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

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Interventions: Artificial Intelligence-Assisted Defocus Incorporated Multiple Segment Triple Enhanced Design (AI-DIMS TED) Spectacle Lenses (Device)… to Artificial Intelligence Assisted DIMS based Spectacle Lens (Device), Smartwatches (Device)
    • Collaborator revised
    • Study title expanded, about 8 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07765550
Lead Sponsor Shanghai Eye Disease Prevention and Treatment Center
Collaborators: HOYA Lens Thailand LTD.
Conditions
(from sponsor)		 Pre-myopia, Myopia
Related terms Myopia
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov