Bandage Contact Lens Application for the Management of Corneal Abrasion in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Pain Score
研究概览
简要总结
The researchers are trying to understand if the application of a bandage contact lens results in better relief than usual treatment for a corneal abrasion.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Superficial Corneal Abrasion
排除标准
- •Incarceration
- •Pregnancy
- •Inability to Provide Informed Consent
- •Infectious keratitis
- •Retained foreign bodies in the eye
- •Active infection involving the orbit or periorbital region
- •Patients who are not able to or who are deemed unlikely to follow-up with ophthalmology
- •A history or recent contact lens wear
- •A lack of trauma or an unclear history of trauma as the inciting cause of the abrasion
- •Allergy to the antimicrobial solution (POLYTRIM)
- •Women who are currently breastfeeding
- •Chronic eye drop use
- •A history of eye surgery other than cataract surgery (greater than 6 months prior to abrasion)
- •Diabetes (Patients with even mild diabetic neuropathy can have decreased pain sensation and also delayed corneal epithelial healing)
- •Any eye condition that may be deemed to interfere with the conduct of the protocol or outcome measurement.
研究组 & 干预措施
Bandage Contact Lens (BCL) group
Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have a bandage contact lens soaked in antibiotic solution placed in the affected eye
干预措施: Air Optix contact lens (Device)
Usual Care Group
Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department
结局指标
主要结局
Change in Pain Score
时间窗: Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge
Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible
次要结局
未报告次要终点
研究者
Robert J. Hyde
Principal Investigator
Mayo Clinic