Life 4°C Versus Optisol in Corneal Storage Media

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University Hospital Case Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jonathan Lass, M.D., University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01657500
First received: July 17, 2012
Last updated: August 3, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Complications of Corneal Transplant
Other: Corneal donor storage in Optisol GS media solution
Other: Life 4°C solution for cornea storage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: A Randomized, Prospective, Double Masked Clinical Trial of Life 4°C Versus Optisol GS Corneal Storage Media

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Endothelial cell loss post EK for donor corneas preserved in Life 4°C and Optisol GS corneal storage media [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Graft clarity post EK for donor corneas preserved in Life 4°C and Optisol. storage media [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Life 4°C media for cornea storage
Donor cornea is stored in the Life 4°C media prior to implantation.
Other: Life 4°C solution for cornea storage
Donor cornea is stored in the Life 4°C media prior to implantation.
Other Names:
  • Chondroitin Sulfates
  • Dextrans
  • Gentamicins
  • Streptomicins
  • Complex Mixtures
  • Culture Media, Serum Free
Active Comparator: Optisol GS
Donor cornea is stored in the Optisol GS media prior to implantation.
Other: Corneal donor storage in Optisol GS media solution
Donor tissue is preserved in the Optisol media until ready for implantation
Other Names:
  • Chondroitin Sulfates
  • Dextrans
  • Gentamicins
  • Complex Mixtures
  • Culture Media, Serum Free

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects undergoing EK for FECD only.
  2. Age range of 30-85 years with minimum life expectancy of at least 1 year
  3. Willingness to return to study site at 1 month, 3 months, and 6 months to complete study procedures
  4. Permissible EK procedures with preoperative diagnoses

    • Pseudophakic FECD with posterior capsule supported or suture-fixated posterior chamber intraocular lens (IOL)
    • Phakic FECD
    • EK, phacoemulsification with posterior chamber IOL for phakic FECD with cataract
  5. Stromal vascularization is acceptable
  6. Controlled glaucoma on medication and/or previous trabeculectomy and laser trabeculoplasty is acceptable

Exclusion Criteria:

1. Since EK is suitable only for corneal conditions with endothelial dysfunction, all corneal conditions not associated with endothelial failure that are managed with PKP only are excluded (e.g. keratoconus, stromal dystrophies, traumatic corneal scars).

  • Other exclusions include:
  • Other primary endothelial dysfunction conditions including pseudophakic bullous keratopathy not due to FECD, posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy
  • Pseudophakic FECD with open loop anterior chamber IOL
  • Previous failed keratoplasty, either EK or PKP
  • Central subepithelial or stromal scarring detected preoperatively that could impact graft clarity assessment
  • Anterior or peripheral anterior synechiae
  • Uncontrolled glaucoma > 25 Hg with or without prior filtering surgery or shunt placement.
  • Controlled glaucoma with tube shunt placement.
  • Uncontrolled Uveitis - Fellow eye visual acuity < 20/200
  • Fellow eye already included in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657500

Locations
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46220
United States, Michigan
Verdier Eye Center
Grand Rapids, Michigan, United States, 49546
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44114
United States, Pennsylvania
Central Pennsylvannia Eye Institute
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
University Hospital Case Medical Center
Investigators
Principal Investigator: Jonathan Lass, M.D. University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Jonathan Lass, M.D., Charles I Thomas Professor and Chairman CWRU Department of Ophthalmology and Visual Sciences Director, University Hospitals Eye Institute, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01657500     History of Changes
Other Study ID Numbers: 11-10-20
Study First Received: July 17, 2012
Last Updated: August 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
endothelial keratoplasty

Additional relevant MeSH terms:
Dextrans
Gentamicins
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014