Pre-myopiaNCT07765550
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
A study testing Artificial Intelligence Assisted DIMS based Spectacle Lens and Smartwatches in people with Pre-myopia and Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Pre-myopia, Myopia
- What is being tested?
- Artificial Intelligence Assisted DIMS based Spectacle Lens and Smartwatches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2026to 31 Aug 2028
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 3 and 6 years (inclusive), regardless of gender or ethnicity.
- Cycloplegic spherical equivalent refraction (SER) of the worse eye > -0.50 D and ≤ +0.75 D, absolute cylindrical power ≤ 1.0 D, anisometropia ≤ 1.5 D.
- Best corrected monocular distance high contrast VA ≥ 0.5 for ages 3-5; ≥ 0.7 for age 6.
- At least one parent with SER ≤-3.00D
Who cannot join
- Individuals with any ocular or systemic diseases that may affect vision and refractive development (e.g., keratoconus, abnormalities in lens shape or position, Marfan syndrome, retinopathy of prematurity, etc.).
- Individuals with known allergies or contraindications to cycloplegic agents.
- Previous use of myopia management treatment (spectacles, atropine; CLs).
- Individuals with binocular vision abnormalities: manifest strabismus, monocular suppression, abnormal fusion function, or impaired stereopsis.
- Individuals unable to cooperate with examinations or communicate.
- Any other conditions deemed by the investigator as unsuitable for participation in the study.
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
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality
Tianyu Cheng, Dr, +86 18817552005, s70444@126.com
About this study
Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high. Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted defocus incorporated multiple segments (DIMS) based spectacle lens in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.
- Conditions
- Pre-myopia, Myopia
- Being tested
- Artificial Intelligence Assisted DIMS based Spectacle Lens, Smartwatches
- Keywords
- pre-myopia, young children, AI-assisted DIMS-based spectacle lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence Assisted DIMS based Spectacle LensDevice
The AI-DIMS defocus spectacle frame, featuring DIMS-based lenses and an intelligent AI frame, is designed to be worn for at least 10 hours per day. The frame automatically tracks and records wearing duration parameters.
SmartwatchesDevice
Inserted prompt system of the smartwatches can remind the users to go outside. Inserted sensors can record outdoor parameters such as outdoor time, light intensity, activity pattern, etc.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Wear AI-assisted DIMS-based spectacle lens (at least 10 hours a day), as well as smartwatches Receives: Device: Artificial Intelligence Assisted DIMS based Spectacle Lens; Device: Smartwatches |
| Control group | Other | Wear smartwatches Receives: Device: Smartwatches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in axial length
Measured: From baseline to the 12-month follow-up
Secondary outcomes (3)
Changes in Cycloplegic Spherical Equivalent Refraction (SER)
Measured: From baseline to the 12-month follow-up
Changes in Choroidal Thickness (CT)
Measured: From baseline to the 12-month follow-up
Spectacle-wearing compliance and spectacle-wearing time
Measured: From baseline to the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start12 Sep 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- HOYA Lens Thailand LTD.
- Responsible party
- Sponsor
- Investigators
- He, Prof, Principal investigator, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765550
- Sponsor's protocol ID
- IIT2026-003-AMD-01
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07765550
- Acronym / sponsor ID
- IIT2026-003-AMD-01
- Conditions
- Pre-myopia, Myopia
- Keywords
- pre-myopia, young children, AI-assisted DIMS-based spectacle lens
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- HOYA Lens Thailand LTD.
- Study start
- 12 Sep 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 14 Aug 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.
Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high. Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted defocus incorporated multiple segments (DIMS) based spectacle lens in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Artificial Intelligence Assisted DIMS based Spectacle Lens, Device: SmartwatchesWear AI-assisted DIMS-based spectacle lens (at least 10 hours a day), as well as smartwatches |
| Control group | Other | Device: SmartwatchesWear smartwatches |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 3 and 6 years (inclusive), regardless of gender or ethnicity.
- Cycloplegic spherical equivalent refraction (SER) of the worse eye > -0.50 D and ≤ +0.75 D, absolute cylindrical power ≤ 1.0 D, anisometropia ≤ 1.5 D.
- Best corrected monocular distance high contrast VA ≥ 0.5 for ages 3-5; ≥ 0.7 for age 6.
- At least one parent with SER ≤-3.00D
Key exclusion criteria (6 listed)
- Individuals with any ocular or systemic diseases that may affect vision and refractive development (e.g., keratoconus, abnormalities in lens shape or position, Marfan syndrome, retinopathy of prematurity, etc.).
- Individuals with known allergies or contraindications to cycloplegic agents.
- Previous use of myopia management treatment (spectacles, atropine; CLs).
- Individuals with binocular vision abnormalities: manifest strabismus, monocular suppression, abnormal fusion function, or impaired stereopsis.
- Individuals unable to cooperate with examinations or communicate.
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 |
|---|---|---|
| Artificial Intelligence Assisted DIMS based Spectacle LensThe AI-DIMS defocus spectacle frame, featuring DIMS-based lenses and an intelligent AI frame, is designed to be worn for at least 10 hours per day. The frame automatically tracks and records wearing duration parameters. | Device | Intervention group |
| SmartwatchesInserted prompt system of the smartwatches can remind the users to go outside. Inserted sensors can record outdoor parameters such as outdoor time, light intensity, activity pattern, etc. | Device | Control group, Intervention group |
Primary outcome
Changes in axial length
Time frame: From baseline to the 12-month follow-up
3 secondary outcomes
Changes in Cycloplegic Spherical Equivalent Refraction (SER)
Time frame: From baseline to the 12-month follow-up
Changes in Choroidal Thickness (CT)
Time frame: From baseline to the 12-month follow-up
Spectacle-wearing compliance and spectacle-wearing time
Time frame: From baseline to the 12-month follow-up
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 18 Aug 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.
He, Prof principal investigator
Shanghai Eye Disease Prevention and Treatment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence Assisted DIMS based Spectacle Lens and Smartwatches in people with Pre-myopia and Myopia, run by Shanghai Eye Disease Prevention and Treatment Center 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 Aug 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. 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 Xiangui He, Prof (+86 15000755422, xianhezi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in axial length (time frame: From baseline to the 12-month follow-up). 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 18 Aug 2026.