A Randomized, Crossover Controlled Trial of the Effect of TAMER Lenses Versus Single Vision Lenses on Myopic Progression in Myopic Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Spherical Equivalent change
研究概览
简要总结
This study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 Chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of TAMER lenses in myopia control as compared to singlie vision lenses.
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
- Single (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
- 否
入选标准
- •Race: Chinese children and adolescents.
- •Age 6-12 years, gender unrestricted.
- •Cycloplegic refraction SER: -0.75DS~-5.0DS in both eyes.
- •Best corrected visual acuity of both eyes reaches 0.8 (0.00 logMAR).
- •Cylinder power and astigmatism are no more than 1.5D.
- •During the study period, willing to wear glasses provided by the researcher only and without additional interventions.
- •Willing to be randomly assigned.
- •Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.
排除标准
- •Allergic or intolerant to medications used for cycloplegia.
- •Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within half a year before the study.
- •Diagnosed with any eye disease other than nearsightedness, including strabismus, corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
- •History of eye surgery (including strabismus correction surgery).
- •Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
- •Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
- •Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.
研究组 & 干预措施
Group A
TAMER lenses are used first for 6 months, followed by SV lenses for 6 months.
干预措施: TAMER Lens Spectacle (Device)
Group A
TAMER lenses are used first for 6 months, followed by SV lenses for 6 months.
干预措施: SV lenses (Device)
Group B
SV lenses are used first for 6 months, followed by TAMER lenses for 6 months.
干预措施: TAMER Lens Spectacle (Device)
Group B
SV lenses are used first for 6 months, followed by TAMER lenses for 6 months.
干预措施: SV lenses (Device)
结局指标
主要结局
Spherical Equivalent change
时间窗: 6 months
cycloplegic SE change
次要结局
- Axial Length change(6 months)
- Spherical Equivalent change(12 months)