The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    corneat
Previous Study | Return to List | Next Study

Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05694247
Recruitment Status : Recruiting
First Posted : January 23, 2023
Last Update Posted : March 1, 2024
Sponsor:
Information provided by (Responsible Party):
CorNeat Vision Ltd.

Tracking Information
First Submitted Date  ICMJE January 12, 2023
First Posted Date  ICMJE January 23, 2023
Last Update Posted Date March 1, 2024
Estimated Study Start Date  ICMJE March 2024
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2023)		 Safety Assessment [ Time Frame: Throughout 24 months post-op ]
The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2023)
  • Retention rate [ Time Frame: 24 months post-op ]
    The number of retained devices at the end of 24- months follow up period will be calculated
  • Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline [ Time Frame: Throughout 24 months post-op ]
    Visual acuity will be measured with ETDRS format charts. The number of patients with BCDVA better than 6/120 at 24 months after
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness
Official Title  ICMJE A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
Brief Summary A Single Arm, Pivotal, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
Detailed Description

This clinical trial will assess the clinical safety and performance of the CorNeat Keratoprosthesis (KPro), a synthetic, artificial cornea for or the treatment of corneal blindness in subjects who are not candidates for traditional corneal transplant.

40 subjects who are willing to take part in the study will undergo screening examinations to verify their eligibility.

The CorNeat KPro will be implanted unilaterally in eligible subjects. Follow up procedures will be performed at 1 day, 1 week, 2 weeks, 1, 2, 3, 4, 5, 6,8, 10,12,15,18,21 and 24 months post-surgery and will include clinical assessment of the implanted eye using slit-lamp biomicroscopy, intra ocular pressure measurement and ocular imaging. Additionally, subjects' visual acuity will be assessed and recorded throughout the 24 months follow up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Corneal Disease
  • Corneal Opacity
  • Corneal Injuries
Intervention  ICMJE Device: CorNeat KPro
The optical component of the CorNeat KPro will be implanted into a circular disc of the cornea (as performed in standard penetrating keratoplasty surgery) and the skirt component will be embedded under a 360º conjunctival flap.
Study Arms  ICMJE Experimental: CorNeat KPro
Intraocular implantation of the CorNeat KPro
Intervention: Device: CorNeat KPro
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2023)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2026
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female aged ≥ 21 and ≤ 80 years on the day of screening
  2. Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
  3. Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In case of unilateral blindness - BCVA of Counting Fingers (CF) from 1 meter or worse in the operated eye
  4. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation.
  5. Indications that fall under poor candidate for keratoplasty include but are not limited to: herpetic keratitis, vascularized corneal scar, Ocular Cicatricial Pemphigoid, alkali burn, Steven Johnson Syndrome, and limbal stem cell deficiency;
  6. Adequate tear film and lid function
  7. Perception of light in all quadrants
  8. Female patients of childbearing age must have negative pregnancy test at screening and agree to use an effective method of contraception throughout the study.

Exclusion Criteria:

  1. Reasonable chance of success with traditional keratoplasty
  2. Current retinal detachment
  3. Connective tissue diseases or severely scarred conjunctiva in the target eye
  4. End stage glaucoma or evidence of current uncontrolled glaucoma
  5. History or evidence of severe inflammatory eye diseases (i.e. conjunctivitis, uveitis, retinitis, scleritis)
  6. Active inflammation of the conjunctiva in one or both eyes
  7. History of ocular or periocular malignancy
  8. History of extensive keloid formation
  9. Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the device
  10. Ocular ischemic syndrome
  11. Signs of current infection, including fever and current treatment with antibiotics
  12. Severe generalized disease that results in a life expectancy shorter than two years
  13. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
  14. Corneal thickness less than 400 or higher than 1,200 microns in any region of the pachymetry map of the eye intended to be operated
  15. Currently pregnant or breastfeeding
  16. 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
  17. Intraoperative complication that would preclude implantation of the study device
  18. Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes
  19. Patients requiring anticoagulation treatment, which cannot be interrupted for the surgical procedure
  20. Vulnerable populations - minors, pregnant women, prisoners, sponsor or study institution employees, military persons, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized patients and refugees
  21. Subjects with corneal disorders located outside the central 7 mm, such as Mooren ulcer, peripheral ulcerative keratitis, and necrotizing herpetic keratitis (if located outside the central 7 mm of the cornea)
  22. Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma Surgery (MIGS) device that shunts aqueous from the anterior chamber into the subconjunctival space
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ido Klein, B.Sc, MBA +972549350507 ido@corneat.com
Contact: Gilad Litvin, MD +972 50-351-4057 gilad@corneat.com
Listed Location Countries  ICMJE Canada,   France,   Israel,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05694247
Other Study ID Numbers  ICMJE DMS-35932
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party CorNeat Vision Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE CorNeat Vision Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CorNeat Vision Ltd.
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP