Safety and Efficacy of Simple Non-cultured Endothelial Cell Injection(SNEC-I) Therapy for Corneal Endothelial Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- BSCVA
研究概览
简要总结
Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction
详细描述
The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving cell injection therapy generated from non-cultured human corneal endothelial cells. Clinical assessments include postoperative visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography (ASOCT), contrast sensitivity, as well as any postoperative complications such as graft dislocation or primary graft failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from irreversible post-surgical corneal decompensation, specifically, all forms of pseudophakic or aphakic bullous keratopathy.
排除标准
- •Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I.
- •Patients with complex anterior segment complications precluding a successful SNEC-I procedure
- •Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation
- •Post-laser iridotomy or glaucoma related corneal decompensation
- •Patients not keen to participate in the clinical trial
- •Patients who are below 21 years of age or above 80 years of age
- •Patients who are pregnant
- •Patients who are cognitively impaired
- •Patients who are prisoners
- •Patients with antibiotics/antimycotics allergies
结局指标
主要结局
BSCVA
时间窗: 1, 3, 6, 12 months post-operatively
Snellen best spectacle-corrected visual acuity (BSCVA). The Snellen BSCVA will be converted to logarithm of the minimum angle of resolution visual acuity for statistical analysis.
次要结局
- Autokeratorefractometer(1, 3, 6, and 12 months post-operatively)
- Intraocular pressure(1, 3, 6 and 12 months post-operatively)
- Endothelial Cell Density(1, 3, 6 and 12 months post-operatively)
- Graft thickness(1, 3, 6 and 12 months post-operatively)
- Contrast Sensitivity(6, 12 months post-operatively)