Cornea Preservation Time Study
Condition: Cornea Preservation Time; Endothelial Keratoplasty; Transplant Success; Endothelial Cell Density
MeSH terms: Corneal Diseases
Intervention: Cornea tissue transplant; Cornea tissue transplant
Intervention description: Cornea tissue preserved 0 to 7 days; Cornea tissue preserved 8 to 14 days.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1174.0
Sex: All
Minimum age: 30 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: cornea; transplant; preservation; endothelial keratoplasty

Summary:

      The purpose of this study is to determine if the 3-year graft failure rate following
      endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14
      days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or
      fewer days are used.
    

Eligibility criteria:

        Study Participant Eligibility Criteria

          -  Study Participant Inclusion Criteria

               1. Age range 30-<91 years with minimum life expectancy of at least 3 years.

               2. Willingness to return for follow-up study visits at 1 day, 1 week, 1 month, 6
                  months, 1 year, 2 years and 3 years.

               3. Fluent in English or Spanish.

          -  Study Participant Exclusion Criteria 1) Decisionally and/or cognitively impaired

        Study Eye Eligibility Criteria

          -  Study Eye Inclusion Criteria

               1. Endothelial keratoplasty (EK) is scheduled between 10 and 60 days after
                  enrollment

                    -  The 10-day requirement relates to the need to be able to randomly assign the
                       eye to either intervention group.

                    -  The 60-day requirement relates to the need to have current eligibility and
                       enrollment data at the time of surgery. If surgery is postponed to >60 days
                       after the initial enrollment visit, a new Baseline Visit and eligibility
                       assessment will have to be performed.

               2. Presence of a condition related to endothelial dysfunction which will be treated
                  by EK.

          -  Eligible indications for EK include:

               -  Presence of Fuchs endothelial corneal dystrophy (FECD) meeting at least one of
                  the following:

                    -  Phakic FECD

                    -  Phakic FECD with cataract

                         -  Triple procedure including EK for FECD, cataract extraction and
                            posterior chamber intraocular lens implantation (IOL) is allowed

                    -  Aphakic FECD

                    -  Pseudophakic FECD with posterior capsule supported, suture-fixated, or
                       sulcus-supported posterior chamber IOL

               -  Aphakic or pseudophakic corneal edema with posterior capsule supported,
                  suture-fixated, or sulcus-supported posterior chamber IOL without FECD

          -  Study Eye Exclusion Criteria

               1. Prior EK

               2. Indication for surgery that is not suitable for EK (e.g, keratoconus, stromal
                  dystrophies and scars)

               3. Presence of a condition that has a very high probability for failure (e.g.,
                  failed EK or Penetrating Keratoplasty (PKP), heavily vascularized cornea,
                  uncontrolled uveitis)

               4. Other primary endothelial dysfunction conditions including posterior polymorphous
                  corneal dystrophy and congenital hereditary corneal dystrophy

               5. Anterior chamber IOL in study eye prior to or anticipated during EK

               6. Planned intraocular lens exchange of an anterior chamber IOL with a posterior
                  chamber IOL in study eye at time of study EK

               7. Pre-operative central sub-epithelial or stromal scarring that the investigator
                  believes is visually significant and could impact post-operative stromal clarity
                  assessment

               8. Stromal vascularization that is visually significant (by investigator's judgment)

               9. Presence of anterior synechiae (iris to cornea)

              10. Peripheral anterior synechiae (iris to angle) in the angle greater than a total
                  of three clock hours

              11. Hypotony (Intraocular pressure <10 mm Hg)

              12. Uncontrolled (defined as intraocular pressure > 25mm Hg) glaucoma with or without
                  prior filtering surgery or shunt or mini-shunt placement.

                    -  A shunt or mini-shunt is any device implanted to lower intraocular pressure
                       through an external route (e.g Ahmed) or internal route (e.g. Glaukos) that
                       is present in the anterior chamber angle or extends into the anterior
                       chamber.

              13. Controlled glaucoma with prior shunt or mini-shunt placement for glaucoma

                    -  Note: FECD or pseudophakic/aphakic corneal edema with posterior chamber IOL
                       that also have undergone filtering surgery (without shunt or mini-shunt) in
                       which glaucoma is currently considered under control will be eligible

              14. Fellow eye visual acuity < 20/200 that is not correctable with EK

        Eligibility Criteria for Second Study Eye

          1. Study participant has already enrolled one eye

          2. The second eye meets all study eye inclusion and exclusion criteria (2.2.2 and 2.2.3)

          3. EK surgery in second eye is not planned within 6 weeks of EK on first study eye