NCT01261455Unknown不适用
Prospective Randomized Pilot Study Comparing the Surgical Times Between Inferior Versus Superior Conjunctival Autografts for Primary Pterygia
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time taken to complete the surgical procedure (minutes)
研究概览
简要总结
The purpose of this study is to determine if there is any difference in the surgical time when the surgery is performed with a graft taken from under the upper lid versus lower lid. The investigators will also be recording the level of pain felt by patients after surgery, any difficulties during or after surgery, and if the pterygium grows back.
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
- •Ability to understand the nature of the procedure and to complete all measurement requirements
- •Patients must be eligible for either the superior or inferior conjunctival autografts (they must not meet any of the following exclusion criteria)
- •Adults (age >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
- •Patients with glaucoma or those who may need glaucoma surgery in the future
- •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)
结局指标
主要结局
Time taken to complete the surgical procedure (minutes)
时间窗: 1 year
次要结局
- Visual Analog Pain Score(1 week)
- Recurrence of pterygium(1 year)
- Intraoperative and Postoperative Complications(6 months)
研究者
研究点 (2)
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