Myopia Control Using Optimized Optical Defocus in Schoolchildren - a Randomized Double Masked Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Cycloplegic Refraction Change in SER
研究概览
简要总结
The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.
详细描述
The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.
The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.
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
- Double (Participant, Investigator)
盲法说明
Double masked design:
The investigator(s) who were responsible for refracting and performing relevant ocular data measurement were masked from the grouping of the subjects.
The unmasked investigator(s) were responsible for group allocation, spectacle-dispensing work, measuring lens visual performance, record keeping, data entry and compliance checking. Data input was carefully checked by the unmasked investigator and the other researchers independently.
The children and their parents were also masked to group allocation until the data analysis was completed.
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at enrolment: 8-13 year; Hong Kong Chinese
- •Spherical equivalent refractions (SER): -1.00 to -5.00D
- •Astigmatism: -1.00D or less
- •Anisometropia: 1.25D or less
- •Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
- •Contact lens corrected monocular VA: 0.1 logMAR or better
- •Normal binocular function
- •Willingness to wear contact lenses regularly
- •Parents' understanding and acceptance of random allocation of grouping and masking
排除标准
- •Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
- •Strabismus or decompensated phoria (checked by cover test at far and near in screening)
- •Known contraindications for contact lens wear
- •Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development
结局指标
主要结局
Cycloplegic Refraction Change in SER
时间窗: 12 months
Change in cycloplegic autorefraction in spherical equivalent (SER)
次要结局
- Axial length(12 months)
研究者
Carly Lam
Professor
The Hong Kong Polytechnic University