A Comparison Between Surgical Techniques for Securing Conjunctival Autografting in Primary Pterygium Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Recurrence Rate
研究概览
简要总结
Pterygium is a fibrovascular wing shaped encroachment of conjunctival fold on to the cornea with elastotic degeneration of a subconjunctival tissue, The standard treatment for pterygium is surgical excision, but the recurrence rate after surgery can be as high as 24%-89%, which compromises outcomes. Based on the simple excision of pterygium, multiple strategies and techniques have been developed to reduce the high rate of pterygium recurrence. The investigators aim was to compare the safety, efficacy, overall patient satisfaction and recurrence rate of suturing, fibrin gluing and sutureless glue-free technique for attaching conjunctival autograft in primary pterygium surgery.
详细描述
Design: Prospective randomized comparative interventional clinical study Setting: Assiut university hospital & El-Mabarah hospital for health insurance Methods: The study included 60 eyes of 60 consecutive patients of primary nasal pterygium were enrolled in the study. Simple excision under local anesthesia was performed then closure of the bare sclera by conjunctival autograft with fibrin glue in 20 eyes of 20 patients (group 1), versus sutured free conjunctival autograft in 20 eyes of 20 patients (group 2) ), versus sutureless and glue-free conjunctival autograft in 20 eyes of 20 patients (group 3).
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients complaining of primary Progressive nasal pterygium.
- •Patients with pterygium threatening the visual axis.
排除标准
- •Double head pterygium.
- •Pseudopterygium
- •Recurrent pterygium
- •Patients with history of any bleeding abnormalities
- •Patients with ocular surface diseases eg- blepharitis, Sjogren syndrome and dry eye.
研究组 & 干预措施
conjunctival autograft with fibrin glue
Conjunctival autograft with fibrin glue done for patients of group 1 after pterygium excision
干预措施: conjunctival autograft with fibrin glue (Procedure)
sutured conjunctival autograft
Sutured conjunctival autograft done for patients of group 2 after pterygium excision
干预措施: sutured conjunctival autograft (Procedure)
sutureless and glue-free conjunctival autograft
Sutureless, glue-free conjunctival autograft done for patients of group 3 after pterygium excision
干预措施: sutureless and glue-free conjunctival autograft (Procedure)
结局指标
主要结局
Recurrence Rate
时间窗: 6 months postoperatively
The main postoperative primary outcomes measure the recurrence rate
次要结局
- Postoperative discomfort(1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively)
- Graft stability(1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively)
- Postoperative inflammation(1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively)
- Complications(1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively)
- Overall patient satisfaction(1 day, 2 day, 1 week, 1 month 3 months and 6 months postoperatively)
研究者
Mohamed Fathy Ahmed Oraby
Specialist of ophthalmology, El-Mabarah hospital for Health insurance, Assuit, Egypt
Assiut University