Trial Outcomes & Findings for First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness (NCT NCT04485858)
NCT ID: NCT04485858
Last Updated: 2024-09-24
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Throughout the 12 months follow up period
Results posted on
2024-09-24
Participant Flow
Participant milestones
| Measure |
CorNeat KPro
Intraocular implantation of the CorNeat KPro
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
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
Implantations in Israel, France, Canada
|
10
|
|
Overall Study
Improved Visual Acuity at Some Point Throughout the Study
|
8
|
|
Overall Study
VA Improvement at Their Last Follow up Visit They Attended (After 6-24 Months From Surgery)
|
4
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness
Baseline characteristics by cohort
| Measure |
CorNeat KPro
n=10 Participants
Intraocular implantation of the CorNeat KPro
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
|
|---|---|
|
Age, Continuous
|
64.6 Years
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=93 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=93 Participants
|
|
Region of Enrollment
France
|
2 participants
n=93 Participants
|
|
Slit lamp examinations
Normal Lids/Lashes/Lacrimal
|
5 participants
n=93 Participants
|
|
Slit lamp examinations
Trichiasis Lids/Lashes/Lacrimal
|
2 participants
n=93 Participants
|
|
Slit lamp examinations
Tarsorrhaphy Lids/Lashes/Lacrimal
|
2 participants
n=93 Participants
|
|
Slit lamp examinations
Ptosis Lids/Lashes/Lacrimal
|
1 participants
n=93 Participants
|
|
Slit lamp examinations
Normal conjunctiva
|
10 participants
n=93 Participants
|
|
Slit lamp examinations
Mild cornea edema
|
1 participants
n=93 Participants
|
|
Slit lamp examinations
Moderate cornea edema
|
5 participants
n=93 Participants
|
|
Slit lamp examinations
Severe cornea edema
|
4 participants
n=93 Participants
|
|
Slit lamp examinations
AC deep
|
8 participants
n=93 Participants
|
|
Slit lamp examinations
AC medium
|
1 participants
n=93 Participants
|
|
Slit lamp examinations
No flare
|
5 participants
n=93 Participants
|
|
Slit lamp examinations
No Fibrin present
|
7 participants
n=93 Participants
|
|
Slit lamp examinations
No cells present
|
5 participants
n=93 Participants
|
|
Slit lamp examinations
Normal iris
|
5 participants
n=93 Participants
|
|
Slit lamp examinations
Anirdia iris
|
1 participants
n=93 Participants
|
|
Slit lamp examinations
Morcher, iris prosthetic
|
1 participants
n=93 Participants
|
|
Slit lamp examinations
Normal pupil
|
7 participants
n=93 Participants
|
|
Slit lamp examinations
Normal vitreous body
|
4 participants
n=93 Participants
|
|
Slit lamp examinations
Pale optic nerve
|
1 participants
n=93 Participants
|
|
Slit lamp examinations
Normal macula
|
1 participants
n=93 Participants
|
|
Slit lamp examinations
Normal retinal vessels
|
2 participants
n=93 Participants
|
|
Slit lamp examinations
Normal retinal periphery
|
2 participants
n=93 Participants
|
|
Ocular imaging
Pachymetry
|
7 Participants
n=93 Participants
|
|
Ocular imaging
AC depth
|
3 Participants
n=93 Participants
|
|
Ocular imaging
AC Morphology
|
6 Participants
n=93 Participants
|
|
Ocular imaging
Location and position of IOL
|
5 Participants
n=93 Participants
|
|
Ocular imaging
Angle Morphology
|
7 Participants
n=93 Participants
|
|
Pain assessment
No or minimal pain (grades 0-2)
|
8 participants
n=93 Participants
|
|
Pain assessment
Mild pain (grades 3-4)
|
1 participants
n=93 Participants
|
|
Pain assessment
Moderate pain (grades 5-7)
|
1 participants
n=93 Participants
|
|
Pain assessment
Severe pain (grades 8-10)
|
0 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Throughout the 12 months follow up periodThe 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
Outcome measures
| Measure |
CorNeat KPro
n=10 Participants
Intraocular implantation of the CorNeat KPro
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)
|
7 Participants
|
SECONDARY outcome
Timeframe: Throughout the 12-months post operationImprovement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline
Outcome measures
| Measure |
CorNeat KPro
n=10 Participants
Intraocular implantation of the CorNeat KPro
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
|
|---|---|
|
Secondary Effectiveness Endpoint - Improvement in BCDVA
|
8 Participants
|
Adverse Events
CorNeat KPro
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CorNeat KPro
n=10 participants at risk
Intraocular implantation of the CorNeat KPro
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
|
|---|---|
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Infections and infestations
Covid 19 Infection
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Exposure of implant
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Flat AC with bleeding
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Fungal infection in the skirt of artificial cornea
|
10.0%
1/10 • 2 years
|
|
General disorders
Headache
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Shallow retinal detachment
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Dehiscence of prosthesis superiorly
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Conjunctival retraction with dehiscence of prosthesis & possible corneal epithelial ingrowth
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Choroidal detachment and exudative detachment
|
10.0%
1/10 • 2 years
|
Other adverse events
| Measure |
CorNeat KPro
n=10 participants at risk
Intraocular implantation of the CorNeat KPro
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
|
|---|---|
|
Eye disorders
Metabolic acidosis
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Retro prosthetic membrane
|
10.0%
1/10 • Number of events 3 • 2 years
|
|
Eye disorders
Exposed synthetic skirt of the implant
|
30.0%
3/10 • 2 years
|
|
Eye disorders
White nodule on the prosthetic skirt
|
10.0%
1/10 • 2 years
|
|
Eye disorders
left eye ocular pain
|
10.0%
1/10 • 2 years
|
|
Eye disorders
fungal infection in the skirt of cornet artificial cornea
|
10.0%
1/10 • 2 years
|
|
Eye disorders
abnormal serum enzyme levels
|
10.0%
1/10 • 2 years
|
|
Eye disorders
elevated IOP
|
10.0%
1/10 • 2 years
|
|
Eye disorders
eye pain
|
10.0%
1/10 • 2 years
|
|
Eye disorders
watery eye
|
10.0%
1/10 • 2 years
|
|
General disorders
Severe headache (crown top right)
|
20.0%
2/10 • Number of events 3 • 2 years
|
|
Eye disorders
Light sensitivity
|
10.0%
1/10 • 2 years
|
|
General disorders
nausea, body rash
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Pain around eye
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Choroidal Hemorrhage
|
20.0%
2/10 • 2 years
|
|
Eye disorders
Vitreous Hemorrhage
|
20.0%
2/10 • 2 years
|
|
Eye disorders
Shallow retinal detachment
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Hyphema
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Patient had vitrectomy, with PRP laser and Avastin injections done on July 28th due to the non-resol
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Dehiscence of prosthesis superiorly due to retraction
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Conjunctival retraction with dehiscence of prosthesis & possible corneal epithelial ingrowth
|
10.0%
1/10 • 2 years
|
|
Eye disorders
During sep. of iris from cornea bleeding began & didnt allow surgeon to place device in good conditi
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Conjunctival retraction
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Disjunction of the nasal part of the KPRO
|
10.0%
1/10 • 2 years
|
|
Eye disorders
Choroidal detachment and exudative detachment
|
10.0%
1/10 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place