MyopiaNCT06821074
Defocus-Enhanced vs. Single Vision Spectacles in Myopia Control Visual Function Training
A study testing Defocus-enhanced spectacles and Single vision spectacles in people with Myopia, run by Beijing Visionly Plus Eye Hospital at 2 sites in China.
Trial summary
The purpose of this study is to compare the effectiveness of vision function training using defocus-enhanced spectacles (DIMS) versus single vision spectacles combined with vision function training in controlling myopia progression in children aged 6-18 years. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Myopia
- What is being tested?
- Defocus-enhanced spectacles and Single vision spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 8 Feb 2025to 28 Feb 2027
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 6-18 years.
- Diagnosed myopia with SER between -0.50D and -4.00D.
- Astigmatism ≤ 2.50DC.
- Anisometropia < 1.25D.
Who cannot join
- Suspected genetic syndromes (e.g., Stickler, Marfan).
- Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
- Myopia progression <0.50D SER in the last year.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing New Vision Eye Hospital
Beijing, 100020
Lin Yang, M.D., +86-17898805125, roc001cn@gmail.com
- Recruiting
Beijing Visionly Plus Eye Hospital
Beijing, 1000274
Lin Yang, M.D., +86-17898805125, roc001cn@gmail.com
About this study
Official title: Comparative Study of Visual Function Training With Defocus-Enhanced Spectacles vs. Single Vision Spectacles on Myopia Control in Children
The purpose of this study is to compare the effectiveness of vision function training using defocus-enhanced spectacles (DIMS) versus single vision spectacles combined with vision function training in controlling myopia progression in children aged 6-18 years.
- Conditions
- Myopia
- Being tested
- Defocus-enhanced spectacles, Single vision spectacles
- Keywords
- myopia, Visual Function Training, Defocus-Enhanced Spectacles, Single Vision Spectacles
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defocus-enhanced spectaclesDevice
Vision function training while wearing defocus-enhanced spectacles
Single vision spectaclesDevice
Vision function training while wearing single vision spectacles
| Study group | Role | What they receive |
|---|---|---|
| Defocus-enhanced spectacles | Experimental | Vision function training while wearing defocus-enhanced spectacles |
| Single vision spectacles | Placebo comparator | Vision function training while wearing single vision spectacles Receives: Device: Single vision spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spherical equivalent 12 months after the commencement of training.
Change in spherical equivalent 12 months after the commencement of training.
Measured: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.
Secondary outcomes (1)
Change in axial length 12 months after the commencement of training.
Change in axial length 12 months after the commencement of training.
Measured: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start8 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Visionly Plus Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- High Myopia Control Alliance (HIMALAYA), Beijing New Vision Eye Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821074
- Sponsor's protocol ID
- Himalaya202502
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Visual Function Training With Defocus-Enhanced Spectacles vs. Single Vision Spectacles on Myopia Control in Children
- ClinicalTrials.gov ID
- NCT06821074
- Acronym / sponsor ID
- Himalaya202502
- Conditions
- Myopia
- Keywords
- myopia, Visual Function Training, Defocus-Enhanced Spectacles, Single Vision Spectacles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Visionly Plus Eye HospitalUniversity, hospital or other
- Collaborators
- High Myopia Control Alliance (HIMALAYA), Beijing New Vision Eye Hospital
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 11 Feb 2025 (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.
The purpose of this study is to compare the effectiveness of vision function training using defocus-enhanced spectacles (DIMS) versus single vision spectacles combined with vision function training in controlling myopia progression in children aged 6-18 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Defocus-enhanced spectacles | Experimental | –Vision function training while wearing defocus-enhanced spectacles |
| Single vision spectacles | Placebo comparator | Device: Single vision spectaclesVision function training while wearing single vision spectacles |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 6-18 years.
- Diagnosed myopia with SER between -0.50D and -4.00D.
- Astigmatism ≤ 2.50DC.
- Anisometropia < 1.25D.
Key exclusion criteria (3 listed)
- Suspected genetic syndromes (e.g., Stickler, Marfan).
- Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
- Myopia progression <0.50D SER in the last year.
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 |
|---|---|---|
| Defocus-enhanced spectaclesVision function training while wearing defocus-enhanced spectacles | Device | – |
| Single vision spectaclesVision function training while wearing single vision spectacles | Device | Single vision spectacles |
Primary outcome
Change in spherical equivalent 12 months after the commencement of training.
Time frame: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.
Change in spherical equivalent 12 months after the commencement of training.
1 secondary outcome
Change in axial length 12 months after the commencement of training.
Time frame: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.
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 24 Apr 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication will be shared
Related trials for Myopia
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defocus-enhanced spectacles and Single vision spectacles in people with Myopia, run by Beijing Visionly Plus Eye Hospital at 2 sites 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 4 inclusion and 3 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Lin Yang, M.D. (+86-17898805125, roc001cn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spherical equivalent 12 months after the commencement of training. (time frame: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.). 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 24 Apr 2025.