Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty

Study Overview
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Brief Summary
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Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.

Official Title
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A Prospective, Randomized, Single Center Study Evaluating Use of Surgeon- and Eye Bank-prepared Donor Tissue for Descemet's Stripping and Endothelial Keratoplasty, a Type of Cornea Transplant

Conditions
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Corneal Edema, Fuchs Endothelial Dystrophy

Intervention / Treatment
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* Procedure: Descemet's stripping endothelial keratoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: candidate for Descemet's stripping with endothelial keratoplasty at least 21 years old willing and able to return for scheduled follow-up visits reads and signs Informed Consent document Exclusion Criteria: visual acuity of less than 20/400 in fellow eye known sensitivity to planned study concomitant medications

Ages Eligible for Study
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Minimum Age: 21 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 |
| --- | --- |
| Active Comparator: 1<br>An Eye bank pre-cut the donor grafts used for the corneal transplant procedures. | Procedure: Descemet's stripping endothelial keratoplasty<br>* Small incision corneal transplant procedure to treat dysfunctional endothelium.<br>|
| Active Comparator: 2<br>The surgeon dissected the donor grafts used for the transplant procedures. | Procedure: Descemet's stripping endothelial keratoplasty<br>* Small incision corneal transplant procedure to treat dysfunctional endothelium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Cell Loss | Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100. | 6 months after grafting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Vision |  | 6 months and 1 year after grafting | 
| Graft Dislocation |  | 1 day to 1 month after grafting |