A Randomized Controlled Study of Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Axial length elongation
研究概览
简要总结
Peripheral contact lens in controlling myopia progression in high myopia children（PAM）is a prospective, single-center, randomized controlled trial with three parallel arms conducted at Beijing Tongren Hospital. Chinese children aged 6-12 years with high myopia (spherical equivalent ≤-6.0D) and annual progression ≥0.75D will be enrolled. Participants will be randomized 40:40:40 to: (1) combination therapy group receiving atropine 0.04% plus soft peripheral defocus contact lenses; (2) atropine monotherapy group receiving atropine 0.04% plus spectacles; or (3) control group receiving atropine 0.01% plus spectacles. The primary outcome is change in axial length and cycloplegic refraction at 24 months. Secondary outcomes include changes in pupil diameter, and safety parameters.
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)
盲法说明
Generation of random sequences, determination of random number grouping, and inclusion of subjects by different staff members.
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mainland Chinese children aged 4-16 years at enrollment
- •Spherical equivalent refraction ≤-6.0D in both eyes under cycloplegia
- •Astigmatism ≤2.5D in both eyes
- •Anisometropia ≤2.5D
- •Best corrected visual acuity ≥0.1 logMAR in both eyes
- •Subject-reported non-significant ocular and systemic medical history
- •Ability and willingness to wear contact lenses (for intervention groups)
- •Written informed consent from parents/guardians and assent from child
- •Ability to attend all scheduled follow-up visits
排除标准
- •Previous use of myopia control treatments (atropine, orthokeratology, multifocal lenses) within 3 months
- •Current use of systemic medications affecting pupil size or accommodation
- •Known allergies to atropine or contact lens materials
- •Current use of systemic medications that may significantly affect contact lens wear, tear film production, pupil size, adaptability, or refractive status.
- •Ocular diseases: strabismus, amblyopia, glaucoma, cataract, corneal disease
- •Systemic diseases affecting ocular health
- •History of ocular surgery or trauma
- •Inability to perform study procedures
- •Participation in other clinical trials within 2 months
研究组 & 干预措施
combination therapy group
40 patients in combination therapy group received atropine 0.04% plus soft peripheral defocus contact lenses
干预措施: soft peripheral defocus contact lenses (Device)
combination therapy group
40 patients in combination therapy group received atropine 0.04% plus soft peripheral defocus contact lenses
干预措施: Atropine 0.04% (Drug)
atropine monotherapy group
40 patients in atropine monotherapy group received atropine 0.04% plus spectacles
干预措施: Atropine 0.04% (Drug)
atropine monotherapy group
40 patients in atropine monotherapy group received atropine 0.04% plus spectacles
干预措施: Single Vision Spectacles (Device)
control group
40 patients in control group received atropine 0.01% plus spectacles
干预措施: Atropine (0.01%) (Drug)
control group
40 patients in control group received atropine 0.01% plus spectacles
干预措施: Single Vision Spectacles (Device)
结局指标
主要结局
Axial length elongation
时间窗: from baseline to 24 months
Axial length will be measured using the IOLMaster 500 optical biometry system (Carl Zeiss Meditec, Jena, Germany). To ensure measurement reliability and minimize random error, five consecutive measurements will be obtained for each eye at each visit, with individual measurements required to have a signal-to-noise ratio ≥2.0. The mean value of these five measurements will be calculated and used for analysis. Measurements will be standardized by time of day, conducted between 1:00 PM and 5:00 PM at all visits to minimize the influence of diurnal variations in axial length.
次要结局
- Change in cycloplegic spherical equivalent refraction(Baseline, 6 months, 12 months, 18 months, and 24 months.)
研究者
Mengtian Kang
attending physician
Beijing Tongren Hospital