Efficacy and Safety of Low-concentration Atropine Eye Drops (0.02%, 0.04%) Combined With Defocus Incorporated Multiple Segments (DIMS) for Moderate and High Myopia Control
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.
详细描述
In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •School-age children aged 6 to 12 years (including boundary value)
- •Children with moderate or high myopia (subjective refraction after cycloplegia: -9.00D≤spherical equivalent (SE)≤-3.00D, with-rule astigmatism (C)≤2.00D, against-rule astigmatism (C)≤1.00D, anisometropia of both eyes≤2.50D)
- •Binocular best corrected visual acuity (BCVA)≥0.8 (five-point visual acuity 4.9)
- •Agree with the study scheme and sign the informed consent
- •Note: if both eyes meet the inclusion criteria, the eye with higher spherical equivalent is the study eye; if one eye meets the inclusion criteria, the eye is the study eye.
排除标准
- •Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in the past month; used red light treatment in the past
- •Children with obvious strabismus and amblyopia
- •With congenital eye disease, such as congenital cataract, congenital retinal disease
- •Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome)
- •Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.)
- •Refractive medium opacity (such as corneal disease, crystal opacity, etc.)
- •Bnormal intraocular pressure and clinical significance (IOP <10 mmHg or IOP >21mmHg or binocular IOP difference ≥5mmHg)
- •Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases
- •Optic nerve damage or congenital optic nerve dysfunction
- •Can not be regularly checked
- •The adjustment range is less than 8D or obvious near difficulties
- •Other reasons researchers think it is not suitable for inclusion in researchers
研究组 & 干预措施
The DIMS Group
wear DIMS ,and use placebo,once nightly, both eye
干预措施: DIMS (Device)
0.02% ATP
wear SP, and use 0.02%ATP eye drops, once nightly, both eye
干预措施: The 0.02% ATP Group (Drug)
0.04%ATP
wear SP, and use 0.04%ATP eye drops, once nightly, both eye
干预措施: The 0.04% ATP Group (Drug)
0.02%ATP+DIMS
wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye
干预措施: 0.02%ATP+DIMS (Combination Product)
0.04%ATP+DIMS
wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye
干预措施: 0.04%ATP+DIMS (Combination Product)
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: up to 24 months
Best Corrected Visual Acuity
次要结局
未报告次要终点
研究者
Ruihua Wei
Professor
Tianjin Medical University Eye Hospital