Efficacy and Safety of Spectacle Lenses With Maximized Highly Aspherical Lenslets Target Technology (H.A.L.T. MAX) on High Myopia Control in Children and Adolescents: a Randomized Controlled Research
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- the proportion of change in SER of ≤ -0.75 (D)
研究概览
简要总结
Children aged 7-14 years with high myopia were randomly assigned to a control group or an intervention group at a 1:1 ratio. The intervention group wore H.A.L.T. MAX lenses for at least 10 hours per day for 2 years, and the control group wore ordinary single-vision (SV) spectacles for at least 10 hours per day. At the 1-year follow-up examination (6-month visit), control subjects whose equivalent spherical diopter change (SER) was ≥0.75 D were switched to H.A.L.T. MAX lenses until the end of year 2. After entering year 2, all remaining control (SV) subjects will be replaced with H.A.L.T. MAX defofocus frames for at least 10 hours per day until the end of year 2. And continue to wear it for at least 10 hours per day. To evaluate the efficacy, safety and compliance of H.A.L.T. MAX lenses in delaying myopia progression in children with high myopia, and to provide a scientific basis for the formulation and practice of public health programs for delaying myopia progression and the risk of blindness and visual impairment caused by high myopia.
详细描述
In a 2-year randomized controlled study, the intervention group wear H.A.L.T. MAX spectacle lenses for more than 10 hours a day for 2 years. During the first year, the control group wore conventional single-vision (SV) spectacles for at least 10 hours per day. At the 6-month follow-up visit, if the spherical equivalent refraction (SER) change in the control group (SV) participants was ≥0.75 D, they were switched to H.A.L.T. MAX spectacle lenses until the end of the second year. In the second year, all remaining control group (SV) participants were transitioned to H.A.L.T. MAX defocus spectacle lenses and continued wearing them until the study concluded. To evaluate the efficacy, safety and compliance of H.A.L.T. MAX lenses for delaying myopia in children with high myopia, and to provide a scientific basis for the development of prevention strategies for children with high myopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 7-14 years old);
- •7-14 years old，regardless of sex;
- •Spherical equivalent refraction (SE) after cyclopegia ≤ -5.00 D and ≥ -9.00D;
- •Anisometropia and Astigmatism ≤2.50D;
- •Best corrected distance visual acuity of at least 0.8 in both eyes;
- •Willing to wear only the spectacles provided by the investigator for all days (>10 hours) during the study without additional interventions;
- •Accept randomization;
- •Able to sign the informed consent form with the accompaniment and understanding of parents or guardians.
排除标准
- •Allergic or intolerant to cycloplegic drugs；
- •Exclude children on high dose atropine (1%) or red light therapy；
- •Any previous history of myopia control treatment in the previous 30 days, like low dose atropine, defocus spectacles, or thokeratology and acupuncture；
- •History or presence of an ocular disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, and cataract.；
- •History of eye surgery；
- •Ocular or systemic diseases that may be associated with myopia, such as Marfan syndrome, retinopathy of newborns, diabetes, etc；
- •Anatomic or skin factors affecting the wearing of spectacles；
- •Other conditions unsuitable for inclusion (patients with excessive expectations for the effect of the defocus spectacle lenses or desires to try other myopia interventions).
研究组 & 干预措施
the intervention group
the intervention group wore H.A.L.T. MAX for at least 10 hours a day for 2 years.
干预措施: H.A.L.T. MAX spectacles (Device)
The control group
The control group will wear single vision lenses (SV) for at least 10 hours a day. In the first year (at 6-month follow-up), study participants in the control group with a spherical equivalent diopter change (SER) of ≥0.75 D will be switched to H.A.L.T. MAX lenses until the end of year 2. After entering year 2, all remaining control (SV) study participants will be replaced with H.A.L.T. MAX spectacles for at least 10 hours per day until the end of year 2.
结局指标
主要结局
the proportion of change in SER of ≤ -0.75 (D)
时间窗: at the end of 1-year
the proportion of change in SER of ≤ -0.75 (D) at the end of 1-year in both groups
次要结局
- The proportion of change in AL of ≥ 0.34 mm(at the end of 1-year)