Corneal DiseaseNCT05694247
Study to Evaluate the Clinical Safety and Performance of the CorNeat KPro for Treatment of Corneal Blindness
A study testing CorNeat KPro in people with Corneal Disease and Corneal Opacity, run by CorNeat Vision Ltd. at 6 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Corneal Disease, Corneal Opacity, Corneal Injuries
- What is being tested?
- CorNeat KPro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 27 Jun 2024to 4 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
- 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
- Hemoglobin A1C (HbA1c) higher than 8% at screening indicating unbalanced diabetes and/or target organ damage associated with diabetes
- Patients requiring anticoagulation treatment, which cannot be interrupted for the surgical procedure
- 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
- 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)
- Patients with a functioning trabeculectomy or existing Microinvasive Glaucoma Surgery (MIGS) device that shunts aqueous from the anterior chamber into the subconjunctival space
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Canada2 sites
UHN - University Health Network
Toronto, Ontario, M5T 2S8
University of British Columbia
Vancouver, British Columbia, V5Z 3N9
France2 sites
CHU de Montpellier
Montpellier, 34295
Hopital Fondation Adolphe de Rothschild
Paris
About this study
Official title: A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
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
Read the 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.
- Conditions
- Corneal Disease, Corneal Opacity, Corneal Injuries
- Being tested
- CorNeat KPro
- Medical subject headings
- Corneal Diseases, Corneal Opacity, Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorNeat KProDevice
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 group | Role | What they receive |
|---|---|---|
| CorNeat KPro | Experimental | Intraocular implantation of the CorNeat KPro Receives: Device: CorNeat KPro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation
Measured: Throughout 24 months post-op
Secondary outcomes (2)
Retention rate
The number of retained devices at the end of 24- months follow up period will be calculated
Measured: 24 months post-op
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline
Visual acuity will be measured with ETDRS format charts. The number of patients with BCDVA better than 6/120 at 24 months after
Measured: Throughout 24 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start27 Jun 2024
- Primary completion4 May 2026
- Study completion4 May 2026
Why it stopped: The study was voluntarily terminated by the sponsor following emerging safety findings, including device exposure associated with conjunctival retraction. Enrollment was halted to allow further evaluation and optimization of the device and procedure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- CorNeat Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694247
- Sponsor's protocol ID
- DMS-35932
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness
- ClinicalTrials.gov ID
- NCT05694247
- Acronym / sponsor ID
- DMS-35932
- Conditions
- Corneal Disease, Corneal Opacity, Corneal Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was voluntarily terminated by the sponsor following emerging safety findings, including device exposure associated with conjunctival retraction. Enrollment was halted to allow further evaluation and optimization of the device and procedure.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- CorNeat Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CorNeat KPro | Experimental | Device: CorNeat KProIntraocular implantation of the CorNeat KPro |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorNeat KProThe 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. | Device | CorNeat KPro |
Primary outcome
Safety Assessment
Time frame: Throughout 24 months post-op
The frequency of all Unanticipated Adverse Device-related Events (UADE) during and following implantation
2 secondary outcomes
Retention rate
Time frame: 24 months post-op
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline
Time frame: Throughout 24 months post-op
Results and safety
The study was stopped early (reason given: The study was voluntarily terminated by the sponsor following emerging safety findings, including device exposure associated with conjunctival retraction. Enrollment was halted to allow further evaluation and optimization of the device and procedure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CorNeat KPro in people with Corneal Disease and Corneal Opacity, run by CorNeat Vision Ltd. at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, France, Israel, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was voluntarily terminated by the sponsor following emerging safety findings, including device exposure associated with conjunctival retraction. Enrollment was halted to allow further evaluation and optimization of the device and procedure.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (time frame: Throughout 24 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.