Clinical Trial

Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression

Recruiting
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Summary
Clinical Trial The goal of this clinical trial is to evaluate the effectiveness of two types of Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in slowing myopia progression in children. It will also assess the safety of these lenses. The main questions it aims to answer are: Do D.S.D.O. lenses reduce the progression of myopia as measured by changes in cycloplegic refraction and axial length? What adverse events do participants experience when wearing D.S.D.O. lenses? Researchers will compare two optical designs of D.S.D.O. lenses (Intervention Group1: Design 1; Intervention Group2: Design 2) to determine their relative efficacy in controlling myopia progression. Participants will: Wear assigned D.S.D.O. lenses daily for 12 months (except during sleep or unavoidable situations). Attend clinic visits at baseline, 3, 6, 9, and 12 months for comprehensive eye examinations. Maintain a diary recording daily wear time, visual symptoms, and any adverse events.
Trial Details
NCT Number NCT07323251
Lead Sponsor Beijing Tongren Hospital
Conditions Children With Myopia, Treatment, Multizone Lens Design for Myopic Defocus, Visual Quality, Efficacy
Enrollment 120 participants
Start Date 2024-08-02
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-07