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

Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Study ID
NCT07765550
Status
Not Yet Recruiting

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Conditions

  • Myopia
  • Pre-myopia

Eligibility Criteria

Sex
ALL
Age
3 Years - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Sep 12, 2026
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention group
    Wear AI-assisted DIMS-based spectacle lens (at least 10 hours a day), as well as smartwatches
  • Other: Control group
    Wear smartwatches

Primary Outcome Measure

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

Central Contacts

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