Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 9
- 主要终点
- Best spectacle-corrected visual acuity (BSCVA)
研究概览
简要总结
Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea or severe edema without visualization of guttata
- •Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD)
- •Dysfunctional endothelium from prior graft failure after PKP or EK
- •Controlled uveitis (defined as quiet for > 3 months off of topical steroids with or without systemic immunosuppression) or no uveitis
- •Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP < 5 mmHg) or no glaucoma
- •Good candidate for corneal transplantation for either DMEK or UT-DSAEK
- •Willingness to participate
- •Age greater than 18 years
排除标准
- •Aphakia, or anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK
- •Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
- •Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
- •Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology
- •Pregnancy
研究组 & 干预措施
UT-DSAEK plus topical ripasudil
This arm will receive UT-DSAEK plus topical ripasudil 0.4%
干预措施: Topical Ripasudil (Drug)
DMEK plus topical ripasudil
This arm will receive DMEK plus topical ripasudil 0.4%
干预措施: Topical Ripasudil (Drug)
DMEK plus topical placebo
This arm will receive DMEK plus topical placebo
干预措施: Topical Placebo (Drug)
UT-DSAEK plus topical placebo
This arm will receive UT-DSAEK plus topical placebo
干预措施: Topical Placebo (Drug)
结局指标
主要结局
Best spectacle-corrected visual acuity (BSCVA)
时间窗: 12 months
Best spectacle-corrected visual acuity
Endothelial cell loss
时间窗: 12 months
Change between endothelial density at baseline versus density at 12 months
次要结局
- Best spectacle-corrected visual acuity (BSCVA)(3, 6 and 24 months)
研究者
Jennifer Rose-Nussbaumer
Professor
Stanford University