AI-assisted DIMS glasses to stop myopia in young children with pre-myopia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a parallel-design, open-label, randomized controlled trial conducted at a single center in Shanghai. Children aged 3–6 with low hyperopic reserve will be assigned to receive AI-assisted defocus-incorporated multi-segment spectacle lenses or control treatment, to see if myopia progression can be slowed or prevented. The study uses AI-powered optimization of lens defocus in the DIMS framework and includes safety monitoring and standard refractive outcomes. A secondary component includes smartwatches to support adherence and monitoring of visual behaviors.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Eye Disease Prevention and Treatment Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: He, Prof — Shanghai Eye Disease Prevention and Treatment Center
• Study coordinator: Xiangui He, Prof
• Email: xianhezi@163.com
• Phone: +86 15000755422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.