Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial

NCT07765550 — Not applicable, Not yet recruiting, 128 participants, Shanghai Eye Disease Prevention and Treatment Center

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Registry	NCT07765550
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	128 (Estimated)
Sponsor	Shanghai Eye Disease Prevention and Treatment Center (Other); collaborators: HOYA Lens Thailand LTD.
Conditions	Pre-myopia, Myopia
Interventions	Artificial Intelligence Assisted DIMS based Spectacle Lens, Smartwatches (Device)
Dates	start 2026-09-12 (estimated), primary completion 2028-05-31 (estimated), completion 2028-08-31 (estimated), first posted 2026-08-14, last updated 2026-08-18
Locations	1 site in China

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention group	Experimental	Device: Artificial Intelligence Assisted DIMS based Spectacle Lens; Device: Smartwatches	Wear AI-assisted DIMS-based spectacle lens (at least 10 hours a day), as well as smartwatches
Control group	Other	Device: Smartwatches	Wear smartwatches

Artificial Intelligence Assisted DIMS based Spectacle Lens (Device): 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.
Smartwatches (Device): 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.

+Outcome measures

Primary outcomes

Changes in axial length [From baseline to the 12-month follow-up]

Secondary outcomes

Changes in Cycloplegic Spherical Equivalent Refraction (SER) [From baseline to the 12-month follow-up]
Changes in Choroidal Thickness (CT) [From baseline to the 12-month follow-up]
Spectacle-wearing compliance and spectacle-wearing time [From baseline to the 12-month follow-up]

Other outcomes

Changes in Pupil Diameter [From baseline to the 12-month follow-up]
Changes in Intraocular Pressure (IOP) [From baseline to the 12-month follow-up]
Changes in Best Corrected Visual Acuity [From baseline to the 12-month follow-up]
Adverse event profile [At 12-month follow-up]

+Eligibility

Sex: All, ages: 3 Years to 6 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
Shanghai Eye Disease Prevention and Treatment Center	Shanghai, Shanghai Municipality	China

+Investigators

He, Prof, Principal investigator, Shanghai Eye Disease Prevention and Treatment Center