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OpenTrials
Completed

NCT Number: NCT04791696

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

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).

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Key information

Conditions

Corneal Transplant Rejection Corneal Diseases Eye Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UH Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. graft rejection

    Time frame: 1 day

    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.

Secondary outcomes

  1. irreversible graft rejection

    Time frame: 1 day

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2021
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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