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Trial record 2 of 2 for:    corneat

First-In-Man Study for an Ophthalmic Synthetic Tissue Substitute

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04037917
Recruitment Status : Active, not recruiting
First Posted : July 30, 2019
Last Update Posted : April 19, 2022
Information provided by (Responsible Party):
CorNeat Vision Ltd.

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

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).

Condition or disease Intervention/treatment Phase
Glaucoma Eye Tissue Breakdown Device: CorNeat EverPatch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 11, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Synthetic Tissue Substitute
Corneat EverPatch - Synthetic Tissue Substitute for Covering Ophthalmic Implants
Device: CorNeat EverPatch
Covering Ophthalmic Implants

Primary Outcome Measures :
  1. Number of treatment-related adverse events [ Time Frame: up to 12 months ]
    The frequency of all Unanticipated Adverse Device-related Events (UADE) or treatment-related adverse events

Secondary Outcome Measures :
  1. Conjunctival integrity [ Time Frame: up to 12 months ]
    Conjunctival integrity at the implantation should be 90% or more as measured by Slit lamp examination

  2. Stability in patch dimensions [ Time Frame: up to 12 months ]
    Stability in patch dimensions should show 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female
  2. Aged ≥ 18 and ≤ 80 years on screening day
  3. Concealment of an artificial ophthalmic implant or a glaucoma tube shunt is indicated.
  4. Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
  5. Adequate tear film and lid function
  6. Visual acuity of light perception or better
  7. 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:

  1. Current retinal detachment
  2. Active ocular or orbital infection
  3. 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
  4. History of ocular or periocular malignancy
  5. History of extensive keloid formation
  6. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or component of the device
  7. Signs of current infection, including fever and current treatment with antibiotics
  8. Severe generalized disease that results in a life expectancy shorter than a year
  9. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
  10. Currently pregnant or breastfeeding
  11. 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
  12. Intraoperative complication that would preclude implantation of the study device.
  13. Any traumatic perforation
  14. Tissue gaps/weaknesses, resulting either from traumatic, disease-related or iatrogenic damage
  15. Loss of scleral integrity where use of tissue or substitutes is indicated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04037917

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Canada, Ontario
Prism Eye Institute
Oakville, Ontario, Canada, L6H OJ8
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Hospital Foundation Adolphe De Rothschild
Paris, France
Kwale eye hospital
Mombasa, Kenya
Kenyatta National Hospital
Nairobi, Kenya
Lions SightFirst Hospital
Nairobi, Kenya
Sponsors and Collaborators
CorNeat Vision Ltd.
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Responsible Party: CorNeat Vision Ltd. Identifier: NCT04037917    
Other Study ID Numbers: SP-001
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases