Efficacy of Autologous Fibrin Glue Versus Suture for Conjuntival Autografting in Primary Pterygium Surgery: a Randomized Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pterygium Recurrence
研究概览
简要总结
Pterygium is wing-shaped, vascular, fleshy growth that originates on the conjuntiva and that can spread to the corneal limbus and beyond The surgical exeresis with autologous conjunctival autograft technique is the treatment of choice. Commercially available fibrin glue has been used preferentially for graft fixation due to its benefits compared to sutures; However, its cost and the risk of inflammatory immune reaction limit the its use. There are few studies about autologous fibrin glue.
OBJECTIVE: To determine the efficacy of autologous fibrin glue preparation in patients undergoing pterygium resection surgery. To compare with autologous conjunctival graft fixation with suture.
This is a randomized clinical trial. Two patient groups will undergo pterygium excision surgery. Group 1 will have autologous conjunctival graft fixation with autologous fibrin glue and group 2 will have suture graft fixation using 10.0 mononylon. Early and late postoperative surgical results as well as complication rates will be analyzed.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •nasal primary pterygium
排除标准
- •relapsed pterygium
- •patients with a history of previous eye surgery
- •patients with glaucoma using hypotensive eye drops
- •eye surface diseases
- •eye allergy
- •diabetic patients,
研究组 & 干预措施
Autologous fibrin glue
干预措施: Autologous fibrin glue (Other)
Sutures
干预措施: Suture (Other)
结局指标
主要结局
Pterygium Recurrence
时间窗: 6 months
Recurrence in 6 months
次要结局
- Graft Edema(Postoperative day 1, 7, 21 and 30)
- Postoperative Pain(Postoperative day 1, 7, 21 and 30)
- Autograft Retraction(Postoperative day 1, 7, 21 and 30)