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

NCT05694247 | Terminated DMC

• 1 other identifier: DMS-35932
• Study Type: interventional
• Target: 15
• Locations: 4 countries
• Sites: 6

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

Conditions

Corneal Disease; Corneal Opacity; Corneal Injuries

Outcome Measures

Primary Outcomes (1)

• Safety Assessment

  The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation

  Throughout 24 months post-op

Secondary Outcomes (2)

• Retention rate

  24 months post-op

• Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline

  Throughout 24 months post-op

Study Arms (1)

CorNeat KPro

EXPERIMENTAL

Intraocular implantation of the CorNeat KPro

Device: CorNeat KPro

Interventions

CorNeat KPro DEVICE

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.

CorNeat KPro

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥ 21 and ≤ 80 years on the day of screening
• Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
• 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
• Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation.
• 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;
• Adequate tear film and lid function
• Perception of light in all quadrants
• Female patients of childbearing age must have negative pregnancy test at screening and agree to use an effective method of contraception throughout the study.

You may not qualify if:

• Reasonable chance of success with traditional keratoplasty
• Current retinal detachment
• Connective tissue diseases or severely scarred conjunctiva in the target eye
• End stage glaucoma or evidence of current uncontrolled glaucoma
• History or evidence of severe inflammatory eye diseases (i.e. conjunctivitis, uveitis, retinitis, scleritis)
• Active inflammation of the conjunctiva in one or both eyes
• History of ocular or periocular malignancy
• History of extensive keloid formation
• Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the device
• Ocular ischemic syndrome
• Signs of current infection, including fever and current treatment with antibiotics
• Severe generalized disease that results in a life expectancy shorter than two years
• Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
• 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
• Currently pregnant or breastfeeding

Sponsors & Collaborators

• CorNeat Vision Ltd.: lead

Study Sites (6)

University of British Columbia

Vancouver, British Columbia, V5Z 3N9, Canada

Location

UHN - University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

CHU de Montpellier

Montpellier, 34295, France

Location

Hopital Fondation Adolphe de Rothschild

Paris, France

Location

Rabin Medical Center - Beilinson

Petah Tikva, Israel, 4941492, Israel

Location

Amsterdam UMC - Location AMC

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Corneal Diseases; Corneal Opacity; Corneal Injuries

Condition Hierarchy (Ancestors)

Eye Diseases; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: June 27, 2024
• Primary Completion: May 4, 2026
• Study Completion: May 4, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-03

Locations

CA (2); IL (1); FR (2); NL (1)