Clinical Trial

Myopia Prevention in Young Premyopic Children Using Defocus Incorporated Multiple Segments Spectacle Lenses

Not Yet Recruiting
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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 Triple Enhanced Design (AI-DIMS) spectacle lenses 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 Limited
Conditions Pre-myopia, Myopia
Enrollment 128 participants
Start Date 2026-09-12
Primary Completion 2028-05-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-14