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First in Human (FIH) Study to Assess Safety and Efficacy of the CorNeat KPro for the Treatment of Corneal Blindness

NCT04485858 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-09-24

Study results available
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Summary

Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal blindness

Conditions

  • Corneal Disease
  • Corneal Opacity
  • Corneal Injuries

Interventions

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

Sponsors & Collaborators

  • CorNeat Vision Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-03
Primary Completion
2023-06-01
Completion
2023-06-01
FDA Device
Yes

Countries

  • United States
  • Canada
  • France
  • Israel
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04485858 on ClinicalTrials.gov