NCT05174780已完成不适用
Clinical Evaluation of A Innovative Spectacle Lens in Slowing Myopia Progression
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 18
- 主要终点
- Axial length
研究概览
简要总结
The purpose of this study is to demonstrate that the test spectacle lens is safe and effective in slowing myopia progression in children.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Equal to or greater than 6 years and not older than 12 years at time of informed consent and assent.
- •Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.50 D in each eye.
- •Astigmatism, if present, of not more than 1.50 D.
- •Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
- •Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
- •Agree to wear spectacles for ≥10 hours/day at least 6 days/week.
- •Willingness and ability to participate in trial for 3 years and attend scheduled visits.
排除标准
- •History of myopia control intervention (e.g., atropine, orthokeratology, multifocal contact lenses, etc.)
- •Strabismus by cover test at near or distance wearing correction.
- •Amblyopia
- •Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.).
- •Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- •Current or anticipated use of growth hormones.
- •Participation in any clinical study within 30 days of the Baseline visit.
结局指标
主要结局
Axial length
时间窗: 36 Months
Change in axial length from baseline
Cycloplegic spherical equivalent refraction
时间窗: 36 Months
Change in cycloplegic spherical equivalent refraction from baseline
次要结局
- Axial length(24 Months)
- Cycloplegic spherical equivalent refraction(24 Months)
研究者
研究点 (18)
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