NCT05694247

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

A Single Arm, Open Label, Multicenter Clinical Investigation to Evaluate the Clinical Safety and Performance of the CorNeat Keratoprosthesis, for Treatment of Corneal Blindness

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: CorNeat Vision Ltd. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DEVICE	CorNeat KPro	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.

Timeline

• Start date: 2024-06-27
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2023-01-23
• Last updated: 2026-03-18

Locations

6 sites across 4 countries: Canada, France, Israel, Netherlands