Recurrence Rate of Mini-SLET (Simple Limbal Epithelial Transplantation) vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 主要终点
- Recurrence rate
研究概览
简要总结
To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and compare the clinical outcomes with conjunctival autograft
详细描述
Prospective Randomized Blind Clinical Trial
Sixty-four eyes of 64 patients with primary nasal pterygium have been operated by two surgeons (E. G-H, A. N-C). All patients are randomized to undergo Mini-SLET or limbal-conjunctival autograft transplantation as an adjuvant therapy after pterygium excision.
Four eyes were treated with Mini-SLET(group 1), and 26 eyes have been operated with conjunctival autograft (group 2). Patients will be followed up at 1 day, 1 week, 1, 3, 6, 9 and 12 months postoperation. The main outcome measurement was a recurrence rate after surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with primary nasal pterygium > 2mm
排除标准
- •Previous ocular surgery
研究组 & 干预措施
Mini-SLET
Simple Limbal Epithelial Transplantation
干预措施: Pterygium Excision (Procedure)
Limbal-Conjunctival Autograft
Patients treated with limbal-conjunctival autograft
干预措施: Pterygium Excision (Procedure)
结局指标
主要结局
Recurrence rate
时间窗: one day
Regrowth of pterygium
次要结局
未报告次要终点