Prospective, Open Label, Single Arm, First in Human (FIH) Clinical Study to Assess Safety and Efficacy of the CorNeat Keratoprosthesis for the Treatment of Corneal Blindness
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 14
- 主要终点
- Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE)
研究概览
简要总结
Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal blindness
详细描述
The objective of this clinical study is to prove the safety and effectiveness of the CorNeat Keratoprosthesis (KPro), a synthetic, artificial cornea for or the treatment of corneal blindness in subjects who are not candidates for traditional corneal transplant.
Ten subjects who are willing to take part in the study will undergo screening examinations to verify their eligibility.
The CorNeat KPro will be implanted unilaterally in eligible subjects. Follow up procedures will be performed at 1 day, 1 week, 1, 2, 3, 6, 9 & 12 months post implantation and will include clinical assessment of the implanted eye using slit-lamp biomicroscopy, intra ocular pressure measurement and ocular imaging. Additionally, subjects' visual acuity will be assessed and recorded throughout the 12 months follow up period.
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
- •Male or female aged ≥ 18 and ≤ 80 years on the day of screening
- •Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
- •Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation
- •Indications that fall under poor candidate for keratoplasty include but are not limited to: herpetic keratitis, vascularized corneal scar, Ocular Cicatricial Pemphigoid, alkali burn, Steven Johnson Syndrome, and limbal stem cell deficiency
- •Pseudophakia
- •Adequate tear film and lid function
- •Perception of light in all quadrants
- •Female patients of childbearing age must have negative pregnancy test at screening and agree to use an effective method of contraception throughout the study
排除标准
- •Reasonable chance of success with traditional keratoplasty
- •Current retinal detachment
- •Connective tissue diseases
- •End-stage glaucoma
- •History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to planned implantation
- •History of ocular or periocular malignancy
- •History of extensive keloid formation
- •Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the device
- •Signs of current infection, including fever and current treatment with antibiotics
- •Severe generalized disease that results in a life expectancy shorter than a year
- •Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
- •Corneal thickness less than 400 or higher than 1,200 microns in any region of the pachymetry map of the eye intended to be operated
- •Currently pregnant or breastfeeding
- •Participation in any study involving an investigational drug or device within the past 30 days or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device
- •Intraoperative complication that would preclude implantation of the study device
- •Vulnerable populations
结局指标
主要结局
Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE)
时间窗: Throughout the 12 months follow up period
The frequency and severity of all unanticipated adverse device-related events (UADE) or treatment-related adverse events, during and after implantation of the CorNeat KPro and up to 12 months should be less than SOC
次要结局
- Secondary Effectiveness Endpoint - Improvement in BCDVA(Throughout the 12-months post operation)