Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Pain questionnaire
研究概览
简要总结
To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and in patients without visual prediction.
The automated lamellar keratectomy represents a alternative in treatment of pain in symptomatic patients with BK.
详细描述
Only patients with BK symptomatic (with pain) were submitted to automated lamellar keratectomy (ALK).
Complete ophthalmological examination including UCVA,BSVA, biomicroscopy, tonometry, esthesiometry, UBM pachymetry, impression cytology and pain questionnaire were performed in preoperative, postoperative of one, seven, 30, 90, 180 days and one year.
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 (Participant)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with bullous keratopathy symptomatic (with pain)
排除标准
- •herpetic endotelial disorders
研究组 & 干预措施
1
Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy).
干预措施: Mitomycin (Drug)
2
automated lamellar keratectomy without mitomycin
干预措施: ALK (automated lamellar keratectomy) (Procedure)
结局指标
主要结局
Pain questionnaire
时间窗: preoperative and postoperative 1,7,30,90,180 days and one year
次要结局
- biomicroscopy, esthesiometry, UBM pachymetry, impression cytology(preoperative, postoperative 1,7,30,90,180 days and one year)