MyopiaPhase 1/2atropineNCT06523504
Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
A Phase 1/2 study testing DIMS, The 0.02% ATP Group and The 0.04% ATP Group in people with Myopia, run by Ruihua Wei at 1 site in China.
Trial summary
To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- DIMS, The 0.02% ATP Group and The 0.04% ATP Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- School-age children aged 6 to 12 years (including boundary value)
- Children with moderate or high myopia (subjective refraction after cycloplegia: -9.00D≤spherical equivalent (SE)≤-3.00D, with-rule astigmatism (C)≤2.00D, against-rule astigmatism (C)≤1.00D, anisometropia of both eyes≤2.50D)
- Binocular best corrected visual acuity (BCVA)≥0.8 (five-point visual acuity 4.9)
- Agree with the study scheme and sign the informed consent
- Note: if both eyes meet the inclusion criteria, the eye with higher spherical equivalent is the study eye; if one eye meets the inclusion criteria, the eye is the study eye.
Who cannot join
- Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in the past month; used red light treatment in the past
- Children with obvious strabismus and amblyopia
- With congenital eye disease, such as congenital cataract, congenital retinal disease
- Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
- Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
- Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
Show all 12Show fewer
- Bnormal intraocular pressure and clinical significance (IOP \<10 mmHg or IOP \>21mmHg or binocular IOP difference ≥5mmHg)
- Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
- Optic nerve damage or congenital optic nerve dysfunction
- Can not be regularly checked
- The adjustment range is less than 8D or obvious near difficulties
- Other reasons researchers think it is not suitable for inclusion in researchers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 120120
Meinan He
About this study
Official title: Efficacy and Safety of Low-concentration Atropine Eye Drops (0.02%, 0.04%) Combined With Defocus Incorporated Multiple Segments (DIMS) for Moderate and High Myopia Control
To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.
Read the detailed description
In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.
- Conditions
- Myopia
- Being tested
- DIMS, The 0.02% ATP Group, The 0.04% ATP Group, 0.02%ATP+DIMS, 0.04%ATP+DIMS
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIMSDevice
wear DIMS ,and use placebo,once nightly, both eye
The 0.02% ATP GroupDrug
wear SP, and use 0.02%ATP eye drops, once nightly, both eye
The 0.04% ATP GroupDrug
wear SP, and use 0.04%ATP eye drops, once nightly, both eye
0.02%ATP+DIMSCombination product
wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye
0.04%ATP+DIMSCombination product
wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye
| Study group | Role | What they receive |
|---|---|---|
| The DIMS Group | Experimental | wear DIMS ,and use placebo,once nightly, both eye Receives: Device: DIMS |
| 0.02% ATP | Experimental | wear SP, and use 0.02%ATP eye drops, once nightly, both eye Receives: Drug: The 0.02% ATP Group |
| 0.04%ATP | Experimental | wear SP, and use 0.04%ATP eye drops, once nightly, both eye Receives: Drug: The 0.04% ATP Group |
| 0.02%ATP+DIMS | Experimental | wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye Receives: Combination Product: 0.02%ATP+DIMS |
| 0.04%ATP+DIMS | Experimental | wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye Receives: Combination Product: 0.04%ATP+DIMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Best Corrected Visual Acuity
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Feb 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruihua Wei
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Responsible party
- Sponsor-investigator, Ruihua Wei, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523504
- Sponsor's protocol ID
- 2019yj001J-5
- Other IDs
- 2019yj001J-5
- Acronym
- atropine
- Status last verified
- Aug 2025
- First submitted
- 19 Jul 2024
- Last updated
- 8 Sep 2025
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-concentration Atropine Eye Drops (0.02%, 0.04%) Combined With Defocus Incorporated Multiple Segments (DIMS) for Moderate and High Myopia Control
- ClinicalTrials.gov ID
- NCT06523504
- Acronym / sponsor ID
- atropine / 2019yj001J-5
- Conditions
- Myopia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Ruihua WeiUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 26 Jul 2024 (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.
To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.
Detailed description
In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| The DIMS Group | Experimental | Device: DIMSwear DIMS ,and use placebo,once nightly, both eye |
| 0.02% ATP | Experimental | Drug: The 0.02% ATP Groupwear SP, and use 0.02%ATP eye drops, once nightly, both eye |
| 0.04%ATP | Experimental | Drug: The 0.04% ATP Groupwear SP, and use 0.04%ATP eye drops, once nightly, both eye |
| 0.02%ATP+DIMS | Experimental | Combination Product: 0.02%ATP+DIMSwear DIMS, and use 0.02%ATP eye drops, once nightly, both eye |
| 0.04%ATP+DIMS | Experimental | Combination Product: 0.04%ATP+DIMSwear DIMS, and use 0.04%ATP eye drops, once nightly, both eye |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- School-age children aged 6 to 12 years (including boundary value)
- Children with moderate or high myopia (subjective refraction after cycloplegia: -9.00D≤spherical equivalent (SE)≤-3.00D, with-rule astigmatism (C)≤2.00D, against-rule astigmatism (C)≤1.00D, anisometropia of both eyes≤2.50D)
- Binocular best corrected visual acuity (BCVA)≥0.8 (five-point visual acuity 4.9)
- Agree with the study scheme and sign the informed consent
- Note: if both eyes meet the inclusion criteria, the eye with higher spherical equivalent is the study eye; if one eye meets the inclusion criteria, the eye is the study eye.
Key exclusion criteria (12 listed)
- Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in the past month; used red light treatment in the past
- Children with obvious strabismus and amblyopia
- With congenital eye disease, such as congenital cataract, congenital retinal disease
- Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
- Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
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 |
|---|---|---|
| DIMSwear DIMS ,and use placebo,once nightly, both eye | Device | The DIMS Group |
| The 0.02% ATP Groupwear SP, and use 0.02%ATP eye drops, once nightly, both eye | Drug | 0.02% ATP |
| The 0.04% ATP Groupwear SP, and use 0.04%ATP eye drops, once nightly, both eye | Drug | 0.04%ATP |
| 0.02%ATP+DIMSwear DIMS, and use 0.02%ATP eye drops, once nightly, both eye | Combination product | 0.02%ATP+DIMS |
| 0.04%ATP+DIMSwear DIMS, and use 0.04%ATP eye drops, once nightly, both eye | Combination product | 0.04%ATP+DIMS |
Primary outcome
Best Corrected Visual Acuity
Time frame: up to 24 months
Best Corrected Visual Acuity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DIMS, The 0.02% ATP Group and The 0.04% ATP Group in people with Myopia, run by Ruihua Wei 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meinan He (+8613672135765, hmn509@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: up 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 8 Sep 2025.