A Double-masked, Randomized, 2-armed Comparative Study of a Myopia Control Lens (Test Lens) Versus Single Vision Lens (Control Lens).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Axial Length
研究概览
简要总结
This is a monocenter, randomized, controlled, parallel-group, double-masked clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation at baseline compared to a single vision spectacle lens (control). A total of 80 children will be recruited where 40 subjects will be allocated either to wear test lenses (group 1) or control lenses (group 2) for 1 year through randomization.
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. A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.
This double masked parallel group study 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 (80 subjects) at the time of commencing treatment. As age of myopia onset is known to be an important factor in rate of myopia progression, subject age at the time of enrollment will be used to balance randomization. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuity will also be compared between test lenses and control lenses to determine the quality of vision using test 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
Subjects (and their parents/guardians) will be masked to the lens assignment. Sibling of subjects must be excluded due to the noticeable differences between the test and control spectacle lenses Only the statistician will be unmasked when comparing the two lenses. The investigator who is responsible for randomization and allocation will also be unmasked. However, the primary outcome variables (spherical equivalent refraction & axial length) will be taken by masked investigators. To facilitate this, the subject will be led into the room(s) containing a biometer without their study spectacles by the unmasked investigator.
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.
- •History of myopia control intervention
- •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.
- •Exclusion Criteria
- •Vulnerability of subject
- •Participation in any clinical study within 30 days of the Baseline visit.
- •Sibling of existing participant of this study
排除标准
- 未提供
结局指标
主要结局
Axial Length
时间窗: 12 months
Change in ocular axial length (mm) measured using Lenstar Optical Biometer.
次要结局
- Carry-over Effect(18 months and 24 months)
- Axial Length(6 months)
- Spherical Equivalent Refraction(6 months and 12 months)