Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression - Open Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Axial Length
研究概览
简要总结
This is a mono-centre, prospective, one-arm, unmask clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation compared to a single vision spectacle lens from the historical control group of another clinical trial NCT05331378. A total of 40 children will be recruited.
详细描述
As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial (Bao et al. 2022). A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.
This open clinical trial will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (40 subjects) at the time of commencing treatment. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuities will also be compared between test lenses and control lenses of the historical control group to determine the quality of vision using test lenses
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
- 8 Years 至 13 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 8 years and not older than 13 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)
Myopia control spectacle lenses (test lenses) will be given to subjects throughout the 24 months trial.
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 and 24 months
Change in ocular axial length (mm)
次要结局
- Axial Length(6 months and 18 months)
- Spherical Equivalent Refraction(6 months, 12 months, 18 months and 24 months)