Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty (TE-EK)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- (BSCVA)
研究概览
简要总结
Assessment of safety and efficacy of tissue-engineered corneal endothelial graft material generated using cultured human corneal endothelial cells for tissue-engineered endothelial keratoplasty (TE-EK).
详细描述
The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving Tissue-Engineered Endothelial keratoplasty (TE-EK) graft material generated from human corneal endothelial cells (HCEnCs) propagated in a regulatory-approved dual media approach. Post-operative follow-ups and visits will follow current EK protocols of Singapore National Eye Centre. 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
- 21 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 a variety of conditions including:
- •Fuchs' endothelial dystrophy
- •Post-surgical corneal decompensation (irreversible) - 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, unsuitable for TE-EK surgery as opposed to penetrating keratoplasty
- •Patients with complex anterior segment complications precluding a successful TE-EK 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 who are allergic to antibiotics
结局指标
主要结局
(BSCVA)
时间窗: 3 months
BSCVA will be converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis.
次要结局
- Keratometric astigmatism and spherical equivalent(3 months)
- Intraocular pressure measurement(3 Months)
- Endothelial cell density (ECD)(3 months)
- Graft thickness(1 month)
- Contrast sensitivity(6 months)
- Postoperative complications(1 month)
研究者
Jodhbir Mehta
Senior Consultant Head Corneal and External Eye Disease and Refractive Service
Singapore Eye Research Institute