CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 64 enrolled
Drug / intervention
Corneal donor storage in Optisol GS media solution +1 moreother
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.

Search/NCT01657500
NCT01657500Phase 3Completed

A Randomized, Prospective, Double Masked Clinical Trial of Life 4°C Versus Optisol GS Corneal Storage Media

University Hospitals Cleveland Medical Center·interventional·Posted Aug 6, 2012·Updated Apr 18, 2022

In Brief

A Phase 3 clinical trial evaluating Corneal donor storage in Optisol GS media solution and Life 4°C solution for cornea storage for Complications of Corneal Transplant. Completed, enrolled 64 participants across 4 sites.

Detailed Summary

The purpose of this study is to compare the success of storing a donor cornea in Optisol GS, the current standard vs. storing the donor cornea in Life4°C, a newer solution. The donor cornea to be used for EK will be provided by an eye bank and will have been stored in either an Optisol GS solution or a Life 4°C solution. At 6 months, the doctors will determine whether there are any comparable differences in cell loss and graft clarity between the two donor corneas.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2012
Enrollment StartJun 1, 2011
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.9 years ago

Interventions

Corneal donor storage in Optisol GS media solutionother

Donor tissue is preserved in the Optisol media until ready for implantation

Life 4°C solution for cornea storageother

Donor cornea is stored in the Life 4°C media prior to implantation.