NCT05275972招募中3 期
Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 15
- 主要终点
- Best spectacle-corrected visual acuity (BSCVA)
研究概览
简要总结
Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.
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
- •Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
- •Peripheral endothelial cell count >1000 cells/mm2 in at least one quadrant
- •Good surgical candidate for either procedure as determined by the surgeon
- •Willingness to participate
- •Age greater than 18 years
排除标准
- •Aphakia, 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
- •Other primary endothelial dysfunction such as PPMD
- •Visually significant optic nerve or macular pathology
- •Hypotony (Intraocular pressure <10mmHg)
- •Any prior intraocular surgery other than cataract surgery
- •>3 clock hours of ANY anterior or posterior synechiae
- •>1 quadrant of stromal corneal vascularization
- •Inability to comply with post-operative instructions (i.e. unable to position)
- •Pregnancy
研究组 & 干预措施
DMEK plus topical placebo
Placebo Comparator
干预措施: Placebo (Drug)
DSO plus topical ripasudil 0.4%
Experimental
干预措施: Ripasudil (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 (BSCVA)
次要结局
- Endothelial cell density(3, 6, and 24 months)
- Best spectacle-corrected visual acuity (BSCVA)(3, 6 and 24 months)
研究者
Jennifer Rose-Nussbaumer
Professor
Stanford University
研究点 (15)
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