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

Recruiting now · Not applicable

Conditions studied: Children With Myopia, Treatment, Multizone Lens Design for Myopic Defocus, Visual Quality, Efficacy

In brief

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.

Key facts

Study ID

NCT07323251

Run by

Beijing Tongren Hospital

People needed

120

Starts

2024-08-02

Expected to finish

2026-09-30

Last updated by the study team

2026-01-07

Who can join

Age: 6 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 6-14 years
• Myopic spherical equivalent refraction between -0.75D and -4.00D (inclusive of -0.75D and -4.00D, based on cycloplegic refraction)
• Astigmatism ≤1.50D
• Anisometropia ≤1.50D
• Best-corrected visual acuity (BCVA) reaching 5.0 (0.00 LogMAR) or better in both eyes; monocular BCVA reaching 5.0 (0.00 LogMAR) or better after wearing myopic defocus spectacles
• Absence of organic ocular diseases
• No history of myopia control treatment within the past three months, including orthokeratology, progressive multifocal lenses, peripheral defocus spectacle lenses, bifocal spectacle lenses, defocus-designed soft hydrophilic contact lenses, other myopia control medications, or light-therapy devices
• Voluntary participation in this clinical study and provision of signed informed consent

You may not qualify if…

• History of ocular trauma or surgery
• Systemic diseases affecting visual function
• Inability to cooperate with examinations
• Poor compliance
• Inability to adhere to wearing requirements and follow-up visits during the trial period

Where it is running

• Beijing Tongren Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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