NCT01284101Unknown不适用
Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Donor Graft Endothelial cell counts
研究概览
简要总结
The Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Forceps.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation.
- •Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma.
- •Ability to understand the nature of the procedure and give full informed consent.
- •Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital.
排除标准
- •Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty.
- •Patients with complex anterior segment pathology precluding successful DSAEK procedure.
- •Patients not giving full informed consent to participate in the trial
结局指标
主要结局
Donor Graft Endothelial cell counts
时间窗: 1 year
Best corrected visual acuity
时间窗: 1 year
次要结局
- Complications of surgery(1 year)
研究者
研究点 (2)
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