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Life 4°C Versus Optisol in Corneal Storage Media

NCT01657500 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-04-18

Study results available
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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.

Conditions

  • Complications of Corneal Transplant

Interventions

OTHER

Corneal donor storage in Optisol GS media solution

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

OTHER

Life 4°C solution for cornea storage

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

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Jonathan Lass, M.D. · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01657500 on ClinicalTrials.gov