An interventional study of Artificial Intelligence Assisted DIMS based Spectacle Lens and Smartwatches in Pre-myopia and Myopia, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Recruiting at 1 site in China. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Prevention
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 128 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 66 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Wear AI-assisted DIMS-based spectacle lens (at least 10 hours a day), as well as smartwatches
Device: Artificial Intelligence Assisted DIMS based Spectacle Lens · Device: Smartwatches
Wear smartwatches
Device: Smartwatches
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.
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.
Changes in axial length
Time frame: From baseline to the 12-month follow-up
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
Changes in Pupil Diameter
Time frame: From baseline to the 12-month follow-up
Changes in Intraocular Pressure (IOP)
Time frame: From baseline to the 12-month follow-up
Changes in Best Corrected Visual Acuity
Time frame: From baseline to the 12-month follow-up
Adverse event profile
Time frame: At 12-month follow-up
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Shanghai Eye Disease Prevention and Treatment Center