Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial (DONUT)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Lisa A Jordan, PhD
- 电话号码：614-247-7321
- 邮箱：jordan.646@osu.edu
学习地点
-
-
Alabama
-
Birmingham、Alabama、美国、35233
- 招聘中
- University of Alabama School of Optometry
-
接触：
- Sindhu Gurrala
- 电话号码：205-975-3881
- 邮箱：OPT-donutstudy@uab.edu
-
-
California
-
Berkeley、California、美国、94720
- 招聘中
- University of California, Berkeley, School of Optometry
-
接触：
- Yoofi Mensah
- 电话号码：510-207-4758
- 邮箱：donut@berkeley.edu
-
Fullerton、California、美国、92831
- 招聘中
- Southern California College of Optometry at Marshall B. Ketchum University
-
接触：
- Susan Parker
- 电话号码：714-463-7580
- 邮箱：research@ketchum.edu
-
Palo Alto、California、美国、94303
- 招聘中
- Stanford University
-
接触：
- Joellen Leonard
- 电话号码：650-498-0842
- 邮箱：Robertsvisionlab@stanford.edu
-
-
Illinois
-
Chicago、Illinois、美国、60616
- 招聘中
- Illinois College of Optometry
-
接触：
- Jessica Martinez
- 电话号码：312-949-7340
- 邮箱：Research@ico.edu
-
-
Indiana
-
Bloomington、Indiana、美国、47405
- 招聘中
- Indiana University
-
接触：
- Amy Peterson, OD
- 电话号码：812-856-0242
- 邮箱：peteramy@iu.edu
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- 招聘中
- New England College of Optometry
-
接触：
- Tamara Khanjyan
- 电话号码：617-587-5723
- 邮箱：donutstudy@neco.edu
-
-
New York
-
New York、New York、美国、10036
- 招聘中
- State University of New York College of Optometry
-
接触：
- Keyana Hunte
- 电话号码：212-938-4052
- 邮箱：clinicresearch@sunyopt.edu
-
-
Ohio
-
Cleveland、Ohio、美国、44106
- 尚未招聘
- Case Western Reserve Department of Ophthalmology
-
接触：
- Adam J Peiffer, OD
- 电话号码：440-684-1743
- 邮箱：adam.peiffer@uhhospitals.org
-
Columbus、Ohio、美国、43210
- 招聘中
- The Ohio State University College of Optometry
-
接触：
- Alexis Koston
- 电话号码：614-292-0200
- 邮箱：OPT-DonutStudy@osu.edu
-
-
Pennsylvania
-
Elkins Park、Pennsylvania、美国、19027
- 招聘中
- Pennsylvania College of Optometry at Drexel University
-
接触：
- Asami Kojima
- 电话号码：215-276-6053
- 邮箱：donutstudy@drexel.edu
-
-
Tennessee
-
Memphis、Tennessee、美国、38104
- 招聘中
- Southern College of Optometry
-
接触：
- Elaine Turcotte
- 电话号码：901-730-5004
- 邮箱：eturcotte@sco.edu
-
-
Texas
-
Houston、Texas、美国、77004
- 招聘中
- University of Houston College of Optometry
-
接触：
- Onose Okoeguale
- 电话号码：713-743-1994
- 邮箱：donut@uh.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：0.05% Atropine
0.05% atropine instilled in each eye nightly at bedtime |
Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy |
|
安慰剂比较：Placebo
Placebo drops instilled in each eye nightly at bedtime |
Placebo drop with same formulation as treatment minus the atropine |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative incidence of myopia (spherical equivalent by Myopia Master)
大体时间：Two years
|
Cumulative incidence of myopia as measured by cycloplegic autorefraction comparison between treatment and placebo |
Two years
|
|
Axial elongation (by Myopia Master)
大体时间：Two years
|
Axial elongation comparison between treatment and placebo |
Two years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to event in incident myopes (measured by spherical equivalent by Myopia Master)
大体时间：2 years
|
A comparison of the time to myopia onset between the treatment and placebo groups |
2 years
|
|
Progression of spherical equivalent (by Myopia Master)
大体时间：2 years
|
Spherical equivalent progression (change) comparison between treatment and placebo |
2 years
|
合作者和调查者
调查人员
- 学习椅：David A Berntsen, OD PhD、University of Houston College of Optometry
- 学习椅：Jeffrey J Walline, OD PhD、The Ohio State University College of Optometry
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- DONUTCT
- UG1EY037202 (美国 NIH 拨款/合同)
- UG1EY037201 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The final dataset to be shared will include self-reported demographic and participant activity and compliance to treatment data from interviews with participants' parent or guardian, eye examination data, and refraction data. The investigators will share de-identified individual-participant level (IPD) data. Appropriate measures such as providing only participant age and not providing clinical site of data collection will be used for data de-identification and sharing, and informed consent forms will reflect those plans. Calculated fields, rather than the component fields, will be available for a more accessible dataset.
IPD 共享时间框架
Shared data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be a minimum of 10 years after the contribution of the data to Vivli.
IPD 共享访问标准
Data will be available for access on Vivli.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.