Myopia Control Effectiveness of Second-generation Defocus Incorporated Multiple Segments Spectacle Lenses on Fast Progressing Myopes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 118
- 试验地点
- 2
- 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 variant of Defocus Incorporated Spectacle lenses on controlling myopia progression in fast progressing myopic children.
详细描述
The variant of Defocus Incorporated Spectacle lenses (D2) is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.
Participants will be randomly allocated to either single vision lens group (control) or the variant of Defocus Incorporated Spectacle lens (D2) group (treatment). After 12 months of lens wear, the SV lens prescribed to the control group will be replaced with the D2 lens and be monitored for another 36 months. In parallel, the D2 treatment groups will continue their corresponding intervention for another 36 months. Their cycloplegic refraction and axial length will be monitored every 6 months over 4 years. The changes in refractive errors and axial length in two groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both participants and their guardians will be masked from the grouping. The outcomes assessors will be also masked from the grouping.
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: -0.75D or below in both eyes
- •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
- •For children aged 4-6 years without past prescription forms,
- •4-5 years old: myopia of -0.75D or below in both eyes
- •6 years old: myopia of -1.25D or below in at least one eye, with the other eye -0.75D or below
- •Best-corrected visual acuity (VA) in both eyes:
- •4 - 6 years old: 0.20 logMAR (or its equivalent) or better
- •7-12 years old: 0.00 logMAR (or its 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
Single vision lens group
Subjects in single vision lens group will receive a pair of single vision lenses for the first year of study. They will then receive a pair of DG2 lenses for an additional 3 years.
D2 lens group
Subjects in D2 lens group will receive a pair of D2 lenses over the 4-year study.
干预措施: Variant of Defocus Incorporated Spectacle lens (DG2) (Other)
结局指标
主要结局
Cycloplegic refraction change in spherical equivalent refraction (SER)
时间窗: Baseline, 1st year and 2nd year
Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline over a first 12-month period and a 12-month period of follow-up will be measured
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 for 4 years over the study period.
次要结局
- Axial length change(Baseline, 1st year and 2nd year)
- Axial length change(Baseline, every 6 months for 4 years)