跳至主要内容
临床试验/NCT03206723
NCT03206723Unknown2 期

Bandage Contact Lenses to Decrease Pain and Improve Healing in Emergency Department Subjects Presenting With Corneal Abrasions

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator
  1. Standard care

干预措施: Eyedrop (Drug)

Group 1

Active Comparator
  1. Standard care

干预措施: Hydrocodone (Drug)

Group 2

Active Comparator
  1. Standard care
  2. Bandage contact lens

干预措施: Bandage contact lens (Device)

Group 2

Active Comparator
  1. Standard care
  2. Bandage contact lens

干预措施: Eyedrop (Drug)

Group 2

Active Comparator
  1. Standard care
  2. 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

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Tanen

Professor of Clinical X

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

研究点 (1)

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