Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT03126903
Status:
TERMINATED
Last Update Posted:
2019-12-10
First Post:
2017-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the KeraKlear Keratoprosthesis in Patients With Corneal Opacity
Sponsor:
KeraMed, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Probable Benefit of the KeraKlear Non-Penetrating Keratoprosthesis in Subjects With Corneal Opacity With Poor Prognosis for Corneal Transplant
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
KeraMed is being discontinued because it is no longer feasible due to the slow pace of recruitment and insufficient financial resources.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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. A prospective, multicenter, clinical trial, designed to demonstrate the safety and performance of the KeraKlear Non-Penetrating Keratoprosthesis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R44EY021664-01 | NIH | None | https://reporter.nih.gov/quic… | View |