The Effect of Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation on Treating Recurrent Pterygium: A Non-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes of grade of conjunctival hyperplasia
研究概览
简要总结
To observe the effect of micro-conjunctival autografting combined with amniotic membrane transplantation on the postoperative recurrence, complications and ocular surface symptoms among patients with recurrent pterygium.
详细描述
Recurrent pterygium is a common postoperative complication of pterygium surgery, the postoperative recurrence rate is about 1.44% and needs careful treatment. At present, surgical is the main and most effective treatment of recurrent pterygium. Among various surgical methods, autologous conjunctival transplantation is regarded as the first choice in normal conditions. However, the scope of conjunctival transplantation is positively correlated with the degree of ocular surface damage. Therefore, our research aimed to use micro conjunctival transplantation（1.5mm×3.0mm） to reconstruct limbal conjunctiva and amniotic membrane to cover the whole pterygium resection area to better protect conjunctival sac and ocular surface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •relapsed after pterygium surgery once;
- •invading the cornea 2.00~5.00mm.
排除标准
- •having obvious severe systemic organic diseases and mental diseases;
- •In lactation or pregnancy or planned pregnancy;
- •combined with eye diseases such as severe eyelid insufficiency, dry eye, chemical injury of cornea and conjunctiva, etc.;
- •used drugs that may affect the growth and metabolism of corneal epithelium within four weeks before inclusion in the study;
- •received pterygium surgery twice or more.
研究组 & 干预措施
experimental group
The experimental group received micro-conjunctival autograft combined with amniotic membrane transplantation.
干预措施: Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation (Procedure)
control group
The control group received given routine autologous conjunctival transplantation.
干预措施: Conventional Autologous Conjunctival Transplantation (Procedure)
结局指标
主要结局
Changes of grade of conjunctival hyperplasia
时间窗: Day 0#3#7 and14, Month 1#3 and 6.
Grade 1, no significant difference from normal eyes (no recurrence); Grade 2, a little episcleral vessels in the pterygium excision area, which extends to the corneoscleral limbus but does not exceed, and there is no fibrous tissue hyperplasia (no recurrence); Grade 3, having proliferative fibrous tissue in the resection area, which does not exceed the limbus (no recurrence); Grade 4, the cornea is invaded by proliferative fibrous tissue, and this grade is true pterygium recurrence (recurrence).
Changes of Schirmer test I
时间窗: Day 0#3#7 and14, Month 1#3 and 6.
5-minute Schirmer test I
Changes of ocular surface symptom scores
时间窗: Day 0#3#7 and14, Month 1#3 and 6.
Include dryness, burning, foreign body and pain sensation. The full score of each symptom is 100 points, with a score of 0 reflecting no discomfort, 100 was considered as the maximum discomfort.
次要结局
- Changes of corneal epithelial repair time(Day 0#3#7 and14, Month 1#3 and 6.)
- Changes of visual acuity(Day 0#3#7 and14, Month 1#3 and 6.)
研究者
Yifeng Yu
Associate professor
Second Affiliated Hospital of Nanchang University