A Prospective Randomised Controlled Trial to compare the efficacy and outcome of Autologous blood and Fibrin glue for conjunctival autograft adherence in Sutureless Pterygium surgery

Dr Abraham Kurian1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2012年1月30日最近更新: 2019年4月5日

试验速览

阶段: 不适用
状态: 已完成
发起方: Dr Abraham Kurian
入组人数: 200
试验地点: 1
主要终点: 2)Recurrence

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomised controlled,parallel group interventional single centre trial to compare the efficacy and outcome of Autologous blood and fibrin glue for conjunctival graft adherence in sutureless pterygium surgery, in 200 patients with primary pterygia. The patients are randomly assigned to two groups-Group I - using autologous blood and Group II - using fibrin glue.The primary outcome measures will be the graft adherence assessed at 1 day and 1 week and recurrence at 1 year postoperatively. Secondary outcome measures will be incidence of graft related complications at 1 day, 1 week and 1 month postoperatively.

研究设计

研究类型: Interventional
分配方式: Permuted block randomization, fixed
盲法: Participant Blinded

入排标准

年龄范围: 18.00 Year(s) 至 80.00 Year(s)（—）
性别: All

入选标准

•Clinically significant primary pterygia.

排除标准

•Recurrent Pterygium 2)Patients with significant ocular surface disease 3)Patients with known hypersensitivity to fibrin glue or any of its components 4)Patients on Anticoagulants or antirheological agents (as these are thought to have an adverse effect on the adherence of the graft with autologous blood).

结局指标

主要结局

2)Recurrence

时间窗: 1)1 day,1 week | 2)1 year

1)Graft adherence

时间窗: 1)1 day,1 week | 2)1 year

次要结局

Complications like Graft retraction,Subconjunctival haemorrhage(1 day,1 week,1month)

研究者

发起方

Dr Abraham Kurian

申办方类型

Other [Principal Investigator]

研究点 (1)

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