Eye Diseases Surgery
Conditions
Interventions
Sponsors
CorNeat Vision Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Conjunctival integrity at the implantation site will be 90% or more. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Kenya
Contacts
Public ContactGerry Tal
VP clinical affairs
Outcome results
None listed