Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes - Auxiliary Group
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Cycloplegic refraction change in spherical equivalent refraction (SER)
研究概览
简要总结
The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) and a variant of DIMS (D2) spectacle lenses on controlling myopia progression in fast progressing myopic children.
详细描述
DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.
Participants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over the first 2 years. They will then be prescribed with a pair of D2 spectacle lens for an additional 2 years. D2 is the variant of Defocus Incorporated Spectacle lenses. It is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SER: -1.00D or below
- •Documented history of fast progressing myopia, either in SER or AL
- •SER progression: 0.50D/year or more
- •AL elongation: 0.27mm/year or more
- •Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better
- •Acceptance of random group allocation and the masked study design
- •Anisometropia of 1.50 D or less
- •Astigmatism of 2.00 D or less
排除标准
- •Strabismus and binocular vision abnormalities
- •Ocular and systemic abnormalities
- •Prior experience of myopia control
研究组 & 干预措施
DIMS to D2 lens group
Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months. They will then wear a pair of D2 spectacle lenses for an additional 24 months.
干预措施: DIMS spectacle lens (Other)
结局指标
主要结局
Cycloplegic refraction change in spherical equivalent refraction (SER)
时间窗: Baseline, every 6 months for 4 years
Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months over the 4-year study will be measured
次要结局
- Axial length change(Baseline, every 6 months for 4 years)