Risk Factors for Human Corneal Graft Failure : a Monocentric Retrospective Observational Cohort

Study Overview
=================
Brief Summary
-----------------
Keratoplasty is one of the most common grafts and penetrating keratoplasty is still the technique most used in the world, ahead of lamellar grafts, and is estimated to represent 70% of the total. Graft rejection is still the main cause of failure of this type of surgery, to the extent that nearly a third of all patients will in some way be affected by rejection in due course. Numerous risk factors for rejection have been identified, whether related to the donor, the recipient, or the surgical procedure itself. In addition, many of the studies performed have used univariate analysis only, and yet there is a strong case for multivariate analysis, given the wide range of factors that need to be examined. This study seeks to analyze the rejection rates and the survival of penetrating keratoplasty for a group of patients from Montpellier Hospital (France).

Official Title
-----------------
Risk Factors for Human Corneal Graft Failure : a Monocentric Retrospective Observational Cohort, Montpellier, South of France

Conditions
-----------------
Corneal Transplant Rejection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: -keratoplasty performed in the ophthalmology department of the CHRU of Montpellier between 15/06/2005 and 18/09/2018 Exclusion criteria: a non-optical graft (tectonic and analgesic graft) lamellar graft (DALK (Deep Anterior Lamellar Keratoplasty) and DSAEK (Descemet Stripping Automated Endothelial Keratoplasty)) Silica gel re-dried cornea, duplicates (we included each patient only once per eye) medical record missing from the archives.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| graft rejection | The main criterion studied is the fact that rejection had occurred, defined by the appearance of a rejection line, whether epithelial or endothelial (Khodadoust line), subepithelial infiltrates, or an anterior chamber inflammatory reaction (Tyndall effect, retro corneal precipitates and Descemet folds) with corneal edema in a previously clear graft. Opaque grafts with no clear period in the 2 weeks after grafting were not considered as rejections, but rather as straightforward graft failures. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| irreversible graft rejection | The other criteria studied is irreversible graft rejection, defined as the persistence of a central corneal edema for 3 months despite treatment, and graft failure, defined as a second keratoplasty, or the persistence of a central corneal edema persisting for more than 3 months, whatever the cause (rejection, corneal endothelial cell failure, other). | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cornea / surgery, Corneal Transplantation* / adverse effects, Corneal Transplantation* / methods, Graft Rejection / prevention & control, Humans