Trials / Completed
CompletedNCT01537393
Cornea Preservation Time Study
Effect of Corneal Preservation Time on Long-Term Graft Success
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,174 (actual)
- Sponsor
- Case Western Reserve University · Academic / Other
- Sex
- All
- Age
- 30 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or fewer days are used.
Detailed description
When the donor cornea is removed from the person who died, it is prepared for transplantation by an eye bank. The donor cornea is placed into a liquid that helps preserve the cornea until it is transplanted. The Food and Drug Administration (FDA) has approved storage of the cornea in this liquid for up to 14 days before the transplant. The purpose of this study is to see if the length of time the donor cornea is kept in the preservation liquid before the transplant affects the likelihood of the transplant being successful. We will follow participants for 3 years after transplant to see if there are any differences in transplant success or in the number of transplanted endothelial cells (the layer of cells that line the undersurface of the cornea) on the corneas that were preserved for 7 days or less compared to those preserved between 8 and 14 days. We have no reason to believe that there is any greater risk for transplant failure with either preservation time group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Cornea tissue transplant | Cornea tissue preserved 0 to 7 days |
| BIOLOGICAL | Cornea tissue transplant | Cornea tissue preserved 8 to 14 days. |
Timeline
- Start date
- 2012-04-16
- Primary completion
- 2017-06-30
- Completion
- 2017-06-30
- First posted
- 2012-02-23
- Last updated
- 2018-04-23
- Results posted
- 2018-04-23
Locations
40 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01537393. Inclusion in this directory is not an endorsement.