Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Spherical Equivalent Refraction (SER)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Generation of random sequences, determination of random number grouping, and inclusion of subjects by different staff members.
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Multi-lens zoning myopia defocus Lens 1 (D.S.D.O)
干预措施: Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses (Device)
Multi-lens zoning myopia defocus Lens 2(D.S.D.O)
干预措施: Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses (Device)
结局指标
主要结局
Change in Spherical Equivalent Refraction (SER)
时间窗: From enrollment to the end of treatment at 12 months
次要结局
未报告次要终点
研究者
Mengtian Kang
Principal Investigator
Beijing Tongren Hospital