Exploratory Study on the Effectiveness of Myopia Control Lenses in Slowing Myopia Progression in Young Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Axial length
研究概览
简要总结
This study will be a mono-center, single-arm, unmasked study evaluating the effectiveness of test lens in slowing myopia progression in children aged 6 to 8 years. The study aims to evaluate the change in axial elongation and spherical equivalent refraction in younger children who are fitted with the test lens over a 1-year period. A total of 25 children will be recruited.
详细描述
As myopia has become a global epidemic and public health concern, it is crucial to gain deeper insight to the possible treatments in slowing myopia progression. In a previous clinical trial, spectacle lenses with higher lenlets asphericity demonstrated effectiveness in reducing myopia progression and axial length elongation in children.
This clinical trial will assess the effectiveness of a test lens in slowing myopia progression in younger children over 1 year. Without compromising vision, the test lens is designed to modify the area and the amount of myopia defocus on the retina. The study population includes 25 children subjects in Singapore, aged 6 to 8 years during the commencement of the treatment. The axial length and spherical equivalent refraction will be the primary and secondary measures for myopia progression.
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
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent & assent form.
- •Equal to or greater than 6 years and less than 9 years at time of informed consent and assent.
- •Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 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)
- •Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
- •Absence of strabismus by cover test at near or distance wearing correction.
- •Absence of amblyopia
- •Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
排除标准
- •Vulnerability of subject
- •History of myopia control intervention
- •Participation in any clinical study within 30 days of the Baseline visit.
研究组 & 干预措施
Test myopia control lenses (BSL)
Test spectacle lens will be given to the subjects over 1 year.
干预措施: Test myopia control lenses (BSL) (Device)
结局指标
主要结局
Axial length
时间窗: 12 months
Evaluate the change in axial length (mm)
次要结局
- Axial length(6 months)
- Spherical Equivalent Refraction(6 months, 12 months)