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NCT01657500 · ClinicalTrials.gov registry record · Phase 3
Life 4°C Versus Optisol in Corneal Storage Media
A Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 64
- Enrollment target
NCT01657500: Completed Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
NCT01657500 is a Phase 3 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 64 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01657500, a Phase 3 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 64 participants
- Enrollment target
Study 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.
Primary Outcome
Endothelial cell loss and graft success were comparable at 6 months for paired donor corneas stored in Optisol GS and Life4°C.
Interventions
- OTHER Corneal donor storage in Optisol GS media solution
- OTHER Life 4°C solution for cornea storage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-10 |
| Phase | Phase 3 |
What the finished NCT01657500 record still lists
NCT01657500 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Corneal donor storage in Optisol GS media solution is the first listed.
NCT01657500 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01657500 about?
NCT01657500 is a clinical study titled "Life 4°C Versus Optisol in Corneal Storage Media". 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 o...
What is the current status of trial NCT01657500?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 2011-06. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01657500?
The interventions under investigation include: Corneal donor storage in Optisol GS media solution (OTHER), Life 4°C solution for cornea storage (OTHER).
Who is sponsoring clinical trial NCT01657500?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01657500's enrollment target sits among peer trials
64 1799th of 2000 higher than 201 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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