TerminatedNot Applicable

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

Stopped: The study was voluntarily terminated by the sponsor following emerging safety findings, including device exposure associated with conjunctival retraction. Enrollment was halted to allow further evaluation and optimization of the device and procedure.

Canada, France, Israel15 participantsStarted 2024-06-27

Plain-language 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

Who can participate

Age range21 Years – 80 Years

SexALL

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Inclusion criteria

✓. Male or female aged ≥ 21 and ≤ 80 years on the day of screening
✓. Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
✓. Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In case of unilateral blindness - BCVA of Counting Fingers (CF) from 1 meter or worse in the operated eye
✓. Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation.
✓. Indications that fall under poor candidate for keratoplasty include but are not limited to: herpetic keratitis, vascularized corneal scar, Ocular Cicatricial Pemphigoid, alkali burn, Steven Johnson Syndrome, and limbal stem cell deficiency;
✓. Adequate tear film and lid function
✓. Perception of light in all quadrants
✓. Female patients of childbearing age must have negative pregnancy test at screening and agree to use an effective method of contraception throughout the study.

Exclusion criteria

What they're measuring

Safety Assessment

Timeframe: Throughout 24 months post-op

Trial details

NCT IDNCT05694247

SponsorCorNeat Vision Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-04

View on ClinicalTrials.gov More Corneal Disease trials