Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- postoperative pain 24 hours after conjunctival flap
研究概览
简要总结
During conjunctival flap surgery the corneal epithelium is removed and a conjunctival flap is placed on the cornea and after a few weeks the conjunctiva covers the surface of the eye.
Complications of this operation are flap retraction, conjunctival inclusion cysts, bleeding, infection and pain. Pain is one of the main complications of conjunctival flap surgery. Two sources are conceivable for pain: 1) conjunctival pain 2) corneal pain, the second of which is the main part of the pain.
Numerous methods for controlling corneal pain have been reported in various articles. Eye patches are often recommended for the treatment of corneal abrasions despite the lack of evidence. Recommended analgesics to control corneal scratch pain include nonsteroidal anti-inflammatory drugs (NSAIDs), local anesthetics, and topical cycloplegias.
In this article, we are going to review and evaluate a new method called corneal neuorotomy, i.e., corneal nerve endings that inserted radially can be cut to reduce postoperative pain.
详细描述
The main idea of this randomized clinical trial is to test the extent of pain relief after incision of radial corneal nerve endings.
Patients are divided into two groups. In the first group, the same classic method of conjunctival flap surgery was used and in the second group, conjunctival flap surgery was performed adjuncted by cutting the radial superficial nerves of the cornea. The postoperative pain scores of these two groups will be measured using visual analogue scale, after 6 hours, 24 hours and 48 hours, and finally the average pain of the two groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •VLE (vision loss eye)Patients who are candidates for prosthesis implantation
排除标准
- •1 painful vision loss eye
- •2 Patients who are candidates for conjunctival flap with indications other than implant placement (such as pain due to corneal ulcers, etc.)
结局指标
主要结局
postoperative pain 24 hours after conjunctival flap
时间窗: 24 hours after surgery
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
postoperative pain 6 hours after conjunctival flap
时间窗: 6 hours after surgery
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
postoperative pain 48 hours after conjunctival flap
时间窗: 48 hours after surgery
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
次要结局
未报告次要终点
研究者
Nasser Karimi
Principal Investigator, Assistant Professor
Iran University of Medical Sciences