First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness
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|ClinicalTrials.gov Identifier: NCT04485858|
Recruitment Status : Not yet recruiting
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Corneal Disease Corneal Opacity Corneal Injuries||Device: CorNeat KPro||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Open Label, Single Arm, First in Human (FIH) Clinical Study to Assess Safety and Efficacy of the CorNeat Keratoprosthesis for the Treatment of Corneal Blindness|
|Estimated Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: CorNeat KPro
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) [ Time Frame: Throughout the 12 months follow up period ]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
- Primary effectiveness Endpoint - Device retention rate [ Time Frame: 12-months ]Incidence of device retention as determined by slit-lamp biomicroscopy at last follow up visit
- Secondary effectiveness Endpoint - Improvement in BCDVA [ Time Frame: 12-months ]Improvement in BCDVA (using ETDRS visual acuity chart, where applicable) compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485858
|Contact: Gerry Tal, B.Sc, MBA||+972 firstname.lastname@example.org|
|Contact: Ido Klein, B.Sc, MBAemail@example.com|