NCT03069521已完成不适用
Prospective, Feasibility Study to Evaluate the Safety of the EndoArt™ for Treatment of Subjects Suffering From Corneal Edema
Eye-yon Medical8 个研究点 分布在 4 个国家目标入组 22 人开始时间: 2017年6月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 8
- 主要终点
- Treatment-related adverse events
研究概览
简要总结
Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of 30 subjects suffering from corneal edema. Followed up for 12 months.
详细描述
Title: Prospective, feasibility study to evaluate the safety of the EndoArt® for treatment of subjects suffering from corneal edema
Device: EndoArt® (Artificial Endothelial Layer)
Intended Use: The EndoArt® device is intended for use as an endothelial kearatoprosthesis in patients with chronic cornel edema
Study Design: Prospective open-label feasibility clinical study
Study Objectives: To evaluate the safety of the EndoArt® implanted in subjects suffering from corneal edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is over 40 years old
- •Subject with chronic corneal edema.
- •Subject with corneal thickness >650 µm
- •Subject with visual acuity 6/30 or worse (equivalent ETDRS)
- •Subject with better visual acuity in the contralateral eye.
- •Pseudophakic subject (anterior or posterior) with stable IOL.
- •Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
排除标准
- •Subject with best corrected visual acuity of 6/30 or worse in the fellow eye
- •Subject with history of ocular Herpes keratitis
- •Subject with severely scarred cornea (unfit for regular endothelial keratoplasty)
- •Subject with irregular posterior cornea (e.g. post PKP)
- •Subject who is suffering from infection of the cornea
- •Patients with band keratopathy and/or limbal stem cell deficiency.
- •Subject with clinical moderate to severe dry eye
- •Subject with phthisis or phthisis suspect
- •Subject with low ocular pressure ≤6 mmHg or higher than 25 mmHg.
- •Subject with aphakica
- •Subject with pseudophakodonesis
- •Subject with large iris defect which can compromise intraoperative AC stability.
- •Subjects after corneal refractive surgery.
- •Subject with glaucoma shunt (e.g. Ahmend valve)
- •Subject with neurotrophic corneal history
- •Subject with history of persistent corneal erosion difficulties with epithelial growth (re-epithelization)
- •Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days
结局指标
主要结局
Treatment-related adverse events
时间窗: 6 months following EndoArt implantaion
frequency and severity of all treatment-related adverse events
次要结局
- Subjective corneal clarity(12 months following EndoArt implantaion)
- Pain as assessed by a Visual Analogue Scale (VAS)(12 months following EndoArt implantaion)
- Measurement Best Corrected Distance Visual Acuity (BCDVA)(12 months following EndoArt implantaion)
- Corneal thickness(12 months following EndoArt implantaion)
研究者
研究点 (8)
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