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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04791696
Enrollment
200
Registered
2021-03-10
Start date
2020-04-01
Completion date
2020-04-01
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Transplant Rejection

Keywords

Cornea / surgery, Corneal Transplantation* / adverse effects, Corneal Transplantation* / methods, Graft Rejection / prevention & control, Humans

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).

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
graft rejection1 dayThe 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.

Secondary

MeasureTime frameDescription
irreversible graft rejection1 dayThe 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026