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.
- Conditions
- Eye DiseasesSurgery
- Registration Number
- PACTR202007844168087
- Lead Sponsor
- CorNeat Vision Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events, during and following implantation of the CorNeat EverPatch device, and follow-up for up to 12 months will be 10% or less.<br>;Conjunctival integrity at the implantation site will be 90% or more.
- Secondary Outcome Measures
Name Time Method Stability in patch dimensions, less than 10% change (length, projected width and thickness) measured by OCT after 1-week and follow-up for up to 12 months post-implantation in 90% of the implanted patients