NCT05815784进行中（未招募）2 期
Myopia Control in the Pediatric Population: a Comparison of MiSight, Naturalvue Multifocal, and Atropine 0.05%
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- axial length
研究概览
简要总结
This research project aims to provide additional knowledge of pharmacological and optical methods of myopia control and to gain a better understanding of the biometry of the pediatric eye, which contributes to the onset and progression of myopia. As a result, this study will improving our best practices for myopia control in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age of 5-12 years old at their baseline exam
- •Children with a spherical equivalent refractive error of +0.50D (minimal hyperopia) to -7.50 D (high myopia)
- •Gestational age ≥ 32 weeks.
- •Birth weight >1500g.
排除标准
- •Current or previous form of myopia control
- •Current or previous use of bifocal, progressive- addition lenses, or multifocal contact lenses
- •Known atropine allergy or contact lens intolerance (allergy to only one can still allow enrollment in the other group)
- •Abnormality of cornea, lens, central retina, iris, or ciliary body
- •Current or prior history of manifest strabismus, amblyopia, or nystagmus
- •Current or previous myopia treatment with atropine, pirenzepine or another anti-muscarinic agent.
- •Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
- •Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
- •Abnormality of the cornea, lens, central retina, iris, or ciliary body.
- •Prior eyelid, strabismus, intraocular, or refractive surgery.
- •Down syndrome or cerebral palsy.
- •Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Grave's disease, myasthenia gravis, diabetes mellitus, Parkinson's disease)
- •Existing ocular conditions (e.g., retinal disease, cataracts, ptosis) or systemic/neurodevelopmental conditions (e.g., Down syndrome) which may influence refractive development
- •Any condition that in the judgement of the investigator could potentially influence refractive development.
- •Existing conditions that may affect the long-term health of the eye or require regular pharmacologic treatment that may adversely interact with study medication (e.g., JIA, glaucoma, diabetes mellitus, pre-diabetes)
- •Inability to comprehend and/or perform any study-related clinical tests
研究组 & 干预措施
Atropine
Other
0.05% atropine. One drop per eye per day for 2 years.
干预措施: Atropine (Drug)
MiSight contact lenses
Other
MiSight contact lenses. Daily wear for 2 years.
干预措施: MiSight contact lenses (Device)
结局指标
主要结局
axial length
时间窗: 2 years
change in axial length (as measured by biometry) over a 2-year time period
Refractive error
时间窗: 2 years
change in refractive error over a 2-year time period
次要结局
- compliance with treatment(2 years)
- reported side effects(2 years)
- success rate of contact lens fitting in the younger children(2 years)
- contact lens tolerance in the younger children(2 years)
研究者
Magdalena Stec
Assistant Professor of Ophthalmology
Ann & Robert H Lurie Children's Hospital of Chicago
研究点 (1)
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