A Multicenter Randomized Controlled Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens in the Treatment of Ultra-high Myopia in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Axial length
研究概览
简要总结
The rigid scleral contact lens with optical multi-focal design adopted in this study can focus the light in part of the optical area on the front of the retina to form myopic defocus, in order to delay the axial changes in children and adolescents with ultra-high myopia. In this study, RGP was used as a control, and a multicenter, randomized, controlled trial was conducted to verify the safety and effectiveness of multifocal scleral contact lenses for the correction of ultra-high myopia in children and adolescents.
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
- None
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to understand and sign the informed consent when accompanied by parents or guardians.
- •Age from 8 years old to15 years old.
- •The equivalent spherical lens of both eyes after ciliary muscle paralysis is -5.00D to -20.00D, the astigmatism is ≤-3.50D.
- •Willing to wear hard contact lenses, and able to wear only the hard contact lenses provided by the study as required and ensure adequate wearing duration.
- •(6) Best corrected visual acuity of both eyes ≥ 0.8.
排除标准
- •(1) Allergic or intolerant to rigid contact lens or its care products or ciliary muscle paralysis drugs.
- •Strabismus and/or amblyopia. (3) Those who have worn hard contact lenses in the past 30 days are using atropine, defocus frame lens, bifocal lens or progressive lens, acupuncture, etc. for myopia treatment.
- •(4) Any clinically significant active eye disease, such as glaucoma, uveitis, chorioretinitis, central retinal artery or vein occlusion, and so on.
- •(5) Patients with systemic diseases that may affect the wearing of hard contact lenses, such as hyperthyroidism, diabetes, mental illness, and so on.
- •(6) are using drugs that affect their eye health. (7) History of eye injury or surgery. (8) Incapacitated or unable to follow the visitor as required. (9) Other conditions not suitable for inclusion as judged by the investigator.
研究组 & 干预措施
Multi-focal rigid scleral contact lens
During the study period, subjects will wear a multi-focal rigid scleral contact lens daily.
干预措施: Multi-focal rigid scleral contact lens (Device)
Rigid gas permeable contact lens
During the study period, the subjects will wear rigid contact lenses daily
干预措施: Rigid gas permeable contact lens (Device)
结局指标
主要结局
Axial length
时间窗: 2 years
Two-year change in axial length
次要结局
- changes of spherical equivalent(2 years)