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Clinical 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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05694247
Study type Interventional
Source CorNeat Vision Ltd.
Contact Ido Klein, B.Sc, MBA
Phone +972549350507
Email ido@corneat.com
Status Recruiting
Phase N/A
Start date March 2024
Completion date March 2026

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