Adverse Events Questionnaire for Low Dose Atropine Eye Drops
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Summary of adverse events by dose level at the time of the adverse event
研究概览
简要总结
Progressive myopia can lead to severe vision loss and is associated with retinal detachment, glaucoma, and other comorbidities. Several studies have shown that off-label, low-dose atropine eye drops slow the progression of myopia. Many eye care providers are now prescribing off-label atropine eye drops for their myopic patients, with the prescribed concentrations varying amongst providers.
The purpose of this study is to determine if low-dose atropine eyedrops used daily, cause adverse effects to the eyes. Patients currently using 0.01%, 0.03%, or 0.05% atropine eye drops obtained from compounding pharmacies will be assessed for associated adverse effects.
详细描述
Eligibility: Myopic patients currently using 0.01%, 0.03%, or 0.05% atropine eye drops, prescribed by the investigator(s).
Patients that meet the eligibility criteria will be given the parental consent form and child assent form (if applicable) during their regularly scheduled office visit. After consent forms are signed and at each follow-up visit, the investigator or study coordinator will begin by querying for adverse events by asking each patient general, non-directed questions, such as "How have you been feeling since the last visit?" Directed questioning and examination will then be done as appropriate. All reported adverse events will be documented on the appropriate CRF. The patients will then continue with their regular eye exam.
Patients enrolled in the study will be assessed for adverse events at each regularly scheduled office visit for the duration of the study (up to 5 years), unless they choose to withdraw from the study.
The study will assess 148 patients using either 0.01%, 0.03%, or 0.05% atropine eye drops (prescribed by the investigator), over a five-year period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients diagnosed with myopia
- •patients must be currently using 0.01%, 0.03%, or 0.05% atropine eye drops daily
- •low-dose atropine eye drops must be prescribed by the principal investigator and obtained from a compounding pharmacy
排除标准
- •patients without myopia
- •patients with myopia, but not using low-dose atropine eye drops
结局指标
主要结局
Summary of adverse events by dose level at the time of the adverse event
时间窗: up to 5 years
Summary of total adverse events and severity of adverse events, by dose level at time of the adverse event
次要结局
未报告次要终点