Delaying the Onset of Nearsightedness Until Treatment Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Compliance percentage
研究概览
简要总结
Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.
详细描述
Participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. These children will be randomized for a pilot study measuring compliance in nightly eye drop administration. The outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
De-identified bottles will be sent to the sites with randomization codes. The key will be kept at the data coordinating center.
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
- •Age: 6-11 years
- •Refractive error measured in spherical equivalent, one eye meets criterion
- •6 years old: 0.50 to +0.38
- •7 years old: 0.50 to +0.25
- •8-11 years old: 0.50 to plano
- •Anisometropia: spherical equivalent <1.50 D
- •Astigmatism: <1.50 in both eyes
- •Myopia: Less myopic than -0.74 D, both eyes
排除标准
- 未提供
研究组 & 干预措施
0.01% Atropine
0.01% atropine eye drops
干预措施: Atropine Ophthalmic (Drug)
0.03% Atropine
0.03% atropine eye drops
干预措施: Atropine Ophthalmic (Drug)
0.05% atropine
0.05% atropine eye drops
干预措施: Atropine Ophthalmic (Drug)
结局指标
主要结局
Compliance percentage
时间窗: 30 days
A comparison of the compliance percentage with eye drop administration
次要结局
未报告次要终点
研究者
Jeffrey J. Walline, OD PhD
Associate Dean for Research, College of Optometry
Ohio State University