An interventional study of CorNeat KPro in Corneal Disease, Corneal Opacity and Corneal Injuries, sponsored by CorNeat Vision Ltd.. Terminated at 8 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by CorNeat Vision Ltd. · Not applicable, Interventional, and Treatment
Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal blindness
The objective of this clinical study is to prove the safety and effectiveness 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.
Ten 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, 1, 2, 3, 6, 9 \& 12 months post implantation 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 12 months follow up period.
219 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 132 interventional studies indexed under Corneal Diseases.
Browse Corneal Diseases studies →CorNeat Vision Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intraocular implantation of the CorNeat KPro
Device: CorNeat KPro
CorNeat KPro will be implanted into the subject's eye where the optic component snaps into the patient's trephined cornea and is sutured to the eye wall using 3 non-degradable sutures and the skirt component is placed under the conjunctiva
Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE)
The frequency and severity of all unanticipated adverse device-related events (UADE) or treatment-related adverse events, during and after implantation of the CorNeat KPro and up to 12 months should be less than SOC
Time frame: Throughout the 12 months follow up period
Secondary Effectiveness Endpoint - Improvement in BCDVA
Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline
Time frame: Throughout the 12-months post operation
| Milestone | CorNeat KPro |
|---|---|
| Started | 10 |
| Implantations in israel, france, canada | 10 |
| Improved visual acuity at some point throughout the study | 8 |
| Va improvement at their last follow up visit they attended (after 6-24 months from surgery) | 4 |
| Completed | 5 |
| Not completed | 5 |
The frequency and severity of all unanticipated adverse device-related events (UADE) or treatment-related adverse events, during and after implantation of the CorNeat KPro and up to 12 months should be less than SOC
| Participants | CorNeat KPro |
|---|---|
| Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE) | 7 |
Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline
| Participants | CorNeat KPro |
|---|---|
| Secondary Effectiveness Endpoint - Improvement in BCDVA | 8 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CorNeat KPro | 0/10 (0%) | 7/10 (70%) | 7/10 (70%) |
| Event | CorNeat KPro |
|---|---|
| Covid 19 InfectionInfections and infestations | 1/10 |
| Exposure of implantEye disorders | 1/10 |
| Flat AC with bleedingEye disorders | 1/10 |
| Fungal infection in the skirt of artificial corneaEye disorders | 1/10 |
| HeadacheGeneral disorders | 1/10 |
| Shallow retinal detachmentEye disorders | 1/10 |
| Dehiscence of prosthesis superiorlyEye disorders | 1/10 |
| Conjunctival retraction with dehiscence of prosthesis & possible corneal epithelial ingrowthEye disorders | 1/10 |
| Choroidal detachment and exudative detachmentEye disorders | 1/10 |
| Event | CorNeat KPro |
|---|---|
| Exposed synthetic skirt of the implantEye disorders | 3/10 |
| Severe headache (crown top right)General disorders | 2/10 |
| Choroidal HemorrhageEye disorders | 2/10 |
| Vitreous HemorrhageEye disorders | 2/10 |
| Metabolic acidosisEye disorders | 1/10 |
| Retro prosthetic membraneEye disorders | 1/10 |
| White nodule on the prosthetic skirtEye disorders | 1/10 |
| left eye ocular painEye disorders | 1/10 |
| fungal infection in the skirt of cornet artificial corneaEye disorders | 1/10 |
| abnormal serum enzyme levelsEye disorders | 1/10 |
| Age, Continuous(Years) | CorNeat KPro |
|---|---|
| Mean | 64.6 (38 to 78) |
| Sex: Female, Male(Participants) | CorNeat KPro |
|---|---|
| Female | 1 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | CorNeat KPro |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | CorNeat KPro |
|---|---|
| Canada | 5 |
| Israel | 3 |
| France | 2 |
| Slit lamp examinations(participants) | CorNeat KPro |
|---|---|
| Normal Lids/Lashes/Lacrimal | 5 |
| Trichiasis Lids/Lashes/Lacrimal | 2 |
| Tarsorrhaphy Lids/Lashes/Lacrimal | 2 |
| Ptosis Lids/Lashes/Lacrimal | 1 |
| Normal conjunctiva | 10 |
| Mild cornea edema | 1 |
| Moderate cornea edema | 5 |
| Severe cornea edema | 4 |
| AC deep | 8 |
| AC medium | 1 |
| No flare | 5 |
| No Fibrin present | 7 |
| No cells present | 5 |
| Normal iris | 5 |
| Anirdia iris | 1 |
| Morcher, iris prosthetic | 1 |
| Normal pupil | 7 |
| Normal vitreous body | 4 |
| Pale optic nerve | 1 |
| Normal macula | 1 |
| Normal retinal vessels | 2 |
| Normal retinal periphery | 2 |
| Ocular imaging(Participants) | CorNeat KPro |
|---|---|
| Pachymetry | 7 |
| AC depth | 3 |
| AC Morphology | 6 |
| Location and position of IOL | 5 |
| Angle Morphology | 7 |
| Pain assessment(participants) | CorNeat KPro |
|---|---|
| No or minimal pain (grades 0-2) | 8 |
| Mild pain (grades 3-4) | 1 |
| Moderate pain (grades 5-7) | 1 |
| Severe pain (grades 8-10) | 0 |
Plan to share: Undecided
Ran from Jan 2021 to primary completion in Jun 2023, 28 months.
Results were first posted in Sep 2024, 1 year 3 months after primary completion.
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This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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CorNeat Vision Ltd.