Trials / Terminated
TerminatedNCT03126903
A Clinical Study to Evaluate the KeraKlear Keratoprosthesis in Patients With Corneal Opacity
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- KeraMed, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-03-22
- Primary completion
- 2019-11-30
- Completion
- 2019-11-30
- First posted
- 2017-04-25
- Last updated
- 2019-12-10
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03126903. Inclusion in this directory is not an endorsement.