The CorNeat EverPatch is a First-In-Human clinical study aimed at demonstrating the safety of a synthetic tissue substitute for covering a glaucoma tube shunt.

CorNeat Vision Ltd0 个研究点目标入组 15 人开始时间: 2020年7月5日最近更新: 2023年5月29日

适应症

试验速览

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•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.

•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

发起方