Evaluation of the Efficacy of Red Light in Adult Patients With High and Extreme Myopia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Axial length
研究概览
简要总结
This study, led by Jie ying from the Ophthalmology Department of Beijing Tongren Hospital Affiliated to Capital Medical University, is a researcher-initiated clinical trial (IIT) designed to evaluate the therapeutic efficacy of low-intensity red light therapy in adult patients with high myopia (spherical equivalent ≤ -6.00D) and extreme myopia (spherical equivalent ≤ -10.00D). With the escalating global prevalence of high and extreme myopia-especially in East Asia including China-and pathological myopia becoming a leading cause of irreversible blindness in Chinese adults, red light therapy has shown promising effects in slowing myopia progression in children but lacks clinical evidence for adult populations, which constitutes the core rationale for this research.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 45 years old. Spherical equivalent refraction of -6.00D to -20.00D in one or both eyes measured by cycloplegic computer optometry.
- •Intraocular pressure (IOP) ranging from 10 to 21 mmHg. Clear crystalline lens (cataract excluded). No active ocular inflammation, history of ocular trauma or surgery, and no ocular or systemic organic diseases that affect visual acuity changes.
- •Voluntarily participate in the study and sign the informed consent form. Willing to use the Tongren Myopia and Amblyopia Therapeutic Apparatus (Patent No.: 202022533301.4, manufactured by Hunan Yifan Technology Co., Ltd.) or accept the above-mentioned control treatment.
排除标准
- •Patients with the following ocular diseases: choroidal neovascularization, macular hemorrhage, macular schisis, extensive chorioretinal atrophy, and refractive media opacity (such as corneal lesions, lens opacity, etc.).
- •Subjects with systemic or immune diseases that affect compliance, including tumors, heart diseases (with implanted electronic devices such as cardiac pacemakers), severe hepatic and renal diseases, epilepsy, autoimmune diseases, etc.
- •Subjects with mental disorders that interfere with the implementation of intervention measures in this trial.
- •Hypersensitivity to cycloplegic agents. Other circumstances deemed inappropriate for participation in the trial by the investigator for safety reasons or the patient's benefit.
研究组 & 干预措施
Red light
干预措施: Red light (Device)
control
干预措施: Single vision spectacle lenses (Other)
结局指标
主要结局
Axial length
时间窗: Baseline, 3-month, 6-month, 9-month, 12-month
Sphearical equivalent error
时间窗: Baseline, 3-month, 6-month, 9-month, 12-month
次要结局
未报告次要终点
研究者
Ying Jie
Researcher
Beijing Tongren Hospital