NCT01249235Unknown不适用
Prospective Randomized Controlled Trial Comparing Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual Analog Pain Score
研究概览
简要总结
The purpose of this study is to determine if patching the eye or a bandage contact lens along with Tylenol #3 is more effective for pain control following pterygium surgery.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary pterygium (no previous surgeries or radiotherapy) requiring excision due to ocular discomfort or disruption in vision
- •Size of pterygium greater than 2.5 mm over the cornea (pterygia smaller than this do not result in much postoperative eye pain)
- •Ability to understand the nature of the procedure and to complete all measurement requirements
- •Adults (age greater than 18)
排除标准
- •Ocular surface disease apart from pterygium (such as severe dry eye, corneal disease, scarring from previous infection, radiotherapy, inflammatory diseases or trauma)
- •Patients who have had previous ocular surface surgery
- •Contraindications to local anesthetics (such as known allergy)
- •Pregnancy (as the risk to the fetus with the use of topical antibiotic drops and local anesthetics are not known)
- •Patients already on systemic analgesics for any other reason (such as rheumatoid arthritis)
- •Allergy to codeine (in order to standardize the systemic analgesic used so that we can compare the effect of bandage contact lens versus 24 hour patching)
结局指标
主要结局
Visual Analog Pain Score
时间窗: 1 week
次要结局
- Sensitivity to light, tearing, foreign body sensation(1 week)
- Postoperative Complications(1 week)
- Number of Tylenol #3 tablets required(1 week)
研究者
研究点 (2)
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