MedTrace Logo

A Clinical Study to Evaluate the KeraKlear Keratoprosthesis in Patients With Corneal Opacity

NCT03126903 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-12-10

No results posted yet for this study

Summary

To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis when implanted in an eye with corneal opacity that is at high risk of complications with PK.

Conditions

  • Corneal Blindness

Interventions

DEVICE

KeraKlear Non-Penetrating Keratoprosthesis

The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • ClinReg Consulting Services, Inc.

    collaborator OTHER

  • KeraMed, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-03-22
Primary Completion
2019-11-30
Completion
2019-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03126903 on ClinicalTrials.gov