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

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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