Comparative Analysis of Recurrence Rate Between Mini-Slet (Simple Limbal Epithelial Transplantation) Versus Limbal-Conjunctival Autograft Techniques in Primary Pterygium Excision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Recurrence rate
研究概览
简要总结
The surgical treatment options for pterygium, an abnormal growth on the eye's frontal surface can be treated with several surgical techniques. The rates of pterygium coming back varies depending on the surgical technique employed and other factors related to the patient and surgery. The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.
详细描述
The surgical treatment options for pterygium, an abnormal growth on the eye's surface, encompass various approaches. These include standard surgical excision, which involves removing the pterygium using traditional surgical methods and more recently Simple Limbal Epithelial Transplantation. Recurrence rate of pterygium varies depending on the surgical technique employed and other factors related to the patient and surgery.The objective of this study is to assess the efficacy and safety of incorporating a single amniotic membrane with stem cells in the treatment of primary pterygium, aiming to enhance surgical outcomes and minimize recurrence rates.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The allocation of the study participants will be concealed in opaque envelopes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary nasal pterygium > 2mm
- •Patients who can present and continue follow-up for the duration of the study
- •Acceptance to participate in the study by signing the informed consent.
排除标准
- •Patients with rheumatoid arthritis
- •Collagenopathy
- •Infection, conjunctival inflammation or ocular trauma
- •Previous ocular surgery
结局指标
主要结局
Recurrence rate
时间窗: 1 month, 3, months, 6 months and 12 months after surgery.
Any fibrovascular growth that passes onto the cornea across the limbus, will be considered a recurrence.
次要结局
- Postoperative symptoms(1 month, 3, months, 6 months and 12 months after surgery.)
研究者
Enrique Graue
Head of the Cornea and Refractive Surgery Department
Instituto de Oftalmología Fundación Conde de Valenciana