Low-dose Atropine for the Prevention of Myopia Progression in Danish Children - a Randomized, Double-masked, Multicenter, 36-month Prospective 1:1:1 Study of Safety and Efficacy of 0.1% Atropine Loading Dose to Single 0.01% Atropine and Placebo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 3
- 主要终点
- Axial Length at 36 Months
研究概览
简要总结
Myopia (nearsightedness) is increasing in prevalence throughout the world. It is associated with a risk of potentially blinding complications such as retinal detachment and myopic maculopathy. There is a direct association between the degree of myopia and the risk of complications. Myopia develops in childhood and during adolescence. To prevent higher degrees of myopia, we need to halt disease progression in children and teenagers. Low-dose atropine eye drops have been shown to reduce myopia progression by 50% in Asian populations but its effect in non-Asian populations is unknown. The aim of this study is to investigate if low-dose atropine can reduce myopia progression in Danish children and teenagers. The study is an investigator initiated randomized clinical trial conducted as a collaboration between three Danish Eye Departments covering all of Denmark.
详细描述
The main hypotheses tested in this study are:
- 0.01% atropine one drop nightly reduces the progression of childhood myopia in Danish children.
- 0.01% atropine one drop nightly is safe and with no significant side effects.
- A 6-month loading dose of 0.1% atropine followed by a 0.01% atropine maintenance dose is superior to single 0.01% atropine.
- 0.1% atropine one drop nightly is safe and has tolerable side effects.
- The rebound effect after stopping both atropine regimens is limited.
- Choroidal thickness is a predictor for the progression of childhood myopia.
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
- •Children aged ≥6-<9 years: myopia ≤-1 (spherical power) in at least one eye
- •Children aged ≥9-≤12 years: myopia ≤-2 (spherical power) in at least one eye
- •Cylinder less than 1.5 diopters
排除标准
- •Myopia related to retinal dystrophies
- •Collagen syndroms (Ehlers-Danlos syndrome, Marfan syndrome and Stickler syndrome)
- •Other ocular pathology (e.g., amblyopia, strabismus)
- •Previous eye surgery
- •Previous use of agents thought to affect myopia progression, e.g. atropine, pirenzepine or 7-methylxanthine (metabolite of caffeine and theobromine) and orthokeratology contact lenses
- •Known allergy to atropine or any of the contents of the trial medication (active and in-active ingredients) used in the study
- •Non-compliance to eye examinations
- •Serious systemic health troubles (e.g., cardiac or respiratory illness) and developmental disorders and delays
研究组 & 干预措施
Loading dose
In phase 1 (treatment phase), the participants (n=33) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime.
In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
干预措施: 0.1% atropine and 0.01% atropine (Drug)
Low dose
In phase 1 (treatment phase), the participants (n=32) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime.
In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
干预措施: 0.01% atropine (Drug)
Placebo
In phase 1 (treatment phase), the participants (n=32) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime.
In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
干预措施: 0.9% Sodium-chloride (Drug)
结局指标
主要结局
Axial Length at 36 Months
时间窗: 36 months
Treatment group comparison of axial length at 36 months, as measured using IOLMaster 700
Spherical Equivalent at 36 Months
时间窗: 36 months
Treatment group comparison of spherical equivalent at 36 months, as measured using cycloplegic autorefraction
次要结局
- Adverse Events(36 months)
- Change in Choroidal Thickness From Baseline to 36 Months(36 months)
研究者
Line Kessel
Consultant ophthalmologist, Associate Professor, MD, Ph.D., FEBO
Rigshospitalet, Denmark