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
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 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)
研究组 & 干预措施
Patch
Active Comparator
The operative eye will be patched.
干预措施: Patch or bandage contact lens (Procedure)
Bandage Contact Lens
Experimental
The operative eye will have a bandage contact lens
干预措施: Patch or bandage contact lens (Procedure)
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 (1)
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