Life 4°C Versus Optisol in Corneal Storage Media
Condition: Complications of Corneal Transplant
Intervention: Corneal donor storage in Optisol GS media solution; Life 4°C solution for cornea storage
Intervention description: Donor tissue is preserved in the Optisol media until ready for implantation; Donor cornea is stored in the Life 4°C media prior to implantation.
Intervention MeSH terms: Gentamicins; Dextrans; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: endothelial keratoplasty

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.
    

Eligibility 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