Cornea Preservation Time Study

Study Overview
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Brief Summary
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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.

Detailed Description
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When the donor cornea is removed from the person who died, it is prepared for transplantation by an eye bank. The donor cornea is placed into a liquid that helps preserve the cornea until it is transplanted. The Food and Drug Administration (FDA) has approved storage of the cornea in this liquid for up to 14 days before the transplant. The purpose of this study is to see if the length of time the donor cornea is kept in the preservation liquid before the transplant affects the likelihood of the transplant being successful. We will follow participants for 3 years after transplant to see if there are any differences in transplant success or in the number of transplanted endothelial cells (the layer of cells that line the undersurface of the cornea) on the corneas that were preserved for 7 days or less compared to those preserved between 8 and 14 days. We have no reason to believe that there is any greater risk for transplant failure with either preservation time group.

Official Title
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Effect of Corneal Preservation Time on Long-Term Graft Success

Conditions
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Cornea Preservation Time, Endothelial Keratoplasty, Transplant Success, Endothelial Cell Density

Intervention / Treatment
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* Biological: Cornea tissue transplant
* Biological: Cornea tissue transplant


Participation Criteria
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Eligibility Criteria
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Study Participant Eligibility Criteria Study Participant Inclusion Criteria Age range 30-<91 years with minimum life expectancy of at least 3 years. Willingness to return for follow-up study visits at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years. Fluent in English or Spanish. Study Participant Exclusion Criteria 1) Decisionally and/or cognitively impaired Study Eye Eligibility Criteria Study Eye Inclusion Criteria 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. 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 Prior EK Indication for surgery that is not suitable for EK (e.g, keratoconus, stromal dystrophies and scars) 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) Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy Anterior chamber IOL in study eye prior to or anticipated during EK Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study EK Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment Stromal vascularization that is visually significant (by investigator's judgment) Presence of anterior synechiae (iris to cornea) Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours Hypotony (Intraocular pressure <10 mm Hg) 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. 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 Fellow eye visual acuity < 20/200 that is not correctable with EK Eligibility Criteria for Second Study Eye Study participant has already enrolled one eye The second eye meets all study eye inclusion and exclusion criteria (2.2.2 and 2.2.3) EK surgery in second eye is not planned within 6 weeks of EK on first study eye

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 0-7d Preservation Time Group<br>Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 0 to 7 days prior to transplant. | Biological: Cornea tissue transplant<br>* Cornea tissue preserved 0 to 7 days<br>|
| Other: 8-14d Preservation Time Group<br>Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 8 to 14 days prior to transplant. | Biological: Cornea tissue transplant<br>* Cornea tissue preserved 8 to 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery | Graft failure, defined as the occurrence of one of the following within 3 years of surgery: Regrafting of the study eye for any reason Cornea which remains cloudy without clearing, according to the following: cloudy cornea on the first postoperative day which does not clear within 8 weeks OR cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing. | Study eye will be assessed for this outcome for 3 years following surgery | 
| Endothelial Cell Density (ECD) | Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery. | 3 years from surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cornea, transplant, preservation, endothelial keratoplasty