The CorNeat EverPatch - a First-In-Man Clinical Study for Demonstrating the Safety of a Synthetic Tissue Substitute for Concealment of Artificial Implants and Glaucoma Tube Shunts
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 8
- 主要终点
- Number of treatment-related adverse events
研究概览
简要总结
Study Name: The CorNeat EverPatch - a First-In-Man Clinical Study for demonstrating the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts
Objective: The objective of this clinical trial is to demonstrate the Safety of the Corneat Everpatch for concealment of artificial implants and glaucoma tube shunts
The study will consist 10 subjects requiring concealment of a glaucoma shunt or other ophthalmic implant. Eligible subjects who signs an ICF will be enrolled to the study. Subjects will be implanted with the Corneart EverPatch as part of a glaucoma shunt surgery or during a corrective surgery to repair a breached conjunctiva over an implanted device. Subjects will be monitored for a period of 12 months post-op during which follow up visits will occur at 1 week, 1, 2, 3, 6, 9 & 12 months following surgery including clinical examination of the operated eye using slit-lamp biomicroscopy and imaging using OCT or UBM (will be performed only at the 6 & 12 months follow up visits).
详细描述
Study Name: The CorNeat EverPatch - a First-In-Man Clinical Study for demonstrating the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts
Objective: The objective of this clinical trial is to demonstrate the Safety of the Corneat Everpatch for concealment of artificial implants and glaucoma tube shunts
Study endpoints:
Primary Safety Endpoint:
The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events, during and following implantation and follow-up for up to 12 months will be 10% or less.
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 screening day
- •Concealment of an artificial ophthalmic implant or a glaucoma tube shunt is indicated.
- •Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
- •Adequate tear film and lid function
- •Visual acuity of light perception or better
- •Female patients of childbearing age must agree to use a method of contraception and have negative pregnancy test at screening. An effective method of contraception must be used throughout the study.
排除标准
- •Current retinal detachment
- •Active ocular or orbital infection
- •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 anesthetics, 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
- •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.
- •Any traumatic perforation
- •Tissue gaps/weaknesses, resulting either from traumatic, disease-related or iatrogenic damage
- •Loss of scleral integrity where use of tissue or substitutes is indicated.
结局指标
主要结局
Number of treatment-related adverse events
时间窗: up to 12 months
The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events
次要结局
- Stability in patch dimensions(up to 12 months)
- Conjunctival integrity(up to 12 months)