DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery : Serious Complication Rate and Visual Efficacy at 12 Months
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Occurrence rate of at least one serious DMEK post-op complication
研究概览
简要总结
DMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat primary or secondary corneal endothelial decompensation. At the Rothschild Foundation, as in many Western referral centers, DMEK is currently the surgical technique of choice for the treatment of primary or secondary corneal endothelial decompensation.
Technically challenging, it is a relatively tedious surgery to learn, but offers the best visual and refractive results, as well as faster visual and functional recovery in simple cases.
In patients without anterior or posterior segment surgical history, the complication rate of DMEK, including graft rejection, is similar to that of other endothelial keratoplasty surgical techniques.
However, in specific cases, in patients with a history of ophthalmological surgery such as vitrectomy, trabeculectomy, large iris defects, anterior synechiae, aniridia or aphakia, the scientific literature shows a higher complication rate for DMEK (increased rate of rebulling and graft decompensation).
As a result, other techniques that are less effective on visual results continue to be used for these patients in a large number of centers.
Nonetheless, in our department, DMEK is also performed on these complicated patients.
When it comes to patients with a history of anterior or posterior segment surgery, it seems to us that the surgeons' experience with DMEK allows better visual results than with any other technique, but without any back up regarding the complication rate in the literature.
The main aim of this study is to describe, in patients with a history of anterior or posterior segment surgery undergoing DMEK, the 12-months occurrence rate of at least one serious post-operative complication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Occurrence rate of at least one serious DMEK post-op complication
时间窗: 12 months
Composite endpoint made of 4 serious post-op complications : * Rebulling : graft detachment of more than one-third of its surface area one week after surgery (on Avanti OCT-cornea), requiring air or gas injection in the anterior chamber. * Graft failure : no improvement in pachymetry at three months post-op (Avanti OCT-cornea). * Graft rejection : presence of cellular Tyndall in the anterior chamber and/or retro-descemetic precipitates and/or focal or diffuse increase in pachymetry \> 20μm (Avanti OCT-cornea and slit-lamp biomicroscopic examination). * Macular cystoid edema : presence of intraretinal fluid in the macular area (macular OCT).
次要结局
- Rebulling occurrence rate(12 months)
- Duration of surgical procedure (in minutes)(Right after the completion of the surgery)
- Macular cystoid edema occurrence rate(12 months)
- Graft failure occurrence rate(12 months)
- Graft rejection occurrence rate(12 months)
- Surgeon's subjective assessment of surgical complexity(Right after the completion of the surgery)
- Evolution of posterior keratometry(12 months after surgery)
- Graft detachment (with or without rebulling) occurrence rate(12 months)
- Evolution of refractive results(12 months after surgery)
- Evolution of corneal thickness(12 months after surgery)
- Evolution of visual results (corrected and uncorrected)(12 months after surgery)
- Evolution of endothelial loss(12 months after surgery)
- Intraocular hypertension occurrence rate(12 months)