Deep Lamellar Endothelial Keratoplasty as Surgical Treatment for Corneal Endothelial Decompensation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Visual acuity.
研究概览
简要总结
The objectives of this study are to compare the visual and refractive outcomes of deep lamellar endothelial keratoplasty (DLEK) with penetrating keratoplasty as treatment for certain cases of corneal edema due to endothelial decompensation. Additionally, data will be collected to compare corneal shape, corneal thickness, endothelial cell density, keratocyte density, corneal sensitivity, light scatter, and subjective visual function between the two procedures.
详细描述
This will be a randomized prospective study. We will enroll patients using the following inclusion and exclusion criteria, based upon the surgeon?s initial complete ophthalmic examination, which includes refraction, keratometry, slit lamp examination, intraocular pressure and corneal thickness measurement, and dilated fundus examination.
Inclusion criteria:
- Both males and females are eligible 2) Patient age 21 years or older 3) Corneal edema due to endothelial dysfunction 4) Aphakia, pseudophakia, or cataract requiring extraction 5) Visual acuity as measured in standardized fashion (ETDRS chart and appropriate illumination)
- Study eye; best spectacle-corrected entrance acuity 20/40 or worse
- Contralateral eye; best spectacle-corrected entrance acuity equal to or better than the study eye and 20/200 or better.
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Visual acuity.
次要结局
- Astigmatism
- contrast sensitivity
- corneal haze
- endothelial cell density
- corneal thickness