Bandage Contact Lenses to Decrease Pain and Improve Healing in Emergency Department Subjects Presenting With Corneal Abrasions
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain scale
研究概览
简要总结
Two percent of all patients presenting to the Emergency Departments have complaints involving the eye. Corneal abrasions are a common diagnosis with patients with eye pain and often cause significant discomfort. Current treatment includes a thorough evaluation of the eye followed by patching, empiric antibiotics, cycloplegics and oral pain medicines. This study will be a randomized controlled trial to determine the safety and efficacy of BCLs. It will involve the initial patient evaluation followed by a return visit to the Emergency Department within 36 hours for re-examination. At each visit, the patient will be assessed for the size and location of the abrasion along with their report of pain using a visual analog scale. Data will be recorded on a standard data collection sheet. Telephone contact will be made at 30 days to ensure resolution of abrasion and that no complications ensued.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between ages 18-65 years who present to the emergency department.
- •Traumatic corneal abrasion not associated with contact lens use or communicating or adjacent wounds to the eye.
排除标准
- •Pregnant women
- •Breast-feeding women
- •Corneal abrasion associated with the wearing contact lenses
- •Evidence of corneal ulcer, glaucoma or other ocular pathology, monocular vision
- •Wound healing deficits such as collagen vascular disease or concomitant steroid use
- •Use of other ocular medications, dry eyes, blepharitis
- •Systemic infections
- •Known allergies to medicines used in the study
研究组 & 干预措施
Group 1
- Standard care
干预措施: Eyedrop (Drug)
Group 1
- Standard care
干预措施: Hydrocodone (Drug)
Group 2
- Standard care
- Bandage contact lens
干预措施: Bandage contact lens (Device)
Group 2
- Standard care
- Bandage contact lens
干预措施: Eyedrop (Drug)
Group 2
- Standard care
- Bandage contact lens
干预措施: Hydrocodone (Drug)
结局指标
主要结局
Pain scale
时间窗: 24 hours post treatment
The pain difference using Visual Analogue Scale
次要结局
- Corneal defect size(24 hours post treatment)
- Pain medication needed(24 hours post treatment)
研究者
David Tanen
Professor of Clinical X
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
