NCT01284543Unknown不适用
Randomized Prospective Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in Descemet Stripping Automated Endothelial Keratoplasty (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
- Endothelial cell counts at 1, 3, 6 and 12 months postoperatively
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 Busin glide.
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
Endothelial cell counts at 1, 3, 6 and 12 months postoperatively
时间窗: 1 year
Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively
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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