Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 664
- 试验地点
- 13
- 主要终点
- Cumulative incidence of myopia (spherical equivalent by Myopia Master)
研究概览
简要总结
The aims of this clinical trial will test whether or not the onset of nearsightedness is delayed in a group of children randomized to nightly drops in 0.05% atropine in both eyes, in comparison to children who receiving nightly placebo drops in both eyes. The primary outcome is the two-year cumulative incidence of nearsightedness. The second aim of this project will determine whether atropine is associated with slower eye growth in children receiving nightly drops of atropine versus placebo.
详细描述
The "Delaying the Onset of Nearsightedness (DONUT) Study - Data Coordinating Center" is a randomized clinical trial designed to compare the effectiveness 0.05% atropine and a placebo in delaying the onset of nearsightedness. It is a multicenter (14 clinic centers) randomized clinical trial of 606 children (recruited over two years) ages 6 to 11 years who are determine to be at high risk of myopia onset, as measured by cycloplegic autorefraction and age. The primary outcome is the two-year cumulative incidence of myopia. The second aim of this project will determine whether atropine is associated with slower axial elongation in children receiving nightly drops of atropine versus placebo.
Participants will be seen every six months for at least two years to determine the onset of myopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Bottles to be distributed are masked at the pharmacy. Only pharmacy personnel and data coordinating center personnel have access to the assigned treatment groups.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Refractive Error (cycloplegic autorefraction, spherical equivalent, at least one eye, inclusive) 6 years: -0.74 D to +0.75 D 7 and 8 years: -0.74 D to +0.50 D 9 and 10 years: -0.74 D to +0.25 D 11 years: -0.74 D to plano
- •Neither eye has -0.75 D or more myopia, spherical component
- •Anisometropia: Less than 1.50 D difference between OD and OS, cycloplegic autorefraction, spherical equivalent
- •Astigmatism: Less than 1.50 DC in both eyes by cycloplegic autorefraction
- •Successfully complete run-in period: take at least 90% of unit dose artificial tears for 2 to 4 weeks (# of unit-dose vials used divided by # nights since baseline visit must equal 0.90 or greater)
排除标准
- •If Visit 2 (randomization visit) is not completed within 4 weeks of the baseline, eligibility visit.
- •Presence of strabismus (intermittent or constant) based on unilateral cover test at distance and near
- •Known allergy to atropine
- •Systemic issues that may affect accommodation or convergence (e.g., multiple sclerosis, myasthenia gravis, Graves ophthalmopathy, diabetes mellitus, Parkinson's disease, Down syndrome, etc.)
- •Ocular disease (e.g., congenital glaucoma, retinal disease, nystagmus, amblyopia, etc.)
- •Ocular surgery (e.g., cataracts, strabismus)
- •Any previous myopia prevention/control therapy (e.g., atropine, soft contact lenses, orthokeratology, myopia control spectacles, etc.) for more than one month
- •Pregnancy by self-report
研究组 & 干预措施
0.05% Atropine
0.05% atropine instilled in each eye nightly at bedtime
干预措施: Atropine Sulfate 0.05% Oph Soln (Drug)
Placebo
Placebo drops instilled in each eye nightly at bedtime
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative incidence of myopia (spherical equivalent by Myopia Master)
时间窗: Two years
Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo
Axial elongation (by Myopia Master)
时间窗: Two years
Axial elongation comparison between treatment and placebo
次要结局
- Time to event in incident myopes (measured by spherical equivalent by Myopia Master)(2 years)
- Progression of spherical equivalent (by Myopia Master)(2 years)