NCT00409955已完成2 期
Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas
Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Topography
研究概览
简要总结
- The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas
详细描述
- After the development of a techinique to lyophilize corneas, we randomly assingned 20 patients with keratoconus and visual acuity of < 20/60, who signed the consent term and divided them into 2 groups. One group was transplanted with lyophilized corneas and the other group with optisol corneas.
- Patients are being followed for 6 months with visual acuity, refraction, topography, orbscan, pachmetry, ultrasound biomicroscopy and confocal microscopy.
- Results are going to be statistically analysed by SPSS program.
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
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
- •Keratoconus patient
- •BCVA < 20/60
- •No systemic diseases
- •Who signed the inform consent
排除标准
- •BCVA > 20/60
- •Presence of deep opacities
- •Systemic diseases
结局指标
主要结局
Topography
Orbscan
Pachmetry
Ultrasound Biomicroscopy
Confocal Microscopy
Masked Examiner to evaluate transparency and quality of the transplant
次要结局
未报告次要终点
研究者
研究点 (1)
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