Trial Outcomes & Findings for Life 4°C Versus Optisol in Corneal Storage Media (NCT NCT01657500)
NCT ID: NCT01657500
Last Updated: 2022-04-18
Results Overview
Endothelial cell loss and graft success were comparable at 6 months for paired donor corneas stored in Optisol GS and Life4°C.
COMPLETED
PHASE3
64 participants
Six months
2022-04-18
Participant Flow
Participant milestones
| Measure |
Life 4°C Media for Cornea Storage
Donor cornea is stored in the Life 4°C media prior to implantation.
Life 4°C solution for cornea storage: Donor cornea is stored in the Life 4°C media prior to implantation.
|
Optisol GS
Donor cornea is stored in the Optisol GS media prior to implantation.
Corneal donor storage in Optisol GS media solution: Donor tissue is preserved in the Optisol media until ready for implantation
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Life 4°C Media for Cornea Storage
Donor cornea is stored in the Life 4°C media prior to implantation.
Life 4°C solution for cornea storage: Donor cornea is stored in the Life 4°C media prior to implantation.
|
Optisol GS
Donor cornea is stored in the Optisol GS media prior to implantation.
Corneal donor storage in Optisol GS media solution: Donor tissue is preserved in the Optisol media until ready for implantation
|
|---|---|---|
|
Overall Study
set impropperly matched
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Life 4°C Versus Optisol in Corneal Storage Media
Baseline characteristics by cohort
| Measure |
Life 4°C Media for Cornea Storage
n=27 Participants
Donor cornea is stored in the Life 4°C media prior to implantation.
Life 4°C solution for cornea storage: Donor cornea is stored in the Life 4°C media prior to implantation.
|
Optisol GS
n=27 Participants
Donor cornea is stored in the Optisol GS media prior to implantation.
Corneal donor storage in Optisol GS media solution: Donor tissue is preserved in the Optisol media until ready for implantation
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
30-85
|
27 years
n=5 Participants
|
27 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six monthsPopulation: Male and female subjects aged from 30-85 years, had FECD, undergoing endothelial keratoplasty, Exclusion criteria: pseudophakic FECD with AC IOL, previous failed keratoplasty, synechiae, corneal scarring impacting graft clarity assessment, uncontrolled uveitis, fellow eye VA 20/200, uncontrolled glaucoma or having a tube shunt placement.
Endothelial cell loss and graft success were comparable at 6 months for paired donor corneas stored in Optisol GS and Life4°C.
Outcome measures
| Measure |
Optisol GS
n=32 Participants
Time after keratoplasty Number of pairs Life 4°C (mean ± SD) Optisol GS (mean ± SD
|
Life 4C
n=32 Participants
|
|---|---|---|
|
Endothelial Cell Loss Post EK for Donor Corneas Preserved in Life 4°C and Optisol GS Corneal Storage Media
|
20 % endothelial cell loss
Standard Deviation 20
|
18 % endothelial cell loss
Standard Deviation 18
|
Adverse Events
Life 4°C Media for Cornea Storage
Optisol GS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jonathan Lass MD
Case Western Reserve Univ and University Hospitals Case Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place