Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in best spectacle-corrected visual acuity
研究概览
简要总结
The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
详细描述
Keratoconus is a common corneal disease characterized by progressive thinning and steepening resulting in significant visual impairment. With improved instrumentation and corneal imaging technology, deep anterior keratoplasty has been recognized as the preferred primary operative technique for cases of keratoconus requiring corneal transplantation.
Since corneas preserved through organ culture remain viable only for up to 4 weeks, techniques that can extend storage of corneas have been explored.
The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Surgical candidates for deep anterior lamellar keratoplasty
排除标准
- •Ocular comorbidities other than cataract (ie. visual significant optic nerve or macular disease)
- •Previous corneal transplantations or other ocular surgeries except uncomplicated cataract surgery
- •Inability to comply with study protocol or participate in follow-up visits
结局指标
主要结局
Change in best spectacle-corrected visual acuity
时间窗: Preoperatively; and 6 and 12 months postoperatively
Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart
次要结局
- Change in astigmatism(Preoperatively; and 6 and 12 months postoperatively)
- Change in Thinnest-point pachymetry(Preoperatively; and 6 and 12 months postoperatively)
- Change in endothelial cell density(Preoperatively; and 6 and 12 months postoperatively)
- Incidence of graft rejection(6 and 12 months postoperatively)
- Incidence of graft failure(6 and 12 months postoperatively)
- Corneal donor loss due to preparation(Intraoperative)