Status:
TERMINATED
First-In-Man Study for an Ophthalmic Synthetic Tissue Substitute
Lead Sponsor:
CorNeat Vision Ltd.
Conditions:
Glaucoma Eye
Tissue Breakdown
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 Objecti...
Detailed Description
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 Objecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04037917
Start Date
December 11 2020
End Date
July 1 2023
Last Update
September 7 2023
Active Locations (6)
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1
Prism Eye Institute
Oakville, Ontario, Canada, L6H OJ8
2
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
3
Hospital Foundation Adolphe De Rothschild
Paris, France
4
Kwale eye hospital
Mombasa, Kenya