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Keratoprosthesis

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

N/A
Waitlist Available
Research Sponsored by CorNeat Vision Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the 12-months post operation
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of an artificial cornea called the CorNeat Keratoprosthesis. It targets patients with corneal blindness who can't have traditional transplants. The synthetic cornea is implanted to replace the damaged natural one, helping to improve vision.

Eligible Conditions
  • Corneal Diseases
  • Congenital Corneal Opacity
  • Corneal Injuries
  • Corneal Opacity
  • Corneal Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the 12-months post operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the 12-months post operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety Endpoint as Determined by the Frequency and Severity of All Unanticipated Adverse Device-related Events (UADE)
Secondary study objectives
Secondary Effectiveness Endpoint - Improvement in BCDVA

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CorNeat KProExperimental Treatment1 Intervention
Intraocular implantation of the CorNeat KPro

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Who is running the clinical trial?

CorNeat Vision Ltd.Lead Sponsor
3 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Corneal Diseases
40 Patients Enrolled for Corneal Diseases
~2 spots leftby Dec 2025
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