to atropine or contact lens materials
- Current use of systemic medications that may significantly affect contact lens wear, tear film production, pupil size, adaptability, or refractive status.
- Ocular diseases: strabismus, amblyopia, glaucoma, cataract, corneal disease
- Systemic diseases affecting ocular health
Show all 9Show fewer
- History of ocular surgery or trauma
- Inability to perform study procedures
- Participation in other clinical trials within 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study of Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia
Peripheral contact lens in controlling myopia progression in high myopia children（PAM）is a prospective, single-center, randomized controlled trial with three parallel arms conducted at Beijing Tongren Hospital. Chinese children aged 6-12 years with high myopia (spherical equivalent ≤-6.0D) and annual progression ≥0.75D will be enrolled. Participants will be randomized 40:40:40 to: (1) combination therapy group receiving atropine 0.04% plus soft peripheral defocus contact lenses; (2) atropine monotherapy group receiving atropine 0.04% plus spectacles; or (3) control group receiving atropine 0.01% plus spectacles. The primary outcome is change in axial length and cycloplegic refraction at 24 months. Secondary outcomes include changes in pupil diameter, and safety parameters.
- Conditions
- High Myopia, Low Concentration Atropine, Soft Contact Lens, Children
- Being tested
- soft peripheral defocus contact lenses, Atropine 0.04%, Atropine (0.01%), Single Vision Spectacles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft peripheral defocus contact lensesDevice
Multifocal soft contact lenses with peripheral defocus design have shown promise in reducing axial elongation. They work by reducing peripheral hyperopic defocus, which is thought to drive eye growth
Atropine 0.04%Drug
Low-concentration atropine eyedrops (atropine 0.04% and atropine 0.01% used in this trial) are the only consistently effective pharmacological treatment for myopia control
Atropine (0.01%)Drug
Low-concentration atropine eyedrops (atropine 0.04% and atropine 0.01% used in this trial) are the only consistently effective pharmacological treatment for myopia control
Single Vision SpectaclesDevice
Single Vision Spectacles are the most commonly used device in high myopia children, which demonstrate better pediatric compliance, eliminate infection risks, and involve lower long-term costs.
| Study group | Role | What they receive |
|---|---|---|
| combination therapy group | Experimental | 40 patients in combination therapy group received atropine 0.04% plus soft peripheral defocus contact lenses Receives: Device: soft peripheral defocus contact lenses; Drug: Atropine 0.04% |
| atropine monotherapy group | Experimental | 40 patients in atropine monotherapy group received atropine 0.04% plus spectacles Receives: Drug: Atropine 0.04%; Device: Single Vision Spectacles |
| control group | Placebo comparator | 40 patients in control group received atropine 0.01% plus spectacles Receives: Drug: Atropine (0.01%); Device: Single Vision Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length elongation
Axial length will be measured using the IOLMaster 500 optical biometry system (Carl Zeiss Meditec, Jena, Germany). To ensure measurement reliability and minimize random error, five consecutive measurements will be obtained for each eye at each visit, with individual measurements required to have a signal-to-noise ratio ≥2.0. The mean value of these five measurements will be calculated and used for analysis. Measurements will be standardized by time of day, conducted between 1:00 PM and 5:00 PM at all visits to minimize the influence of diurnal variations in axial length.
Measured: from baseline to 24 months
Secondary outcomes (1)
Change in cycloplegic spherical equivalent refraction
The change in spherical equivalent refraction (SE = sphere + cylinder/2) under cycloplegia, measured from baseline. Cycloplegia will be induced using compound tropicamide eyedrops per a standardized protocol and confirmed by pupil diameter (≥6 mm) and light reflex assessment. Refraction will then be measured using an autorefractor (Topcon KR-8800). Five measurements will be taken per eye, and the mean SE will be calculated from readings with a divergence of less than 0.25 D.
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start30 Jun 2023
- Primary completion30 Nov 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mengtian Kang, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406399
- Sponsor's protocol ID
- TREC2022-KY110
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia
- ClinicalTrials.gov ID
- NCT07406399
- Acronym / sponsor ID
- TREC2022-KY110
- Conditions
- High Myopia, Low Concentration Atropine, Soft Contact Lens, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripheral contact lens in controlling myopia progression in high myopia children（PAM）is a prospective, single-center, randomized controlled trial with three parallel arms conducted at Beijing Tongren Hospital. Chinese children aged 6-12 years with high myopia (spherical equivalent ≤-6.0D) and annual progression ≥0.75D will be enrolled. Participants will be randomized 40:40:40 to: (1) combination therapy group receiving atropine 0.04% plus soft peripheral defocus contact lenses; (2) atropine monotherapy group receiving atropine 0.04% plus spectacles; or (3) control group receiving atropine 0.01% plus spectacles. The primary outcome is change in axial length and cycloplegic refraction at 24 months. Secondary outcomes include changes in pupil diameter, and safety parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| combination therapy group | Experimental | Device: soft peripheral defocus contact lenses, Drug: Atropine 0.04%40 patients in combination therapy group received atropine 0.04% plus soft peripheral defocus contact lenses |
| atropine monotherapy group | Experimental | Drug: Atropine 0.04%, Device: Single Vision Spectacles40 patients in atropine monotherapy group received atropine 0.04% plus spectacles |
| control group | Placebo comparator | Drug: Atropine (0.01%), Device: Single Vision Spectacles40 patients in control group received atropine 0.01% plus spectacles |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Mainland Chinese children aged 4-16 years at enrollment
- Spherical equivalent refraction ≤-6.0D in both eyes under cycloplegia
- Astigmatism ≤2.5D in both eyes
- Anisometropia ≤2.5D
- Best corrected visual acuity ≥0.1 logMAR in both eyes
Key exclusion criteria (9 listed)
- Previous use of myopia control treatments (atropine, orthokeratology, multifocal lenses) within 3 months
- Current use of systemic medications affecting pupil size or accommodation
- Known allergies to atropine or contact lens materials
- Current use of systemic medications that may significantly affect contact lens wear, tear film production, pupil size, adaptability, or refractive status.
- Ocular diseases: strabismus, amblyopia, glaucoma, cataract, corneal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| soft peripheral defocus contact lensesMultifocal soft contact lenses with peripheral defocus design have shown promise in reducing axial elongation. They work by reducing peripheral hyperopic defocus, which is thought to drive eye growth | Device | combination therapy group |
| Atropine 0.04%Low-concentration atropine eyedrops (atropine 0.04% and atropine 0.01% used in this trial) are the only consistently effective pharmacological treatment for myopia control | Drug | atropine monotherapy group, combination therapy group |
| Atropine (0.01%)Low-concentration atropine eyedrops (atropine 0.04% and atropine 0.01% used in this trial) are the only consistently effective pharmacological treatment for myopia control | Drug | control group |
| Single Vision SpectaclesSingle Vision Spectacles are the most commonly used device in high myopia children, which demonstrate better pediatric compliance, eliminate infection risks, and involve lower long-term costs. | Device | atropine monotherapy group, control group |
Primary outcome
Axial length elongation
Time frame: from baseline to 24 months
Axial length will be measured using the IOLMaster 500 optical biometry system (Carl Zeiss Meditec, Jena, Germany). To ensure measurement reliability and minimize random error, five consecutive measurements will be obtained for each eye at each visit, with individual measurements required to have a signal-to-noise ratio ≥2.0. The mean value of these five measurements will be calculated and used for analysis. Measurements will be standardized by time of day, conducted between 1:00 PM and 5:00 PM at all visits to minimize the influence of diurnal variations in axial length.
1 secondary outcome
Change in cycloplegic spherical equivalent refraction
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing soft peripheral defocus contact lenses, Atropine 0.04% and Atropine (0.01%) in people with High Myopia and Low Concentration Atropine, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length elongation (time frame: from baseline to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.