A Paired-Eye Comparison of Myopia Control Lenses in Myopic Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Eye Axial Length
研究概览
简要总结
The purpose of this clinical trial is to compare a new myopia control spectacle lens with a standard single vision spectacle lens in slowing the progression of myopia (nearsightedness) in healthy children aged 6 to under 11 years.
The main question being studied is:
Is the new myopia control spectacle lens more effective than a standard single vision spectacle lens in slowing myopia progression?
In this study, participants will wear a myopia control spectacle lens in one eye and a standard single vision spectacle lens in the other eye for the first 6 months. The lens assignment will then be switched between eyes for the remaining 6 months. Researchers will compare changes in eye axial length and refractive error between the two lens types.
Participants will:
- Wear the study spectacles for 12 months.
- Attend scheduled follow-up visits at the Essilor R&D Centre, Singapore.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer participant with the willingness and ability to comply with all scheduled study visits.
- •Informed consent of parent/guardian and assent of participant.
- •Age equal to or greater than 6 years and less than 11 years (before 11th birthday) at the time of consent.
- •Spherical equivalent refraction (SER) equal or less than -0.50 D and equal or greater than -4.75D with astigmatism not more than 2.00 D.
- •Difference in SER (anisometropia) between two eyes should not exceed 1.00 D.
- •Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR under high contrast in each eye.
- •Be in good general health, based on the participant and the parent's/guardian's knowledge.
- •Agree to wear the study spectacles for 12 hours per day and 7 days per week.
- •Agree not to be involved in other myopia control treatments.
排除标准
- •History of Atropine, Orthokeratology, Myopia Control Contact Lens, or Red Light treatment.
- •Strabismus by cover test at near or distance wearing correction.
- •History and presence of amblyopia.
- •Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.).
- •Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
- •History of ocular injury or surgery.
- •Participation in any clinical study within 30 days of the Baseline visit.
- •Current or anticipated use of growth hormones.
- •Study participants deemed inappropriate for the study by the investigator.
- •The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.
研究组 & 干预措施
OD: SVL; OS: MCL then OD: MCL; OS: SVL
Participants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months.
干预措施: Investigational Myopia Control Spectacle Lens (Device)
OD: SVL; OS: MCL then OD: MCL; OS: SVL
Participants will wear the investigational myopia control spectacle lens in the left eye and a standard single vision spectacle lens in the right eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months.
干预措施: Single Vision Spectacle Lens (Device)
OD: MCL; OS: SVL then OD: SVL; OS: MCL
Participants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months.
干预措施: Investigational Myopia Control Spectacle Lens (Device)
OD: MCL; OS: SVL then OD: SVL; OS: MCL
Participants will wear the investigational myopia control spectacle lens in the right eye and a standard single vision spectacle lens in the left eye for the first 6 months. After 6 months, the lens assignment will be switched, with each eye wearing the opposite lens type for another 6 months.
干预措施: Single Vision Spectacle Lens (Device)
结局指标
主要结局
Change in Eye Axial Length
时间窗: From baseline to 6 months
次要结局
- Change in Eye Axial Length(From 6 months to 12 months)
- Change in Eye Non-Cycloplegic Spherical Equivalent Refraction(From baseline to 6 months)
- Change in Eye Non-Cycloplegic Spherical Equivalent Refraction(From 6 months to 12 months)