Adjunctive Use of Topical Cyclosporin A Versus Mitomycin C to Prevent Pterygium Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- recurrence rate of pterygium
研究概览
简要总结
aimed to compare the efficacy and safety of topical cyclosporin A (CsA) versus mitomycin C (MMC) as adjunctive therapies in preventing pterygium recurrence after surgical excision.
详细描述
A total of 40 eyes from 40 patients undergoing pterygium surgery were randomized into two groups: Group A received topical cyclosporin A, while Group B was treated with topical mitomycin C. Ocular surface inflammation scores, recurrence rates, patient-reported symptoms, and adverse effects were assessed at baseline and during follow-up at 6 months postoperatively.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Diagnosed with primary pterygium extending at least 1 mm onto the cornea.
- •No prior history of pterygium surgery in the affected eye.
排除标准
- •History of ocular surface diseases such as dry eye or Sjögren's syndrome.
- •Active ocular infection.
- •Known hypersensitivity to CsA or MMC.
- •Systemic conditions requiring immunosuppressive therapy.
研究组 & 干预措施
Group A (CsA Group)
Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.
干预措施: Excision of the pterygium (Procedure)
Group A (CsA Group)
Patients received topical cyclosporin A (0.05%) twice daily for three months postoperatively.
干预措施: Post-operative application of CsA (Drug)
Group B (MMC Group)
Patients received a single intraoperative application of mitomycin C (0.02%) for two minutes during surgery
干预措施: Excision of the pterygium (Procedure)
Group B (MMC Group)
Patients received a single intraoperative application of mitomycin C (0.02%) for two minutes during surgery
干预措施: Intra-operative application of MMC (Drug)
结局指标
主要结局
recurrence rate of pterygium
时间窗: 6 months after surgery
the recurrence rate of pterygium, defined as fibrovascular regrowth over the cornea of at least 1 mm
次要结局
- Change in parameter OSDI (ocular surface disease index) from 0 to 100 points.(6 months after surgery)
- Change in clinical parameter Schirmer test (from 0 to 15 mm)(6 months after surgery)
- Change in clinical parameter (TBUT)(6 months after surgery)
研究者
Ehab Mohamed Elsayed Mohamed Saad
Lecturer
Benha University