At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,174 enrolled
Drug / intervention
Cornea tissue transplant +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Corneal Preservation Time on Long-Term Graft Success
In Brief
A Phase 4 clinical trial evaluating Cornea tissue transplant for Cornea Preservation Time and 3 related conditions. Completed, enrolled 1,174 participants across 40 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCornea Preservation Time, Endothelial Keratoplasty, Transplant Success, Endothelial Cell Density
CountriesUnited States
CollaboratorsNational Eye Institute (NEI), Jaeb Center for Health Research
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2012
Enrollment StartApr 2012
Primary CompletionJun 2017
TodayJul 2026
First PostedFeb 23, 2012
Enrollment StartApr 16, 2012
Primary CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 14.4 years ago
Interventions
Cornea tissue transplantbiological
Cornea tissue preserved 0 to 7 days
Cornea tissue transplantbiological
Cornea tissue preserved 8 to 14 days.